Loading…
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
86pct
94d open
vs 7,393 other HR bills in the 115th — cohort avg 50d
(This measure has not been amended since it was passed by the House on July 12, 2017. The summary of that version is repeated here.) FDA Reauthorization Act of 2017 TITLE I--FEES RELATING TO DRUGS Prescription Drug User Fee Amendments of 2017 (Sec. 102) This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for brand name drugs. User fees are eliminated for supplemental new drug applications and drug manufacturing facilities. A prescription drug program fee replaces the prescription drug product fee. This annual fee is assessed on a new drug application holder for each approved drug for up to five drugs. The total user fee revenue amount is adjusted annually for changes in review process capacity needs, to provide for operational reserves, and for additional direct costs. Eighty percent of revenues must be generated by prescription drug program fees, with the remainder from application fees. (Sec. 103) The bill extends through FY2022 requirements for annual reports and consultation by the FDA on reauthorization of brand name drug user fees. TITLE II--FEES RELATING TO DEVICES Medical Device User Fee Amendments of 2017 (Sec. 203) The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA’s authority to waive or reduce device user fees in the interest of public health is eliminated. (Sec. 204) The bill extends through FY2022 requirements for annual reports and consultation by the FDA on reauthorization of user fees for medical devices. (Sec. 205) The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards. (Sec. 206) The bill extends through FY2022 the FDA's authority to accredit third parties to review premarket notifications for medical devices. The bill revises the types of devices that third parties may review. (Sec. 207) Submissions to the FDA regarding medical devices must be solely in electronic format. TITLE III--FEES RELATING TO GENERIC DRUGS Generic Drug User Fee Amendments of 2017 (Sec. 302) Generic drug applications submitted by government entities for non-commercial drugs are not subject to user fees. (Sec. 303) The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual generic drug applicant program fee is assessed on holders of approved generic drug applications. The amount of the fee is based on the number of applications held. Of total user fee revenue, 35% must be generated from this fee. Application holders who do not pay this fee may not market their drugs. (Sec. 304) The bill extends through FY2022 requirements for annual reports and consultation by the FDA on reauthorization of user fees for generic drugs. TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS Biosimilar User Fee Amendments of 2017 (Sec. 403) The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplemental biosimilar applications and biosimilar manufacturing facilities. An annual biosimilar biological product program fee is assessed on biosimilar application holders for each approved biosimilar for up to five biosimilars. The bill sets the annual amount of revenue that must be generated by user fees. The FDA must determine the percentage of revenue generated by each fee. The total fee revenue amount is adjusted annually for changes in review process capacity needs and to provide for operational reserves. TITLE V--PEDIATRIC DRUGS AND DEVICES (Sec. 501) The bill extends through FY2022 and revises the National Institutes of Health (NIH) program to conduct pediatric studies of drugs. The NIH, in developing its list of priority issues in pediatric therapeutics, must consider identification of biomarkers for pediatric conditions. (Sec. 502) The bill revises requirements for the FDA to report on pediatric use of medical devices. The bill extends and revises the authorization for certain medical devices for pediatric patients to be sold above cost under the humanitarian device exemption. The bill extends and revises grants for consortia to facilitate development of pediatric medical devices. The FDA must convene a meeting on the development, approval, and labeling of pediatric medical devices. (Sec. 503) The FDA must meet with applicants for approval of new drugs or biological products to discuss, upon request, the initial pediatric study plan for medications to treat serious conditions and to discuss deferral or waiver of pediatric assessments. (Sec. 504) The bill revises the requirement for pediatric assessments to be submitted with applications for FDA approval of new medications. Sponsors of new medications for adult cancer, including orphan drugs, that target a molecule relevant to pediatric cancer must complete an investigation to yield pediatric study data to inform potential pediatric labeling of the medication. (Orphan drugs are medications for rare conditions.) The FDA must publish a list of target molecules considered relevant to pediatric cancer and a list of molecules for which pediatric study requirements are waived. The FDA must convene a meeting regarding the lists and the revisions to the pediatric assessment requirement. The bill revises FDA reporting requirements regarding pediatric studies and assessments. The Government Accountability Office (GAO) must report on the effectiveness of requiring pediatric assessments and investigations in the development of medications for pediatric cancer. (Sec. 505) The FDA must provide additional information to the internal committee that reviews requests for pediatric studies. (Currently, completion of pediatric clinical studies requested by the FDA extends the patents or marketing exclusivity period for a medication by six months, with exceptions.) This committee must develop and implement a plan to achieve earlier submission of pediatric studies. The FDA must: (1) act within 120 days on proposed pediatric study requests and proposed amendments to requests, and (2) report on the lack of pediatric labeling for orphan drugs. The FDA's Office of Pediatric Therapeutics must have a staff member with expertise in neonatology. TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS (Sec. 601) The bill extends through FY2022: (1) marketing exclusivity for certain chemical variants of approved drugs; (2) Critical Path Public-Private Partnerships; and (3) support to defray the costs of developing drugs, devices, and medical food for rare conditions. (Sec. 604) Except in cases of a drug shortage or certain importation of drugs from Canada, prescription drugs manufactured outside the United States may only be imported if authorized by the manufacturer and appropriately labeled. The bill establishes a penalty for manufacturing, dispensing, or selling a counterfeit drug. (Sec. 605) The bill revises the definition of patient experience data, for purposes of collecting such data as part of the medical product development process, to specifically include physical and psychosocial impacts of a condition, therapy, or clinical investigation. (Sec. 606) The communication plan for a risk evaluation and mitigation strategy may include informing health care providers about drug formulations or properties and how those formulations or properties may be related to serious adverse drug events. (Sec. 607) For a medication to be approved as an orphan drug with seven years of marketing exclusivity when it is the same medication for the same condition as an already approved orphan drug, the sponsor of the new medication must demonstrate that the new medication is clinically superior to the approved medication. (Sec. 608) The bill expands to cover brand name drugs provisions that allow generic drugs to be approved and marketed without labeling for pediatric indications when the pediatric indications are protected by patent or marketing exclusivity. (Sec. 610) The FDA, in coordination with the NIH, must convene a meeting to discuss clinical trial inclusion and exclusion criteria. The FDA must report on the meeting and issue guidance regarding eligibility criteria for clinical trials. The GAO must report on individual access to investigational drugs through the expanded access program. (Expanded access, also known as compassionate use, allows patients to be treated with an investigational drug outside of a clinical trial.) The FDA must streamline review by institutional review boards of expanded access protocols for individual patients. The manufacturer or distributor of an investigational drug for a serious condition must publish its expanded access policy not later than 15 days after the drug is designated a breakthrough therapy, fast track product, or regenerative advanced therapy. (Sec. 611) The bill revises the priority review program for medications for tropical diseases to limit eligibility to applications that include new clinical investigations that were not submitted as part of an application in certain foreign countries. TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS (Sec. 701) The bill revises provisions regarding FDA inspections of establishments that manufacture or process medical devices. The biannual inspection schedule for medical device establishments handling higher risk devices is replaced with a risk-based schedule. In establishing the risk-based schedule, the FDA must consider an establishment's participation in international medical device audit programs. (Sec. 702) The FDA must adopt uniform processes and standards for inspections of domestic and foreign medical device establishments. Upon request, the FDA must provide to the person in charge of a medical device establishment feedback regarding the person's proposals to address certain issues identified during an inspection. (Sec. 703) The bill extends through FY2022 accreditation by the FDA of third parties to conduct inspections of medical device establishments. (Sec. 704) The bill revises provisions regarding FDA certification of medical devices for export. The FDA must provide the basis for denying requests for certification of products for export as meeting FDA requirements for domestic products. A person denied such a certification may request supervisory review of that decision. Products from a medical device establishment that an inspector found to be contaminated or insanitary may be certified for export if the person in charge of the establishment has agreed to a plan to correct the issues identified during the inspection. (Sec. 705) The FDA may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of inspecting medical device establishments. (Sec. 706) The FDA may approve or classify a medical imaging device intended to be used with an approved contrast agent if differences from the approved use of the contrast agent do not adversely affect the safety and effectiveness of the contrast agent. (Contrast agents are substances used to enhance the visibility of body structures in medical imaging.) The FDA center that reviews medical devices has primary jurisdiction over such reviews. After authorization of a medical imaging device that makes new use of a contrast agent, the sponsor of the approved contrast agent may submit a supplemental application for the new use of the contrast agent. (Sec. 707) The bill revises how accessories to medical devices are classified. The FDA must classify accessories based on the risks when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Applications for approval or clearance of a medical device used with an unclassified accessory may request that the FDA classify the accessory. The FDA's response to the application must grant or deny the request for classification of the accessory. The FDA must periodically classify suitable medical device accessories that have been approved for marketing as low risk devices. Manufacturers and importers of accessories approved for marketing may request classification of the accessories. (Sec. 708) In order to provide timely and reliable information on the safety and effectiveness of medical devices that have been approved, cleared, or classified, the FDA must support pilot projects that use electronic health data to generate safety and active surveillance data and inform methods and programs to support safety and active surveillance activities. (Sec. 709) The FDA must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription. The FDA must determine whether premarket notification is required for over-the-counter hearing aids to provide reasonable assurance of safety and effectiveness. State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids. The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices. (Sec. 710) The FDA must report on the continued quality, safety, and effectiveness of medical devices after servicing. The report must contain information including the current authority of the FDA to regulate medical device servicing and how the FDA could improve its regulation of servicing. TITLE VIII--IMPROVING GENERIC DRUG ACCESS (Sec. 801) The FDA must prioritize review of, and act within eight months of submission on, generic drug applications for drugs for which there is a shortage or for which there are not more than three approved products and no blocking patents or exclusivities. To be eligible for priority review, an applicant must submit, at least 60 days in advance of the application, information to the FDA on facilities involved in the manufacturing and testing of the drug. The FDA may expedite inspection of such manufacturing facilities. The FDA must publish a list of brand name drugs for which all patents and exclusivities have expired and no generic drug application has been approved. (Sec. 802) Upon request, the FDA must provide review status updates to applicants with pending generic drug applications. (Sec. 803) The FDA may, upon the request of an applicant for approval of a generic drug, designate a generic drug as a competitive generic therapy and expedite the development and review of the application. A drug may be designated as a competitive generic therapy if there is not more than one approved, marketed drug that is the same drug. (Sec. 804) Holders of approved brand name or generic drug applications must notify the FDA: (1) 180 days prior to withdrawing a drug from sale, or as soon as practicable, and provide specified information including the reason for withdrawal; (2) within 180 days of approval of a drug if the drug will not be available for sale within 180 days of approval and provide specified information including the reason the drug is not for sale; and (3) within 180 days of enactment of this bill of whether their drugs on the FDA’s list of marketed drugs are marketed. The FDA must update its list of marketed drugs based on this information. (Sec. 805) The FDA must annually report information regarding petitions for permission to seek approval for a generic drug application for a drug that differs from the brand name drug. (Sec. 806) The FDA must implement a protocol to expedite review of responses to inspection reports pertaining to certain drug applications, including applications for drugs in a shortage or drugs for which approval is dependent on remediation of conditions identified in the inspection report. (Sec. 807) The FDA must report quarterly on generic drug applications, including information regarding applications subject to priority review or expedited development and review and withdrawals of generic drug applications. (Sec. 808) First approved applicants for a competitive generic therapy are granted a 180-day marketing exclusivity period. There may be only one such period for a drug. This exclusivity period is forfeited by an applicant if the applicant fails to market the drug within 75 days after approval. (Sec. 809) For FY2013-FY2017, the GAO must report on the rate of approval of generic drug applications upon completion of the FDA's first review of an application. For years when the rate is below 20%, the GAO must report on the reasons for the low rate. The GAO must report on whether there are ways the generic drug review process could be improved to increase the rate of approvals upon first review. TITLE IX--ADDITIONAL PROVISIONS (Sec. 902) The FDA must annually publish information regarding the past year’s inspections of drug or medical device facilities, including the amount of time between steps in the inspection process. (Sec. 903) The bill revises requirements for performance reports under user fee provisions for prescription drugs, medical devices, generic drugs, and biosimilars, including to require quarterly publication of information regarding guidance and meetings. Performance reports must include: (1) an analysis of changes in the number of full time equivalents hired under user fee agreements and the number funded under the FDA budget, (2) an analysis of changes in user fee revenue amounts and review costs, and (3) the number of employees in specified FDA offices for whom time reporting is required and the number for whom it is not required. (Sec. 904) User fee performance reports must include an analysis of: (1) the number of product applications filed and approved, (2) whether the relevant FDA review office has met performance enhancement goals, and (3) circumstances affecting the ability of the FDA to meet review time and performance enhancement goals. The FDA must annually submit a corrective action report to Congress as part of user fee reporting. If the FDA determines that fiscal year goals were met, the report must include recommendations on ways to improve the product review process. If goals were not met, the report must include a description of the circumstances under which goals were missed and efforts to improve the FDA’s ability to meet the goals. Each fiscal year, as requested, representatives of the FDA must meet with members of Congress and participate in a congressional hearing regarding user fee reports. (Sec. 905) The GAO must report on FDA expenses related to facility maintenance and renovation for FY2012-FY2019. The report must include an analysis of the FDA’s ability to further its public health mission and review medical products by incurring such expenses. Beginning FY2024, the bill prohibits the use of user fees for: (1) maintenance, renovation, and repair of facilities; and (2) acquisition, maintenance, and repair of materials and supplies that are not necessary scientific equipment.
Yes
190
No
2
Present
0
Not Voting
8
Party Breakdown
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (141)
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Message on Senate action sent to the House.
Passed Senate without amendment by Yea-Nay Vote. 94 - 1. Record Vote Number: 187.
SenatePassed/agreed to in Senate: Passed Senate without amendment by Yea-Nay Vote. 94 - 1. Record Vote Number: 187.
SenateMeasure laid before Senate by motion. (consideration: CR S4782-4787)
Motion to proceed to consideration of measure agreed to in Senate by Unanimous Consent.
Cloture on the motion to proceed to the measure invoked in Senate by Yea-Nay Vote. 96 - 1. Record Vote Number: 185. (CR S4787)
SenateBills with similar content found using semantic analysis.
Sources: Congress.gov · House Clerk roll-call votes
| #185 | senate | On Cloture on the Motion to Proceed | Cloture on the Motion to Proceed Agreed to (96-1, 3/5 majority required) | August 3, 2017 |
| #187 | senate | On Passage of the Bill | Bill Passed (94-1) | August 3, 2017 |
2019 · first_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 1781 - Payment Commission Data Act of 2019 H.R. 938 - the BLOCKING Act of 2019 H.R. 1520 - the Purple Book Continuity Act of 2019 H.R. 1503 - the Orange Book Transparency Act of 2019 H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R. 965 - the CREATES Act of 2019 no specific bills, PDUFA, antimicrobial resistance, importation, companion diagnostics, user fee sequester, innovation, biomarkers, drug importation, 340b, comparative effectiveness, gift disclosure, oncology, personalized medicine, price transparency, adherence, Vaccines for Children Program
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2019 · first_quarter · Pharmacy
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills, Import Safety, drug development policy, drug shortages, supply chain integrity, Innovation, reimportation H.R. 1781 - Payment Commission Data Act of 2019 H.R. 938 - the BLOCKING Act of 2019 H.R. 1503 - the Orange Book Transparency Act of 2019 H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019
Client expense: Not reported · Firm income: $50,000
2018 · fourth_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Motion to proceed to measure considered in Senate.
Cloture motion on the motion to proceed to the measure presented in Senate. (CR S4663)
Motion to proceed to consideration of measure made in Senate. (CR S4663)
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 174.
Received in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5454-5477)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5454-5477)
DEBATE - The House proceeded with forty minutes of debate on H.R. 2430.
Considered under suspension of the rules. (consideration: CR H5454-5483)
Mr. Walden moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 138.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 115-201.
Congress.gov source codes: 5000, H12200
Ordered to be Reported (Amended) by the Yeas and Nays: 54 - 0.
Committee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
| July 11, 2017 |
| Introduced in House | May 16, 2017 |
| Enrolled Bill | -- |
| S 1069 |
115th |
| Related bill |
| S 1062 | 115th | Related bill |
| S 1048 | 115th | Related bill |
| HR 2376 | 115th | Related bill |
| HR 1652 | 115th | Related bill |
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Health and Human Services Department Reform Health Care Reform (access to dental care, other dental-related issues) Affordable Care Act Repeal and Replace (dental-related programs) Better Care Reconciliation Act of 2017 (H.R. 1628, nature of a substitute) Graham-Cassidy health reform proposal (H.R. 1628, nature of a substitute) Childrens Health Insurance Program (CHIP) reauthorization H.R. 6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act H.R. 860-HEALTHIER Act of 2017 H.R. 1606-Dentist and Optometric Care Access Act (DOC Access Act) H.R. 1628-American Health Care Act of 2017 H.R. 1876-Good Samaritan Health Professionals Act of 2017 H.R. 2422-Action for Dental Health Act of 2017 H.R. 2430-FDA Reauthorization Act of 2017 H.R. 3921-HEALTHY KIDS Act H.R. 4684-Ensuring Access to Quality Sober Living Act of 2018 H.R. 5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R. 5261-TEACH to Combat Addiction Act of 2018 H.R. 5327-Comprehensive Opioid Recovery Centers Act of 2018 H.R. 5333-Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 H.R. 5687-Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act H.R. 5774-Combatting Opioid Abuse for Care in Hospitals (COACH) Act H.R. 5776-Medicare and Opioid Safe Treatment (MOST) Act H.R. 5806-21st Century Tools for Pain and Addiction Treatments H.R. 5812-Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigating Strategies (CONNECTIONS) Act H.R. 6689-Ensuring Lasting Smiles Act H.R. 7000-Tribal Tax Empowerment and Jobs Act of 2018 S. 934-FDA Reauthorization Act of 2017 S. 1827-KIDS Act of 2017 S. 2315-Over-the-Counter Drug Safety, Innovation, and Reform Act S. 2456-CARA 2.0 Act of 2018 S. 2680-Opioid Crisis Response Act of 2018 S. 3016-Action for Dental Health Act of 2018
Client expense: $530,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Treasury, Dept of
2018 · fourth_quarter · Medical/Disease Research/Clinical Labs
Legislation and policies related to: Pediatric and childrens health research Nursing research Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 2430/S. 934 - FDA Reauthorization Act of 2017 S. 292/H.R. 820 - Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2017 S. 456/H.R. 1231 - Research to Accelerate Cures and Equity (RACE) for Children Act
Client expense: Not reported · Firm income: $23,450
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)
2018 · fourth_quarter · Health Issues
H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act
Client expense: $79,366 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Client expense: $580,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2018 · fourth_quarter · Budget/Appropriations
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act Drug importation, generally; Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469) Virtual Medicare Diabetes Prevention Program Issues related to the 340B Drug Pricing Program, generally; 340B Protecting Access for the Underserved and Safety-Net Entities (340 PAUSE) Act (H.R. 4710) Issues related to the FDA Reauthorization Act (Pub.L. 115-52) Improving Access To Affordable Prescription Drugs Act (H.R. 1776/S.771)
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bil1s, innovation, non-interference, 340B, Hepatitis C, HPV, Shingles, anti-microbial resistance, transparency, Pandemic All Hazards Preparedness Act reauthorization
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Prescription Drug User Fee Act (PDUFA) and associated policies, 340B, Biosimilars, Orphan drugs
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Tobacco
Issues related to lung disease treatment and prevention, and public health; Issues related to tobacco cessation; Issues related to smokefree air; Issues related to Tobacco 21; Issues related to the Tobacco Control Act: Issues related to tobacco smuggling; Issues related to the Affordable Care Act; Issues related to the President's Budget; Issues related to tobacco prevention; H.R.5, Regulatory Accountability Act of 2017; H.R.21, Midnight Rules Relief Act of 2017; H.R.564, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017; H.R.729, Tobacco Excise Tax and Parity Act of 2017; H.R.1136, FDA Deeming Authority Clarification Act of 2017;H.R.1662, To amend title 38, United States Code, to prohibit smoking in any facility of the Veterans Health Administration, and for other purposes.; H.R.1848, Veterans Affairs Medical Scribe Pilot Act of 2017; H.R.2194, Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017; H.R.2430, FDA Reauthorization Act of 2017; H.R.5961 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; S.2976 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R.6385 - Department of State, Foreign Operations, and Related Programs Appropriations Act, 2019; S.3108 - Department of State, Foreign Operations, and Related Programs Appropriations Act, 2019; H.R.4273, Tobacco to 21 Act; S.294, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017; S.934, FDA Reauthorization Act of 2017; S.951, Regulatory Accountability Act of 2017; SS.1837, Tobacco Tax Equity Act of 2017; S.2100, Tobacco to 21 Act; S.2119, A bill to amend title 38, United States Code, to prohibit smoking in any facility of the Veterans Health Administration, and for other purposes.;S. 3319 Stopping Appealing Flavors in E-Cigarettes for Kids Act; H.J.Res.143 - Making further continuing appropriations for fiscal year 2019, and for other purposes; H.R. 695 Further Additional Continuing Appropriations Act, 2019;
Client expense: $100,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Postal Regulatory Commission, SENATE, Transportation, Dept of (DOT), Veterans Affairs, Dept of (VA), White House Office
2018 · fourth_quarter · Health Issues
Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to the 340B Drug Pricing Program. Monitor legislative and administrative action related to access to medical supplies. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to Tropical Disease Priority Review Voucher Program. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to companion labeling. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the repeal of the Affordable Care Act. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to FDA enforcement of prescription to over-the-counter switches of medicine. Monitor legislative and administrative action related to allowed purchases under the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to opioids. Monitor legislative and administrative action related to implementation of H.R. 3204, Drug Quality and Security Act. S. 404, A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. S. 469, Affordable and Safe Prescription Drug Importation Act. S. 934, FDA Reauthorization Act of 2017. S. 2434, Animal Drug and Animal Generic Drug User Fee Amendments Act of 2018. H.R. 749, Lower Drug Costs through Competition Act. H.R. 1628, American Health Care Act of 2017. H.R. 2009, To amend the Federal Food, Drug, and Cosmetic Act to provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents. H.R. 2118, Medical Device Servicing Safety and Accountability Act. H.R. 2164, Medical Device Safety Act. H.R. 2430, FDA Reauthorization Act of 2017. H.R. 3841, SNAP Vitamin and Mineral Improvement Act of 2017. H.R. 3921, HEALTHY KIDS Act.
Client expense: $1,320,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
2018 · fourth_quarter · Budget/Appropriations
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act; H.R. 6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019; H.R. 2430 the FDA Reauthorization Act (FDARA) of 2017; S.934 FDA Reauthorization Act of 2017;
Client expense: $240,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Raising Awareness of Cystic Fibrosis ***, no specific bill, appropriations for the Department of Health and Human Services, PDUFA, Sunshine, Orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
PL 111-148 - The Patient Protection and Affordable Care Act, implementation, comparative effectiveness research, deficit reduction, PCORI budget resolution, reconciliation, deficit reduction, debt ceiling, appropriations PL 114-255 - 21st Century Cures, implementation H.R. 1625 - Consolidated Appropriations Act of 2018 H.R. 1892 - Bipartisan Budget Act of 2018 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6157 - HHS appropriations and continuing resolution H.R. 695 - Department of Defense Appropriations Act no specific bills: patient engagement, alternative payment models, Part B
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
H.R. 1776/S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 H.R. 749 - Lower Drug Costs Through Competition Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 878/S. 204 - Right to Try Act S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bill, non-interference, 340b, FDASIA implementation, emergency preparedness, counter measures
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills: Innovation, Duchenne Muscular Dystrophy, platform technologies, non-interference
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 878/S. 204 - Right to Try Act H.R. 1231/S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act S. 2852 - Pandemic and All Hazards Preparedness Act S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 6 - SUPPORT for Patients and Communities Act ***no specific bills, importation, supply chain integrity, 304b, biosimilars, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, IPAB
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation Act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act no specific bills - innovation, non-interference, biosimilars, prescription drug access and affordability
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 456 - RACE for Children Act S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act no specific bills, 340B, Innovation, Transparency, Precision Medicine, NIH, Importation, Non-Interference, Vaccines, Biosimilars, Compounding
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies, mobile medical apps, device regulation, Innovation, service, contrast
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
prescription drug abuse and deterrence, non-interference PL 114-255 - 21st Century Cures, implementation Multi-modal analgesics S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 3921 - Healthy Kids Act S. 1827 - Kids Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act S. 3282 - DEA Clearinghouse Act of 2018
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Implementation of the Special Diabetes Program, renewal of the Special Diabetes Program, National Chronic Care Commission PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 3917 - Special Diabetes Program for Indians H.R. 3924 -Special Diabetes Program For Type 1 HR. 3922 - Championing Healthy Kids Act ***, no specific bill, artificial pancreas program, Special Diabetes Program, NIH
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Cost Through Competition Act H.R. 1231/S. 456 - RACE for Children Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bills; user fee reauthorization, non-interference, dormant therapies, drug shortages, prescription drug access and affordability
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill(s), Drug Safety, Prescription Drug Importation, Import Safety, supply chain integrity, biosimilars, PDUFA and associated policies, patent settlements, accelerated approval, break through therapies, compounding, user fee reauthorization, Innovation
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B, comparative effectiveness research, user fee reauthorization, non-interference, IPAB
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act ***, no specific bills, FDA related issues, diagnostics, drug shortages, compounding, pandemic preparedness, health IT, opioid safety, anti-microbial resistance, hazardous drug safety, VA procurement, medical technology regulation, artificial intelligence
Client expense: Not reported · Firm income: $70,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S.771 Improving Access To Affordable Prescription Drugs Act; H.R. 4710, the 340B Protecting Access for the Underserved and Safety-Net Entities Act (340 PAUSE Act)and other issues related to 340B program
Client expense: $870,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, Veterans Affairs, Dept of (VA)
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 469 - Affordable and Safe Prescription Dug Importation H.R. 6 - SUPPORT for Patients and Communities Act ***, no specific bills, PDUFA, antimicrobial resistance, importation, companion diagnostics, user fee sequester, innovation, biomarkers, drug importation, 340b, comparative effectiveness, gift disclosure, oncology, personalized medicine, price transparency, adherence, Vaccines for Children Program
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill(s), Import Safety, drug development policy, drug shortages, supply chain integrity, Innovation, reimportation
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 111-375 - The National Alzheimer's Project Act, implementation Health Outcomes, Planning and Education for Alzheimer's, implementation PL 114-255 - 21st Century Cures, implementation H.R 1628 - American Health Care Act of 2017 H.R. 1676/S. 693 - Palliative Care and Hospice Education and Training Act S. Res. 49 - Alzheimer's as Urgent National Priority H.R. 3263/S. 464 - Independence at Home Act S. 870 - Chronic Care H.R. 2430 - FDA Reauthorization Act of 2017 S. 1827- KIDS Act of 2017 H.R. 4256/S. 2076 - BOLD Act of 2017 no specific bill, Older Americans' Act Reauthorization, care planning, home and community based care, Independence at Home, CDC Centers of Excellence
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition
Client expense: Not reported · Firm income: $30,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
Cervical Cancer Screening, colorectal screening, opioids H.R. 1676/S. 693 - Palliative Care and Hospice Education and Training Act S. 870 - Chronic Care H.R. 2430 - FDA Reauthorization Act of 2017 Affordable Care Act, market stabilization H.R. 820/S. 292 - Childhood Cancer STAR Act H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2018 · fourth_quarter · Health Issues
medical device user fee reauthorization, diagnostics regulation, in vitro diagnostics, influenza preparedness, opioids PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2018 · fourth_quarter · Pharmacy
H.R. 1245/S. 469 The Affordable and Safe Prescription Drug Importation Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 749 Lower Drug Costs Through Competition H.R.2430/S. 934 - FDA Reauthorization Act of 2017 H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 6733 - Know the Cost Act H.R. 6143/ S. 2554 - Patient Right to Know Drug Prices Act H.R. 6144/ S. 2553 - Know the Lowest Price Act H.R. 6641 - True Cost-sharing of Seniors Drugs Transparency (True COST) Act H.R. 5958 - Phair Pricing Act
Client expense: $640,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Over the counter hearing aids, implementation of H.R. 2430 Comments on Internet Protocol Captioned Telephone Services
Client expense: $30,000 · Firm income: Not reported
Government targets: Federal Communications Commission (FCC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)
2018 · first_quarter · Pharmacy
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.
Client expense: $1,040,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · third_quarter · Medical/Disease Research/Clinical Labs
Legislation and policies related to: Pediatric and childrens health research Nursing research Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 2430/S. 934 - FDA Reauthorization Act of 2017 S. 292/H.R. 820 - Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2017 S. 456/H.R. 1231 - Research to Accelerate Cures and Equity (RACE) for Children Act
Client expense: Not reported · Firm income: $23,450
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)
2018 · third_quarter · Health Issues
H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act
Client expense: $223,857 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
HR 2430/S 934 - FDA Reauthorization Act (implementation) -Patient Engagement S. 3000 - Patient Advocacy Transparency Act -Refinement HHS Blueprint - American Patients First -General support and refinement -General opposition to and refinement of HHS memorandum to Medicare Advantage insurers, allowing step therapy for Part B drugs.
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Tobacco
Issues related to lung disease treatment and prevention, and public health; Issues related to tobacco cessation; Issues related to smokefree air; Issues related to Tobacco 21; Issues related to the Tobacco Control Act: Issues related to tobacco smuggling; Issues related to the Affordable Care Act; Issues related to the President's Budget; Issues related to tobacco prevention; H.R.5, Regulatory Accountability Act of 2017; H.R.21, Midnight Rules Relief Act of 2017; H.R.564, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017; H.R.729, Tobacco Excise Tax and Parity Act of 2017; H.R.1136, FDA Deeming Authority Clarification Act of 2017;H.R.1662, To amend title 38, United States Code, to prohibit smoking in any facility of the Veterans Health Administration, and for other purposes.; H.R.1848, Veterans Affairs Medical Scribe Pilot Act of 2017; H.R.2194, Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017; H.R.2430, FDA Reauthorization Act of 2017; H.R.2810, National Defense Authorization Act for Fiscal Year 2018; H.R.3219, Make America Secure Appropriations Act, 2018; H.R.3268, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018; H.R.3354, Interior and Environment, Agriculture and Rural Development, Commerce, Justice, Science, Financial Services and General Government, Homeland Security, Labor, Health and Human Services, Education, State and Foreign Operations, Transportation, Housing and Urban Development, Defense, Military Construction and Veterans Affairs, Legislative Branch, and Energy and Water Development Appropriations Act, 2018; H.R.3362, Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018; H.R.4273, Tobacco to 21 Act; H.Res.796, Providing for consideration of the Senate amendment to the bill (H.R. 1625) to amend the State Department Basic Authorities Act of 1956 to include severe forms of trafficking in persons within the definition of transnational organized crime for purposes of the rewards program of the Department of State, and for other purposes; and providing for proceedings during the period from March 23, 2018, through April 9, 2018.; S.294, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2017; S.934, FDA Reauthorization Act of 2017; S.951, Regulatory Accountability Act of 2017; S.1519, National Defense Authorization Act for Fiscal Year 2018; S.1557, Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2018; S.1603, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018; S.1771, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018; S.1780, Department of State, Foreign Operations, and Related Programs Appropriations Act, 2018; S.1837, Tobacco Tax Equity Act of 2017; S.2100, Tobacco to 21 Act; S.2119, A bill to amend title 38, United States Code, to prohibit smoking in any facility of the Veterans Health Administration, and for other purposes.;H.R.6157 - Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019; S. 3319 Stopping Appealing Flavors in E-Cigarettes for Kids Act; H.R.5895 - Energy and Water, Legislative Branch, and Military Construction and Veterans Affairs Appropriations Act, 2019
Client expense: $90,000 · Firm income: Not reported
Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Postal Regulatory Commission, SENATE, Transportation, Dept of (DOT), Veterans Affairs, Dept of (VA), White House Office
2018 · third_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bil1s, innovation, non-interference, 340B, Hepatitis C, HPV, Shingles, anti-microbial resistance, transparency, Pandemic All Hazards Preparedness Act reauthorization
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Prescription Drug User Fee Act (PDUFA) and associated policies, 340B, Biosimilars, Orphan drugs
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Medical Device User Fee Act - H.R.2430 / S.934 - FDA Reauthorization Act (FDARA) - P.L. 115-52 and related amendments. Potential for BARDA to exercise purchase option under a 2014 contract with Philips Respironics. Healthy aging / frail elderly proposal 3rd Party Service regulation - H.R.2118/Medical Device Servicing Safety and Accountability Act Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Cybersecurity Artificial Intelligence issues relating to medical devices Possible legislation to incentivize/require AEDs in schools H.R.6 - Opioid package and ultrasound nerve blocking as an alternative to opioids Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues
Client expense: $300,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, Veterans Affairs, Dept of (VA)
2018 · third_quarter · Health Issues
H.R. 1776/S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 H.R. 749 - Lower Drug Costs Through Competition Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 878/S. 204 - Right to Try Act S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bill, non-interference, 340b, FDASIA implementation, emergency preparedness, counter measures
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Client expense: $1,330,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2018 · third_quarter · Pharmacy
Issues related to P.L. 115-52 (H.R. 2430/S. 934) FDA Reauthorization Act of 2017 (Prescription Drug User Fee Act VI); H.R. 1245/S. 469 Affordable and Safe Prescription Drug Importation Act; H.R. 1776/S. 771 Improving Access to Affordable Prescription Drugs Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE