To amend the Controlled Substances Act to address the use of intrathecal pumps.

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 3018 and S. 3274, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $6,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 3018 and S. 3274, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

DEA Issues relating to the Controlled Substances Act, HR 3018

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, SENATE

House, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. S.3686, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2011. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Patient Protection and Affordable Care Act (P.L. 111-148). Assist in appropriations efforts and monitor federal and legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60).

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, Navy, Dept of, SENATE

House, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. S.3686, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2011. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Patient Protection and Affordable Care Act (P.L. 111-148). Assist in appropriations efforts and monitor federal and legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60).

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, Navy, Dept of, SENATE

House, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. S.3686, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2011. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Patient Protection and Affordable Care Act (P.L. 111-148). Assist in appropriations efforts and monitor federal and legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60).

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, Navy, Dept of, SENATE

House, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. S.3686, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2011. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Patient Protection and Affordable Care Act (P.L. 111-148). Assist in appropriations efforts and monitor federal and legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60).

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, Navy, Dept of, SENATE

FY11 Appropriations with a focus on student aid, research funding and humanities. HR 3018 Continuing Resolution for FY11. President's Budget for FY12 (regarding research and education funding). S3800 Department of Defense Appropriations Act, 2011 Implementation of ARRA, regarding research and education funding.S3686 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2011. S3636 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2011 S3635 Energy and Water Development and Related Agencies Appropriations Ac, 2011 S3686 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2011 HR5850, 3644 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2011

Client expense: $120,000 · Firm income: Not reported

Government targets: Education, Dept of, HOUSE OF REPRESENTATIVES, SENATE

HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 3018 and S. 3274, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $6,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation introduced yet. H.R. 3018 and S. 3274, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 3018 and S. 3274, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. H.R. 3590, Patient Protection and Affordable Care Act. (P.L. 111-148) H.R. 4872, Health Care and Education Reconciliation Act of 2010. (P.L. 111-152) H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Assist in appropriations efforts and monitor all legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60).

Client expense: Not reported · Firm income: $100,000

House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. H.R. 3590, Patient Protection and Affordable Care Act. (P.L. 111-148) H.R. 4872, Health Care and Education Reconciliation Act of 2010. (P.L. 111-152) H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Assist in appropriations efforts and monitor all legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60).

Client expense: Not reported · Firm income: $100,000

House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. H.R. 3590, Patient Protection and Affordable Care Act. (P.L. 111-148) H.R. 4872, Health Care and Education Reconciliation Act of 2010. (P.L. 111-152) H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Assist in appropriations efforts and monitor all legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60).

Client expense: Not reported · Firm income: $100,000

House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. H.R. 3590, Patient Protection and Affordable Care Act. (P.L. 111-148) H.R. 4872, Health Care and Education Reconciliation Act of 2010. (P.L. 111-152) H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Assist in appropriations efforts and monitor all legislative activity related to health care and reauthorization of National All Schedules Prescription Electronic Reporting Act (NASPER) (P.L. 109-60).

Client expense: Not reported · Firm income: $100,000

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation introduced yet. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation introduced yet. H.R. 3018 and S. 3274, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. H.R. 3590, Patient Protection and Affordable Care Act. (P.L. 111-148) H.R. 4872, Health Care and Education Reconciliation Act of 2010. (P.L. 111-152) H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. H.R. 3590, Patient Protection and Affordable Care Act. (P.L. 111-148) H.R. 4872, Health Care and Education Reconciliation Act of 2010. (P.L. 111-152) H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. H.R. 3590, Patient Protection and Affordable Care Act. (P.L. 111-148) H.R. 4872, Health Care and Education Reconciliation Act of 2010. (P.L. 111-152) H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. Senate Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft Legislation, FY11. H.R. 3590, Patient Protection and Affordable Care Act. (P.L. 111-148) H.R. 4872, Health Care and Education Reconciliation Act of 2010. (P.L. 111-152) H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

DEA Issues - Controlled Substances Act related to intrathecal devices...H.R. 3018

Client expense: Not reported · 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

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation introduced yet. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation introduced yet. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number FDA2009D0181) Draft Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability (Docket Number FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number FDA1977N0013) (formerly Docket No. 1977N0094L) Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph (Docket Number FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number FDA2006N0238) (formerly Docket No. 2006N0062) Expanded Access to Investigational Drugs for Treatment Use (Docket Number FDA2006N0237) (formerly Docket No. 2006N0061) Charging for Investigational Drugs Under an Investigational New Drug Application (Docket Number FDA2009N0247) Food and Drug Administration Transparency Task Force; Reopening of Comment Period (Docket Number DEA321) Identification of Institution-based Individual Practitioners (Docket Number FDA2009N0374) Educating the Public About Removal of Essential-Use Designation for Epinephrine; Public Workshop; Request for Comments (Docket Number FDA2009N0441) Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Docket Number FDA-2009-N-0138) Liver Injury Related to the Use of Acetaminophen; Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee (DEA Information Collection 1117-0046) Self-Certification, Training and Logbooks for Regulated Sellers of Scheduled Listed Chemical Products (Docket Number FDA2008N0424) Postmarketing Safety Reporting for Combination Products (Docket Number FDA2009N0664) Risk Communication Advisory Committee; Notice of Meeting Concept - Medication Adherence Concept - Pharmacogenomics Concept - Oppose Liberalizing Prescription Drug Importation Concept - Agent of the Prescriber

Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (P.L. 111-117). H.R. 3018, To Amend the Controlled Substances Act to Address the Use of Intrathecal Pumps. H.R. 3962, Affordable Health Care for America Act. H.R. 3590, Patient Protection and Affordable Care Act. H.R. 3200, America's Affordable Health Choices Act of 2009. S. 1796, America's Healthy Future Act of 2009. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (P.L. 111-117). H.R. 3018, To Amend the Controlled Substances Act to Address the Use of Intrathecal Pumps. H.R. 3962, Affordable Health Care for America Act. H.R. 3590, Patient Protection and Affordable Care Act. H.R. 3200, America's Affordable Health Choices Act of 2009. S. 1796, America's Healthy Future Act of 2009. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (P.L. 111-117). H.R. 3018, To Amend the Controlled Substances Act to Address the Use of Intrathecal Pumps. H.R. 3962, Affordable Health Care for America Act. H.R. 3590, Patient Protection and Affordable Care Act. H.R. 3200, America's Affordable Health Choices Act of 2009. S. 1796, America's Healthy Future Act of 2009. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (P.L. 111-117). H.R. 3018, To Amend the Controlled Substances Act to Address the Use of Intrathecal Pumps. H.R. 3962, Affordable Health Care for America Act. H.R. 3590, Patient Protection and Affordable Care Act. H.R. 3200, America's Affordable Health Choices Act of 2009. S. 1796, America's Healthy Future Act of 2009. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation introduced yet. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation introduced yet. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the compounding pharmacies, in particular relating to FDA action to ban the hormone estriol from compounded estrogens. No specific legislation has been introduced yet. Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation has been introduced yet. H.R. 3018, To amend the Controlled Substances Act to address the use of intrathecal pumps. Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Client expense: Not reported · Firm income: $11,250

H.R. 3293, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2010. Senate Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft, FY10. H.R. 3018, To Amend the Controlled Substances Act to Address the Use of Intrathecal Pumps. H.R. 3200, America's Affordable Health Choices Act of 2009. Senate Draft, Americas Healthy Future Act of 2009. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3293, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2010. Senate Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft, FY10. H.R. 3018, To Amend the Controlled Substances Act to Address the Use of Intrathecal Pumps. H.R. 3200, America's Affordable Health Choices Act of 2009. Senate Draft, Americas Healthy Future Act of 2009. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3293, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2010. Senate Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft, FY10. H.R. 3018, To Amend the Controlled Substances Act to Address the Use of Intrathecal Pumps. H.R. 3200, America's Affordable Health Choices Act of 2009. Senate Draft, Americas Healthy Future Act of 2009. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3293, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2010. Senate Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Draft, FY10. H.R. 3018, To Amend the Controlled Substances Act to Address the Use of Intrathecal Pumps. H.R. 3200, America's Affordable Health Choices Act of 2009. Senate Draft, Americas Healthy Future Act of 2009. Assist in appropriations efforts and monitor all legislative activity related to health care.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY2010 Foreign Appropriations (HR 3018) (S.1434), Interoperable Communications related to Mexico, Georgia, and Central America; Interoperability funding for Phillipines, Mexico (P.L. 111-8),

Client expense: $1,250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor, Health & Human Services, Education Appropriations (HR 3293): Health IT, Education; Defense Bill (HR 3326); FY 2010 DOD Appropriations (HR 3326) Interoperable Communications; FY2010 Foreign Appropriations (HR 3018) (S.1434), Interoperable Communications related to Mexico, Georgia, and Central America; Interoperability funding for Phillipines, Mexico (P.L. 111-8); Integrated Wireless Network, grant programs; Tactical Communications and Border Interoperability pilot funding (P.L. 110-329, S.1); Integrated Wireless Network, grant programs (S.3182); Border Issues, grant programs, grant language (S.1) (P.L. 110-329); US Capitol Police Radio Upgrades

Client expense: $1,250,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR1204 - The Community Pharmacy Fairness Act of 2009 S80 - Pharmaceutical Market Access Act of 2009 HR1298/S525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR163 - Prescription Drug Affordability Act HR2400 - Strategies to Address Antimicrobial Resistance Act HR1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all Pharmacy-Based Communications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy includes: medication guides; patients package inserts; and consumer medication information (Docket Number FDA2009D0181) Draft Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products;Availability (Docket Number FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number FDA1977N0013) (formerly Docket No. 1977N0094L) Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph (Docket Number FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number FDA2006N0238) (formerly Docket No. 2006N0062) Expanded Access to Investigational Drugs for Treatment Use (Docket Number FDA2006N0237) (formerly Docket No. 2006N0061) Charging for Investigational Drugs Under an Investigational New Drug Application (Docket Number FDA2009N0247) Food and Drug Administration Transparency Task Force; Reopening of Comment Period (Docket Number DEA321a) Identification of Institution-based Individual Practitioners (Docket Number FDA2009N0374) Educating the Public About Removal of Essential-Use Designation for Epinephrine; Public Workshop; Request for Comments (Docket Number FDA2009N0441) Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Docket Number FDA-2009-N-0138) Liver Injury Related to the Use of Acetaminophen; Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee (DEA Information Collection 1117-0046) Self-Certification, Training and Logbooks for Regulated Sellers of Scheduled Listed Chemical Products Concept - Oppose Liberalizing Prescription Drug Importation Concept - Misuse of Antibiotics in Agriculture