SAFE DOSES Act

Budget 2013 Defense Appropriations H.R. 4223

Client expense: Not reported · Firm income: $20,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE

Budget 2013 Defense Appropriations H.R. 4223

Client expense: Not reported · Firm income: $20,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE

- Issues regarding the theft of medical products. - S 1002, "SAFE DOSES Act", regarding all provisions. - HR 4223, "Safe Doses Act", regarding all provisions.

Client expense: $880,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

H.R. 228, the Traffic Stops Along the Border Statistics Study Act, would require the U.S. Attorney General to collect race and other data on traffic stops made by State and local law enforcement officers; H.R. 324, legislation which would grant statutory arrest authority to law enforcement officers employed by the U.S. Department of Defense; H.R. 365/S. 657, the "National Blue Alert," legislation creating an alert system for law enforcement officers killed or seriously injured in the line of duty; H.R. 498, the "State and Local Law Enforcement Hatch Act Reform Act," which would amend the Hatch Act to allow local and State law enforcement officers to be candidates for the office of Sheriff and permit Sheriffs to engage in political activity; H.R. 815, the Justice for Public Servants Act, would expand the death penalty by adding the murder or attempted murder of a law enforcement officer, Member of Congress or Congressional employee as aggravating factors in death penalty cases; H.R. 1416/S. 755, the Crime Victim Restitution and Court Fee Intercept Act, would provide federal authorization for the U.S. Department of Treasury to intercept tax refunds to pay overdue court-ordered financial obligations, including court fines, fees and restitution; H.R. 1505/H.R. 2578, the National Security and Federal Lands Protection Act, which would give the U.S. Border Patrol the authority to fully patrol Federally own lands; H.R. 3416/S. 1483, the Incorporation Transparency and Law Enforcement Assistance Act, would help law enforcement combat the misuse of U.S. corporations by requiring States to obtain beneficial ownership information for corporations and limited liability companies formed under State law; H.R. 4310/S. 3254, the "National Defense Authorization Act for Fiscal Year 2013"; H.R. 1789, the State and Local Law Enforcement Discipline, Accountability and Due Process Act, which would protect the due process rights of officers during internal investigations; H.R. 1981, the Protecting Children From Internet Pornographers Act, which would improve the ability of law enforcement to combat trafficking in child pornography; H.R. 2168/S. 1212, the Geolocational Privacy and Surveillance Act, which would significantly increase the requirements that must be met by law enforcemnt before they could request geolocation information on potential vicims or suspects; H.R. 2492/S. 1947, the "Animal Fight Spectator Prohibition Act," which would make it a crime to attend or bring a minor to any event or venture at which animals are forced to fight; H.R. 3261, the Stop Online Piracy Act, which would strengthen the ability of the United States to take action against foreign rogue websites that traffic in counterfeit and pirated products; H.R. 3416/S. 1483, the "Incorporation Transparency and Law Enforcement Assistance Act," which would give law enforcement access to the beneficial ownership information for corporations and limited liability companies (LLCs) formed under State laws; H.R. 4223/S. 1002, the "Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety (SAFE DOSES) Act," which would increase the penalties for the theft and resale of medical products; H.R. 3618/S. 1670, the End Racial Profiling Act, which would define racial profiling as any consideration of race, national origin or ethnic origin to initiate a traffic stop or vehicle search absent an eyewitness description and requires the collection of race and other data by State and local law enforcement during routine investigatory activities; H.R. 6063, the Child Protection Act, enhances the ability of law enforcement to combat child pornography by increasing the penalties of possessing child pornography and reauthorizing the Internet Crimes Against Children task forces; H.R. 6628/S. 3250, the "Sexual Assault Forensic Evidence Registry (SAFER) Act," which would assist State and local law enforcement agencies reduce the laboratory and storage rape kit backlogs by funding audits of untested sexual assault evidence; S. 306, the National Criminal Justice Commission Act," which would create a National Commission to examine the U.S. criminal justice systems at the State and Federal level; S. 513, the Saving Kids from Dangerous Drugs Act, would increase penalties on those who tailor-market illegal drugs to entice children to purchase them; S. 890, the Fighting Fraud to Protect Taxpayers Act, would redirect money in the Working Capital fund toward additional fraud enforcement efforts and give the US Secret Service the permanent authority to conduct undercover operations; S. 968 , the Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act (PROTECT IP) Act, which would strengthen the ability of the United States to take action against foreign rogue websites that traffic in counterfeit and pirated products; S. 1925, the "Violence Against Women Reauthorization Act," specifically on language to expand the U Visa program; S. 3187, the "Food and Drug Administration Safety and Innovation Act," specifically on an amenment to reschedule the drug hydrocodone; and Legislation which would normalize relations with Cuba until that nation ceases to be a safe harbor for cop-killers and other fugitives.

Client expense: $55,000 · Firm income: Not reported

Government targets: Bureau of Alcohol Tobacco Firearms & Explosives, Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), SENATE, White House Office

H.R. 4223 the "Safe Doses Act"; H.R. 3668 the "Counterfeit Drug Penalty Enhancement Act of 2011"; and H.R. 4216 the "Foreign Counterfeit Prevention Act.", all parts Combat Meth epidemic Act of 2005, sections pertaining to electronic reporting and stop sale Meth Lab Elimination Act of 2010, a draft by Sen. Wyden, all parts relating to pseudoephedrine

Client expense: $1,150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines

Client expense: $1,370,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Pseudoephedrine Theft of medical products S.1002-SAFE DOSES Act H.R.4223-SAFE DOSES Act

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Modernizing criminal laws concerning theft of medical products S.1002-SAFE DOSES Act H.R.4223-SAFE DOSES Act

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Theft of medical products S.1002-SAFE DOSES Act H.R.4223-SAFE DOSES Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues regarding implementation of Public Law 111-148 "Patient Protection and Affordable Care Act" including the Independent Payment Advisory Board; "HR 4223 "Strenghthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2012" or "Safe Doses Act" - all provisions; issues related to the continued over-the-counter availability of allergy, cough and cold medicines that contain pseudoephedrine; HR 2405 and S 1855 "Pandemic and All Hazards Preparation Act Reauthorization of 2011" - all provisions; HR 3627 and S 1884 "School Access to Emergency Epinephrine Act" - all provisions; education and awareness of pandemic and biodefence funding in FY2012 and related international intellectual property issues; and education and awareness of dengue.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page Importation of prescription drugs (S.319/H.R. 147) NASPER reauthorization (H.R. 866) Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297) Drug Abuse (S. 507) Drug Shortages (S. 296/H.R. 2245/H.R. 3839/PL 112-144/H.R. 5853/H.R. 5651) Rx Pedigree (H.R. 3026/PL 112-144) Cargo/Product Theft (S. 1002/H.R. 4223) Prescription Drug Monitoring Program (H.R. 2254/H.R. 4292/PL 112-144) Counterfeit Drugs (S. 1886/H.R. 3668/PL 112-144) ***, no specific bills, supply chain integrity, prescription drug abuse

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Rx Pedigree (H.R. 3026/PL 112-144); NASPER Reauthorization (H.R. 866); Prescription Drug Monitoring Programs (S. 2254/H.R. 4292/PL 112-144); Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297); Drug Abuse (S. 507); Drug Shortages (S. 296/HR 2245/HR 3839/ PL 112-144/HR 5853/HR 5651); Cargo/Product Theft (S. 1002/H.R. 4223; PL 112-204); Counterfeit Drugs (S. 1886/H.R. 3668/PL 112-144)

Client expense: $228,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

General issues regarding implementation of Public Law 111-148 "Patient Protection and Affordable Care Act including issues related to the Independent Payment Advisory Board; "HR4223 "Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2012" or "SAFE DOSES Act" - all provisions; issues related to the continued over-the-counter availability of allergy, cough and cold medicines that contain pseudoephedrine; HR2405 and S1855 "Pandemic and All Hazards Preparation Act Reauthorization of 2011" - all provisions; HR3627 and S1884 "School Access to Emergency Epinephrine Act" - all provisions; education and awareness of pandemic and biodefense funding in FY2012 and related international intellectual property issues; and education and awareness of dengue.

Client expense: $1,590,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 4223/S 1002 - the "SAFE DOSES Act," all provisions regarding embezzling, stealing, obtaining by fraud or deception, or knowingly and unlawfully taking, carrying away, or concealing a medical prduct that has not yet been made available for retail purchase by a consumer.

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 228, the Traffic Stops Along the Border Statistics Study Act, would require the U.S. Attorney General to collect race and other data on traffic stops made by State and local law enforcement officers; H.R. 324, legislation which would grant statutory arrest authority to law enforcement officers employed by the U.S. Department of Defense; H.R. 365/S. 657, the "National Blue Alert," legislation creating an alert system for law enforcement officers killed or seriously injured in the line of duty; H.R. 498, the "State and Local Law Enforcement Hatch Act Reform Act," which would amend the Hatch Act to allow local and State law enforcement officers to be candidates for the office of Sheriff and permit Sheriffs to engage in political activity; H.R. 815, the Justice for Public Servants Act, would expand the death penalty by adding the murder or attempted murder of a law enforcement officer, Member of Congress or Congressional employee as aggravating factors in death penalty cases; H.R. 1416, the Crime Victim Restitution and Court Fee Intercept Act, would provide federal authorization for the U.S. Department of Treasury to intercept tax refunds to pay overdue court-ordered financial obligations, including court fines, fees and restitution; H.R. 1505/H.R. 2578, the National Security and Federal Lands Protection Act, which would give the U.S. Border Patrol the authority to fully patrol Federally own lands; H.R. 3416/S. 1483, the Incorporation Transparency and Law Enforcement Assistance Act, would help law enforcement combat the misuse of U.S. corporations by requiring States to obtain beneficial ownership information for corporations and limited liability companies formed under State law; H.R. 4310/S. 3254, the "National Defense Authorization Act for Fiscal Year 2013;"; H.R. 1789, the State and Local Law Enforcement Discipline, Accountability and Due Process Act,which would protect the due process rights of officers during internal investigations; H.R. 1981, the Protecting Children From Internet Pornographers Act, which would improve the ability of law enforcement to combat trafficking in child pornography; H.R. 2168/S. 1212, the Geolocational Privacy and Surveillance Act, which would significantly increase the requirements that must be met by law enforcemnt before thy could request geolocation information on potential vicims or suspects; H.R. 2492/S. 1947, the "Animal Fight Spectator Prohibition Act," which would make it a crime to attend or bring a minor to any event or venture at which animals are forced to fight; H.R. 3261, the Stop Online Piracy Act, which would strengthen the ability of the United States to take action against foreign rogue websites that traffic in counterfeit and pirated products; H.R. 4223/S. 1002, the "Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety (SAFE DOSES) Act," which would increase the penalties for the theft and resale of medical products; H.R. 3618/S. 1670, the End Racial Profiling Act, which would define racial profiling as any consideration of race, national origin or ethnic origin to initiate a traffic stop or vehicle search absent an eyewitness description and requires the collection of race and other data by State and local law enforcement during routine investigatory activities; H.R. 6063, the Child Protection Act, enhances the ability of law enforcement to combat child pornography by increasing the penalties of possessing child pornography and reauthorizing the Internet Crimes Against Children task forces; S. 306, the National Criminal Justice Commission Act," which would create a National Commission to examine the U.S. criminal justice systems at the State and Federal level; S. 513, the Saving Kids from Dangerous Drugs Act, would increase penalties on those who tailor-market illegal drugs to entice children to purchase them; S. 755, the Crime Victim Restitution and Court Fee Intercept Act, would provide federal authorization for the U.S. Department of Treasury to intercept tax refunds to pay overdue court-ordered financial obligations, including court fines, fees and restitution; S. 890, the Fighting Fraud to Protect Taxpayers Act, would redirect money in the Working Capital fund toward additional fraud enforcement efforts and give the US Secret Service the permanent authority to conduct undercover operations; S. 968 , the Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act (PROTECT IP) Act, which would strengthen the ability of the United States to take action against foreign rogue websites that traffic in counterfeit and pirated products; S. 1925, the "Violence Against Women Reauthorization Act," specifically on language to expand the U Visa program; S. 3187, the "Food and Drug Administration Safety and Innovation Act," specifically on an amenment to reschedule the drug hydrocodone; and Legislation which would normalize relations with Cuba until that nation ceases to be a safe harbor for cop-killers and other fugitives.

Client expense: $55,000 · Firm income: Not reported

Government targets: Bureau of Alcohol Tobacco Firearms & Explosives, Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), SENATE, White House Office

Budget Defense appropriations H.R. 4223

Client expense: Not reported · Firm income: $20,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE

Budget Defense appropriations H.R. 4223

Client expense: Not reported · Firm income: $20,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE

H.R. 4223 the "Safe Doses Act"; H.R. 3668 the "Counterfeit Drug Penalty Enhancement Act of 2011"; and H.R. 4216 the "Foreign Counterfeit Prevention Act.", all parts, H.R 2245, the Preserving Access to Life Saving Medications Act, Drug Shortage Issues, those issues related to FDA, PDUFA IV and Energy & Commerce hearings on 9/23/11 Combat Meth epidemic Act of 2005, sections pertaining to electronic reporting and stop sale Meth Lab Elimination Act of 2010, a draft by Sen. Wyden, all parts relating to pseudoephedrine

Client expense: $1,290,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Issues regarding the theft of medical products. - S 1002, "SAFE DOSES Act", regarding all provisions. - HR 4223, "Safe Doses Act", regarding all provisions.

Client expense: $1,420,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Pseudoephedrine Theft of medical products S.1002-SAFE DOSES Act H.R.4223-SAFE DOSES Act

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Modernizing criminal laws concerning theft of medical products S.1002-SAFE DOSES Act H.R.4223-SAFE DOSES Act

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

**see addendum page Importation of prescription drugs (S.319/H.R. 147) NASPER reauthorization (H.R. 866) Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297) Drug Abuse (S. 507) Drug Shortages (S. 296/H.R. 2245/H.R. 3839/S.3187/H.R. 5853/H.R. 5651) Rx Pedigree (H.R. 3026/S. 3187) Cargo/Product Theft (S. 1002/H.R. 4223) Prescription Drug Monitoring Program (H.R. 2254/H.R. 4292/S. 3187) Counterfeit Drugs (S. 1886/H.R. 3668/S. 3187) ***, no specific bills, supply chain integrity, prescription drug abuse

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Theft of medical products S.1002-SAFE DOSES Act H.R.4223-SAFE DOSES Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 810, Great Ape Protection and Cost Savings Act of 2011: Provisions related to pre-clinical testing S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

Client expense: $4,140,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Over-criminalization of Conduct and Over-federalization of Criminal law; Criminal Justice and Forensic Science Reform Act (S. 132) - all provisions; H.R. 3261, Stop Online Piracy Act (SOPA); H.R. 4171 and S. 2062, Freedom from Over-Criminalization and Unjust Seizures Act of 2012 (FOCUS Act); Due Process Guarantee Act of 2011 (S. 2003); Public Officials Accountability Act (S. 995) - all provisions; Foreign Corrupt Practices Act - all provisions; H.R. 4223 and S. 1002, Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2011 (SAFE Doses Act); H.R. 4271 and S. 1925, Violence Against Women Reauthorization Act of 2012 (VAWA); S. 1923, Internet Abuse, Stalking, and Domestic Violence Prevention Act of 2011; Cyber Security bills (H.R. 3523, H.R. 3674, S. 2105, S. 2111, S. 2151); Synthetic Drug Control Act (H.R. 1254 and S. 605) - all provisions; 2013 National Defense Authorization Act (H.R. 4310, S. 2467) - detention provisions; Fairness in Disclosure of Evidence Act (S. 2197) - all provisions; Forensic Science and Standards Act (S. 3378) - all provisions; Adam Walsh Reauthorization Act (H.R. 2870) - all provisions; FY 2013 Commerce, Justice, Science, and Related Agencies Appropriations Act - funding for John R. Justice Prosecutors and Defenders Incentive Act; Incorporation Transparency and Law Enforcement Assistance Act (S. 1483).

Client expense: $50,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Securities & Exchange Commission (SEC), White House Office

Drug Pedigree; Drug Shortages; Generic Drug Labeling; Generic Drugs; HR3026 Safeguarding America's Pharmaceutical Act of 2011; HR4223 Safe Doses Act; S1002 Safe Doses Act; HR5651 FDA Reform Act of 2012; S3187 FDA Safety and Innovation Act; HR6433 FDA User Fee Corrections Act of 2012; HR3590 Patient Protection and Affordable Health Care Act provisions relating to biosimilar medicines; S2295 Patient Safety and Generic Labeling Improvement Act

Client expense: $280,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General issues regarding implementation of Public Law 111-148 "Patient Protection and Affordable Care Act" including the Independent Payment Advisory Board (IBAP); awareness & issues related to diabetes and patient access to diabetes care; general issues related to prescription drug safety; H.R. 2529 "Restoring Access to Medication Act" - all provisions; H.R. 3627 and S. 1884 "School Access to Emergency Epinephrine Act" - all provisions; issues related to efforts to move pseudoephedrine products to prescription drug status; education and awareness of influenze pandemic and biodefense funding in FY2012 funding bills; education and awareness and general issues related to the reauthorization of the Pandemic and All Hazards Preparation Act; H.R. 2405 and S. 1855 education and awareness of Dengue; H.R. 4223 "Strengthening and Focusing Enforcement to deter Organized Stealing and Enhance Safety Act of 2012" or "Safe Doses Act"; H. Res. 295 "Promoting increased awareness, diagnosis and treatment of atrial fibrillation to address the high morbidity and mortality rates and to prevent avoidable hospitalizations associated with the disease; H.R. 436 "Healthcare Cost Reduction Act of 2012"; awareness and issues related to diabetes and patient access to diabetes care.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

Client expense: $890,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Rx Pedigree (H.R. 3026/S. 3187); NASPER Reauthorization (H.R. 866); Prescription Drug Monitoring Programs (S. 2254/H.R. 4292/S.3187); Pill Mill Crackdown Act (H.R. 1065/S. 1760/S. 2297); Drug Abuse (S. 507); Drug Shortages (S. 296/ H.R. 2245/H.R. 3839/S. 3187/H.R. 5853/H.R. 5651); Cargo/Product Theft (S. 1002/H.R. 4223); Counterfeit Drugs (S. 1886/H.R. 3668/S. 3187)

Client expense: $222,819 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

General issues related to prescription drug safety and the importation of prescription drugs. Opposed amendment to PDUFA, S. 3187, that would allow unsafe importation of drugs. General issues regarding implementation of Public Law 111-148, Patient Protection and Affordable Care Act - including issues related to the Independent Payment Advisory Board and efforts to repeal provisions that prohibit individuals from using Health Savings Accounts or Flexible Spending Accounts to purchase Over-The-Counter medical products, including such provisions in H.R.2529, Restoring Access to Medication Act and H.R.436 - Health Care Cost Reduction Act of 2012. Awareness and issues related to diabetes and patient access to diabetes care. H.R.4223, Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2012 or "SAFE DOSES Act" - all provisions. Issues related to the continued over-the-counter availability of allergy, cough and cold medicines that contain pseudoephedrine. H.R. 2405 and S.1855, Pandemic and All Hazards Preparation Act Reauthorization of 2011 - all provisions. H.R. 3627 and S.1884, School Access to Emergency Epinephrine Act - all provisions. Education and awareness of influenza pandemic and biodefense funding in FY2012 and related international intellectual property issues. Education and awareness of Dengue. All provisions of H. Res. 295, Promoting increased awareness, diagnosis, and treatment of atrial fibrillation to address the high morbidity and mortality rates and to prevent avoidable hospitalizations associated with this disease.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1002 SAFE DOSES Act and HR 4223 Safe Doses Act (Modernizing criminal laws concerning theft of medical products)

Client expense: $400,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, White House Office

General issues regarding implementation of Public Law 111-148 "Patient Protection and Affordable Care Act" including issues related to the Independent Payment Advisory Board, and efforts to repeal provisions that prohibit individuals from using Health Savings Accounts or Flexible Spending Accounts to purchase Over-The-Counter medical products, including such provisions in HR2529 "Restoring Access to Medication Act" and HR436 "Health Care Cost Reduction Act of 2012"; awareness & issues related to diabetes and patient access to diabetes care; HR4223 "Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2012" or "SAFE DOSES Act" - all provisions; issues related to the continued over-the-counter availability of allergy, cough and cold medicines that contain pseudoephedrine; HR2405 and S1855 "Pandemic and All Hazards Preparation Act Reauthorization of 2011" - all provisions; HR3627 and S1884 "School Access to Emergency Epinephrine Act" - all provisions; education and awareness of influenza pandemic and biodefense funding in FY2012 and related international intellectual property issues; education and awareness of dengue; and all provisions of H. Res. 295 "Promoting increased awareness, diagnosis, and treatment of atrial fibrillation to address the high morbidity and mortality rates and to prevent avoidable hospitalizations associated with this disease."

Client expense: $710,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1002 SAFE DOSES Act and H.R. 4223 Safe Doses Act (Modernizing criminal laws concerning theft of medical products)

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE

Budget Defense appropriations H.R. 4223

Client expense: Not reported · Firm income: $20,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE

Budget Defense appropriations H.R. 4223

Client expense: Not reported · Firm income: $20,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE

Pseudoephedrine Theft of medical products S.1002-SAFE DOSES Act H.R.4223-SAFE DOSES Act

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

HR 432/ S136 Ban Poisonous Additives Act of 2011: A bill to ban the use of Bisphenol-A in food containers, and for other purposes; (All provisions pertaining to the ban of food contact applications and the science used to support the ban on Bisphenol-A containing products.) HR 4223 The "Safe Doses Act"; (All provisions of the bill.) HR 3668 The "Counterfeit Drug Penalty Enhancement Act of 2011"; (All parts.) HR 4216 The "Foreign Counterfeit Prevention Act"; (All parts.) Draft Discussion of FDA User Fees; (All parts) S 365 Balanced Budget Control Act of 2011; (Sections pertaining to healthcare expenditures, Medicare Part D drug benefits.) Combat Meth Epidemic Act of 2005; (Sections pertaining to electronic reporting and stop sale.) HR 2245 the Preserving Access to Life Saving Medications Act; (Provisions relating drug shortage issues, those issues related to FDA, PDUFA IV and Energy & Commerce hearings on 9/23/11.) HR 965/S 1211 The Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases; (Title II. General provisions of the bill.) HR 436 Health Care Cost Reduction Act of 2012; (Provisions related to medical device taxes.) Safe Injection Practices (no bill number); (Provisions related to safer injection practices.)

Client expense: $1,450,321 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 4223 The "Safe Doses Act"; (All parts.) HR 3668 The "Counterfeit Drug Penalty Enhancement Act of 2011"; (All provisions.) HR 4216 The "Foreign Counterfeit Prevention Act"; (All provisions.) Draft Discussion on FDA User Fees; (All provisions.) Combat Meth Epidemic Act of 2005; (Sections pertaining to electronic report and stop sale.) HR 2245 The Preserving Access to Life Saving Medications Act; (Drug shortage issues, those issues related to FDA, PDUFA IV and Energy & Commerce hearings on 9/23/11.) Meth Lab Elimination Act of 2010, a draft by Senator Wyden; (All parts relating to pseudoephedrine.) Maintaining Consumer Access to Cough Medicine Act of 2011, a draft; (All parts relating to DXM.) HR 525 Veterinary Public Health Amendments Act: An act to amend the Public Health Service Act to enhance and increase the number of veterinarians trained in veterinary public health.) HR 1406 Fairness to Pet Owners Act 2011; (General provisions requiring veterinary prescribing.)

Client expense: $1,450,321 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Excellence in Mental Health Act (S. 2257/H.R. 5989), all provisions related to expanding access to mental health and addictions care by supporting FQCBHCs in treating all individuals regardless of their ability to pay, with a comprehensive array of outpatient behavioral health services Mental Health in Schools Act of 2011 (H.R. 751), all provisions related to revising community children and violence program to assist local communities and schools in applying a public health approach to mental health services Mental Health First Aid Higher Education Act of 2012 (S. 3325/H.R. 5996), all provisions related to authorizing a demonstration program to train college faculty and staff in Mental Health First Aid, a community education program that helps people identify, understand, and respond to signs of mental illnesses and addictions and deal with psychiatric crises 21st Century Language Act (S. 2367), all provisions related to removing references to the word "lunatic" from rules of construction of the U.S. Code and banking law provisions Safe Doses Act (H.R. 4223), all provisions related to prohibiting theft of a pre-retail medical products, including drugs, medical devices and infant formula and prohibiting alteration of the labels of pre-retail medical products, transport of stolen or counterfeit medical products and purchase or distribution of expired medical products with the intent to defraud Behavioral Health Information Technology Act (S. 539/H.R. 6043), all provisions related to expanding federal incentive payments for the adoption and meaningful use of electronic health records to behavioral health providers and facilities Childrens Mental Health Accessibility Act of 2012 (S. 3289), all provisions related to expanding Medicaid 1915(c) waiver and removing mentally retarded from statute

Client expense: $32,495 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Over-criminalization of Conduct and Over-federalization of Criminal law; Criminal Justice and Forensic Science Reform Act (S. 132) - all provisions; H.R. 3261, Stop Online Piracy Act (SOPA); H.R. 4171 and S. 2062, Freedom from Over-Criminalization and Unjust Seizures Act of 2012 (FOCUS Act); Due Process Guarantee Act of 2011 (S. 2003); Public Officials Accountability Act (S. 995) - all provisions; Foreign Corrupt Practices Act - all provisions; H.R. 4223 and S. 1002, Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2011 (SAFE Doses Act); H.R. 4271 and S. 1925, Violence Against Women Reauthorization Act of 2012 (VAWA); S. 1923, Internet Abuse, Stalking, and Domestic Violence Prevention Act of 2011; Cyber Security bills (H.R. 3523, H.R. 3674, S. 2105, S. 2111, S. 2151); Synthetic Drug Control Act (H.R. 1254 and S. 605) - all provisions; 2013 National Defense Authorization Act (H.R. 4310, S. 2467) - detention provsisions; Solitary Confinement; H.R. 3361, Utilizing DNA Technology to Solve Cold Cases Act.

Client expense: $50,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, Securities & Exchange Commission (SEC), White House Office

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

Client expense: $4,840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

- Issues regarding the theft of medical products. - S 1002, "SAFE DOSES Act", regarding all provisions. - HR 4223, "Safe Doses Act", regarding all provisions.

Client expense: $1,200,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Modernizing criminal laws concerning theft of medical products S.1002-SAFE DOSES Act H.R.4223-SAFE DOSES Act

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Theft of medical products S.1002-SAFE DOSES Act H.R.4223-SAFE DOSES Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE