| Report | Content of Specific Issue field |
|---|---|
 | Issues pertaining to Prescription Drug Monitoring. Public Health. Monitor legislation and oversight on compounding pharmacies. |
| S 320 - Medical Innovation Act - NIH funding |
| Federal legislation affecting the practice of pharmacy, and FDA and DEA regulations of compounded drugs. |
| Repeals a requirement enacted into law as part of the PPACA of 2010 that requires consumers to obtain a prescription in order to utilize their FSA's and HSA's to purchase over-the-counter OTC medicines, "Restoring Access to Medication Act of 2015," H.R. 1270, S. 709. FDA's proposed changes to generic drug labeling. House Energy and Commerce 21st Century Cures Initiative. Senate Health, Education, Labor and Pensions 21st Century Cures Initiative. "Fairness to Pet Owners Act of 2015," S.1200. |
| Issues related to tamper resistant formulation of pharmaceutical drugs; Ensuring Safe Access to Prescription Medication Act of 2014 S. 2825 |
| PL 112-144 - The Food and Drug Administration Safety and Innovation Act, implementation H.R. 3204 - The Drug Quality and Security Act, implementation ***, 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 sequester, 21st Century Cures |
| Biosimilar naming - supporting Congressional action to seek FDA decision on naming and supporting FTC study of effect of naming on competition, Medicare Part D lock in and Medicare Part D issues concerning managed care pharmacy, supporting the reauthorization of the National All Schedules Prescription Electronic Reporting Act (S 480/HR 1725)and providing comments to CDC on opioid dispensing guidelines |
| Public Law 111-148, the Patient Protection and Affordable Care Act 0 Implementation issues related to FDA approval of follow on biologics and length of data exclusivity period, 340B drug pricing program, structure of the Medicare prescription drug benefit.; Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid reimbursement, fees assessed on the pharmaceutical industry, design and structure of the Medicare prescription; General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis.; Held discussions with Administration staff about 340B program requirements onparticipating pharmaceutical manufacturers., Held preliminary discussion with Administration staff on anti-viral drugs in the strategic national stockpile. |
| Food and Drug Administration Safety and Innovation Act Implementation Biosimilars Exclusivity Period Biosimilars FDA Guidance Implementation of Drug Quality and Security Act Implementation of the "Affordable Care Act of 2010" (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making |
| Issues related to 340B program. |
| Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation yet. |
| Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. No specific legislation yet. |
| Food and Drug Administration, Generic Drug User Fees |
| Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. S.1406-Saving Access to Compounded Medications for Special Needs Patients Act. |
| H.R. 793 - Ensuring Seniors Access to Local Pharmacies Act of 2015; H.R. 244 - MAC Transparency Act of 2015; Congressional Oversight of 340 B Program; Fairness to Pet Act Legislation |
| Tax issues related to orphan drugs. |
| Coverage for direct patient care services of qualified pharmacists under Medicare and other public health programs. |
| Legislation affecting the operation of compounding pharmacies and the availability of compounded medications. S.1406-Saving Access to Compounded Medications for Special Needs Patients Act. |
| Issues related to preventing prescription drug abuse. |
| Issues Related to Biosimilar Regulation, Labeling, E-Labeling and Access more reports at https://www.opensecrets.org/lobby/issue_spec.php?id=PHA&year=2015 |