Legislation Proposed in the 113th Congress Impacting FDA and the Medical Products Industry
House
- H.R. 413-To eliminate the 2-year delay in including oral-only ESRD-related drugs in the Medicare ESRD prospective payment system, as provided under section 632(b)(1) of the American Taxpayer Relief Act of 2012.
- Link to Sponsor Peter Welch Release on the Bill. - H.R. 460 - Patients’ Access to Treatments Act of 2013 - Establishes cost-sharing limits for health plans that cover prescription drugs and use a formulary or other tiered cost-sharing structure.
- H.R. 486 – Stop Tampering of Prescriptio Pills Act of 2013 – Requires FDA to prescribe new drug application requirements for abuse-deterrent drugs that (1) contain an opiate, (2) are oral, (3) have properties that lend themselves to abuse/misuse, and (4) contain one or more additional ingredients intended to deter abuse through pharmacological effects.
- H.R. 672 – Prescription Drug Abuse Prevention and Treatment Act of 2013 - Provides for award grants to states and non-profits for consumer education about opiod abuse, including methadone abuse and puts into place new training requirements for practitioners.
- H.R. 923 – Say No to Drug Ads Act - This would eliminate any tax deduction for the cost of direct-to-consumer advertisting for prescription drugs.
- H.R. 928 -Medicare Prescription Drug Savings and Choice Act of 2013 - Aims to lower prescription drug prices through directing HHS to negotiate prices with industry, to establish a formulary and to encourage the use of a formulary and formulary practices.
- H.R. 1012 – Safety and Fraud Enforcement for Seafood Act - Establishes enhanced fraud detection and reporting and sets up public web site to list exporters of seafood to the U.S. and track violations. Companion bill is S.520.
- H.R. 1024 – Medication Therapy Management Empowerment Act of 2013 -Amends Part D to provide access to services under medication therapy management programs for Part D eligible individuals with a single chronic disease.
- H.R. 1366 - Stop Oxy Abuse Act of 2013 - Directs FDA to modify the approval of any drug containing controlled-release oxycodone to use for the relief of severe-only pain instead of moderate-to-severe pain. As of this writing (6/11/13) there is no companion bill in the Senate and there are eight co-sponsors.
- H.R. 2031 - TEST Act – Trial and Experimental Studies Transparency Act – Expands the clinical trials that must be reported to the clinical trial registry data bank to include (1) any interventional study of a drug conductd outside the U.S. which is used to support U.S. approval and postmarket surveillance that involves data collection from humans. As of this writing (6/11/13) there is no companion bill in the Senate.
- H.R.2186 – Verifying Authority and Legality in Drug (VALID) Compounding Act – Would have states regulate “traditional” and small compounding pharmacy activities while seeking to ensure that compounding that operates more along the lines of drug manufacturing are regulated by FDA as drug manufacturers. As of this writing (6/11/13) there are three co-sponsors and no companion legislation in the Senate.
Senate
- S.77 – Prescription Drug and Health Improvement Act of 2013 – Repeals prohibition against interference by HHS Secretary with negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors, and requires a particular formulary or instituting price structure for the reimbursement of covered part D drugs.
- S.117 – Medicare Prescription Drug Price Negotiation Act of 2013 – This bill would direct the HHS Secretary to negotiate prices for drugs under the Medicare Part D Prescription Drug Program. Related bill in the House is H.R.1102.
- S.214 – Preserve Access to Affordable Generics Act - Would permit the FTC to initiate a proceeding against parties to any agreement that resolves or settles a patent infringement claim in connection with the sale of a drug.
- S.348 – Prescription Drug Abuse Prevention Act of 2013 - Puts into place training requirements for prescribers of methadone or other opioids and to require each registered opioid treatment clinic to make arrangements for each patient who is restricted from having a take-home dose to receive a dose under supervision when the clinic is closed. (Related to H.R.672)
- S.408 – Medicare Prescription Drug Savings and Choice Act – Related to H.R.928.
- S.504 - FAIR Generics Act – Also known as the Fair and Immediate Release of Generics Act – Would make applicants for a generic drug eligible for exclusivity only if they have not entered into a disqualifying agreement with a brand name drug patent holder.
- S.520 – Safety and Fraud Enforcement for Seafood Act – Establishes enhanced fraud detection and reporting and sets up public web site to list exporters of seafood to the U.S. and track violations. Companion bill is H.R.1012.
- S.959 – Pharmaceutical Compounding Quality and Accountability Act – Like the House bill (not related), traditional compounding would be regulated at the state level while non-traditional compounding manufacturers would be regulated by FDA and would set up a fee system to address the costs.
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