Proposed Federal Legislation

Legislation Proposed in the 114th Congress Impacting FDA and the Medical Products Industry


  • H.R.244 – Pharmacy Benefits Manager StandardsA bill to set standards for pharmacy benefit managers to further transparency of payment methodologies. Introduced by Rep. Doug Collins. a/k/a The MAC Transparency Act.
  • H.R.271 – Creating Options for Veterans Expedited Recovery Act would establish a commission to examine the evidence-based therapy treatment model used by the Secretary of Veterans Affairs for treating mental illnesses of veterans the potential benefits of incorporating complementary alternative treatments in non-DOVA medical facilities.
  • H.R.406Combination Drug Development Incentive Act – Introduced by Rep. Jason Chaffetz with no co-sponsors as of 2/11/15 – would provide incentives for the development of combination drugs. No companion bill as of 2/11/15.
  • H.R.471 – Prescription Drug Diversionto improve enforcement efforts related to diversion and abuse. As of 1/28/15, no title, no summary available.
  • H.R.790 – Compassionate Freedom of Choice Act of 2015 – would allow the manufacture, importation, distribution and sale of investigational drugs and devices intended for use by the terminally ill who execute informed consent introduced by Rep. H. Morgan Griffith with one co-sponsor as of 2/25/15 and no companion bill in the Senate.
  • H.R.1600Patients’ Access to Treatments Act of 2015 – Would establish cost-sharing limits on plans that cover prescription drugs and would prohibit them from imposing higher cost-sharing requirements on specialty drugs than for other prescription drugs in a non-preferred brand drug. Introduced by Rep. David B. McKinley the bill has 50 bipartisan co-sponsors, no companion bill.


  • S 31 – Medicare Prescription Drug Price Negotiation Act Introduced by Senator Amy Klobuchar would allow HHS to negotiate prices for drugs under Medicare Part D.
  • S.122 – Safe and Affordable Drugs From Canada Act – Introduced by Senators McCain and Klobuchar would allow Americans to order prescription drugs from approved pharmacies in Canada.
  • S.131 – Fair Generics ActIntroduced by Senator Vitter and co-sponsored by Senator Franken, a retread from the last Congress, the bill would amend Hatch-Waxman to address practices whereby it is perceived that manufacturers seek to delay the entry of generics to the market.
  • S.185 – PATH Act – Introduced by Senator Orrin Hatch would create a limited population pathway for the approval of certain antibacterial drugs meaning that approval of the drug could be made for a select population where there is an unmet need or life-threatening condition.  Also known as the “Promise for Antibiotics and Therapeutics Act”.
  • S.481 – No TitleWould change the way drug scheduling is recommended by HHS. The bill has one co-sponsor, no companion bill as of 2/25/15.
  • S.483 – Bill to Improve Enforcement Efforts Related to Prescription Drug Abuse and Related Purposes – Introduced by Senator Orrin Hatch, 1 co-sponsor, no companion bill as of 2/25/15.
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