Every so often, EyeonFDA has an update for you on legislation that is proposed in the Congress that would impact the medical product marketplace if passed. The new Congress has just two months old and while the last Congress was not among the most productive, there has been some legislation that was proposed in the 113th that has resurfaced in the 114th.
Some of the more notable highlights include proposals to expand assets – to allow for the importation of drugs from Canada and one to open up pathways to investigational drugs.
- H.R.244 – Pharmacy Benefits Manager Standards – A 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.406 – Combination Drug Development Incentive Act – Introduced by Congressman 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 Diversion – to 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 Congressman H. Morgan Griffith with one co-sponsor as of 2/25/15 and no companion bill in the Senate.
- 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 Act – Introduced 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 Title – Would 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.
The legislative overview will be periodically updated on the “Proposed Legislation – 114th Congress” tab on the EyeonFDA blog site.