IRA — Rare Access Action Project

RAAP APPLAUDS BIPARTISAN LEGISLATION TO FIX “PILL PENALTY”

Washington, D.C. (2-5-24) – The recently enacted Inflation Reduction Act (IRA), creates different Medicare price negotiation timelines for large and small molecule therapeutics. This difference is now referred to as a “pill penalty” because of the shorter timeframe to negotiate that most small molecule pills will now have as compared to biologics (i.e. larger molecule drugs).

BIDEN ADMINISTRATION “MARCH-IN” POLICY THROWING GAS ON THE IRA FIRE THAT'S BURNING RARE DISEASE PATIENTS HOPE

Washington, D.C. (12-12-2023) - On December 7th, the Biden administration announced its plans to clarify the Bayh-DT Hopeole Act, formally known as the Patent and Trademark Act Amendments, and use the “march-in” clause to re-license high priced drugs that had been a part of a public-private agreement. With this announcement the Biden administration will provide guidelines to federal agencies on how to use “march-in” authority when medications are deemed unavailable to the public on “reasonable terms.”

Inflation Reduction Act to Harm Rare Disease Innovation RAAP Supports Legal Efforts Targeting Price Setting Provisions

Washington, D.C. (7-11-23) - The recently passed Inflation Reduction Act (IRA) was hailed by supporters as a major milestone for reducing costs across a range of sectors, including prescription drug prices. The Rare Access Action Project (RAAP) was involved in the debate from the beginning warning that certain provisions could have detrimental effects on innovation, particularly in the orphan drug space.