Bill Looks to Make Changes to FDA's Accelerated Approval Pathway

| 05 April 2012

A new piece of legislation released in discussion draft form by the Senate Health, Education, Labor and Pensions Committee aims to "overhaul" the US Food and Drug Administration's (FDA) Accelerated Approval pathways, reports The Hill.

Among other things, the bill would "create a new 'breakthrough' designation to provide more flexibility and certainty for developers of new medicines intended to address serious or life-threatening diseases or conditions," reports The Hill.

The draft legislation, released 4 April 2012, also includes the Advancing Breakthrough Therapies for Patients Act (ABTPA) bill released 27 March by Sens. Michael Bennet (D-CO), Richard Burr (R-NC) and Orrin Hatch (R-UT).

That legislation would "expedite FDA approval and provide more flexibility when a drug or treatment shows dramatic responses early in development, while still ensuring drug safety and efficacy," said the Senators in a statement.

The draft legislation is slated to be tacked on to the reauthorization of the Prescription Drug User Fee Act (PDUFA) legislation that must be approved before 30 September if the agency is to maintain its current level of funding.

The Hill - Senate Health panel floats proposal for speedy FDA approval of life-saving drugs

Discussion draft: To amend the Federal Food, Drug, and Cosmetic Act with respect to certain reauthorizations

Regulatory Focus - Senators Draft Bill to Expedite Drug Approval

See all Regulatory Focus news stories about PDUFA.