Jul 16 2012

New Provisions in the FDA Safety and Innovation Act (aka PDUFA V)

Next week, Ask Cato will be starting a weekly series to discuss the major changes in the FDA Safety and Innovation Act (FDASIA).  Here is a summary of the new law.

Seal of the U.S. CongressOn 09 July 2012, President Obama signed FDASIA (otherwise known as PDUFA V) into law.  The reauthorization of PDUFA V has been working its way through both houses of Congress since May and has received uncharacteristically broad bipartisan and bicameral support.  In 2007, PDUFA IV was hotly debated between the two chambers and was barely passed in time to replace the expiring PDUFA III, but this time, lawmakers were able to meet their goal of sending the President a reconciled bill well before the 30 September expiration date of PDUFA IV.

The new law will go into effect on 01 Oct 2012 and will sunset on 30 Sept 2017.

The FDASIA includes the following provisions:

  • A reauthorization of prescription drug user fees and medical device user fees (expected FDA revenue of $693 million and $595 million, respectively)
  • A new generic drug user fee (expected FDA revenue of $299 million), which includes fees for pending Abbreviated New Drug Applications (ANDAs), drug master files, new ANDAs and ANDA supplements, generic drug and active pharmaceutical ingredient facilities
  • A new biosimilar user fee, which includes fees for meetings with the FDA concerning the development of a biosimilar product, biosimilar IND submissions, biosimilar product applications and supplements, biosimilar establishment fees, and an annual fee for biosimilar products
  • Pre-IND meetings will no longer automatically be granted, and the FDA may provide a written response within 60 days of a pre-IND meeting request instead of granting a meeting
  • The renewal of the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act, and the Pediatric Medical Device Safety and Improvement Act.
  • The “Generating Antibiotic Incentives Now” (GAIN) Act, which provides an additional 5 years of market exclusivity, priority review, and fast track status for antibiotics to treat serious or life-threatening diseases
  • The development of strategies to improve patient participation at the FDA in medical product regulation
  • New requirements on reporting drug shortages, including biologics, and the development of a task force to generate a strategic plan to prevent future drug shortages.

Additionally, FDASIA introduces a midcycle meeting to discuss Risk Evaluation and Mitagation Strategies (REMS) for NDAs in review.

Items that that failed to be included in the final bill include a requirement for pharmacies to provide labeling for visually impaired and blind patients, a “track and trace” system to help prevent the distribution of counterfeit or adulterated drugs, and a reclassification of hydrocodone-containing drugs from a Class III to Class II status.

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