Unclogging the backlog of generic drugs seeking approval

Last week, the FDA’s deputy commissioner for medical and scientific affairs, Scott Gottlieb announced that the FDA would begin a new program to unclog the generic drug approval backlog. I hope it unclogs soon enough. According to IMS Health and SG Cowen estimates, “there are 72 major drugs, each with 2004 US sales of $100M or greater, that will lose patent or exclusivity protection through 2009. These drugs represent combined 2004 US sales of approximately $61B, which amounts to 27% of the total US retail pharmaceutical market.”

The part of the program which received the greatest attention last week was the user fee program. The user fee program which is modelled after the Prescription Drug User Fee Act (PDUFA) which hit the branded pharma world in 1992.

In the recent Washington Post article FDA to Explain Need to Charge Fees for New Generic Drugs, you can read about the complaints from the generics industry association president, Kathleen D. Jaeger:

“Our problem with user fees is that they currently would not guarantee that generic drugs would be reviewed and approved any faster. There are many other legal and regulatory obstacles — ways for the branded industry to keep our competition off the market — and they would have to be addressed before the industry could feel comfortable with any user-fee program.”

This is a valid concern, and according to the Washington Post, “there will be a number of agency initiatives to speed generic reviews. One is a formal lifting of a ban on direct telephone conversations between FDA reviewers and generic drug makers. Another involves grouping bioequivalence review applications for the same or similar drugs.”

I was interested in learning how PDUFA was received by the branded pharma manufacturers. According to the Pharmaceutical Research and Manufacturers Association (PhRMA), they cite:

PDUFA is a shining example of public policy that has produced positive and tangible results. PDUFA has provided FDA with needed revenue to hire additional reviewers and upgrade information technology, thus enabling the agency to conduct more timely reviews for human drug and biological products without compromising review quality and consumer safety. PDUFA has provided FDA with over 1,000 new drug reviewers and reduced drug review times from 30 months to less than 18 months. PDUFA has largely eliminated the drug lag that existed between the U.S. and the rest of the world. Today, roughly half of all new drugs are approved first in the U.S., and less than 30 percent are marketed in Europe for over a year prior to U.S. approval.”

The results of PDUFA are clearly impressive and tangible. I understand that there are other issues that need to be addressed for speedier generic drug approval, but I hope that this will move things in the right direction.

February 22, 2006

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