FDA legislative action, now with commentary from the New England Journal of Medicine

By Susan Wood

Next week both the Senate and House are moving forward on legislation to reauthorize the Prescription Drug User Fee Act (PDUFA), along with other key FDA legislation.  The Senate will be âmarking upâ a large omnibus piece of legislation that combines PDUFA with drug safety legislation, pediatric legislation, and medical device legislation.  The version of the bill that has been released is nearly 300 pages long, and so far only takes small steps toward strengthening the Kennedy-Enzi drug safety bill introduced earlier this year.

If you want to learn some of the basics linking user fees, the FDA budget and drug safety, we have just issued a white paper âReauthorizing the Prescription Drug User Fee Act: How are PDUFA, the FDA budget, and Drug Safety Related?â This is not a position paper, but rather a brief overview of the history, legislation, connections and varying positions that are in play now as these legislative actions take place.

The first part of the current bill in the Senate is reauthorizing PDUFA for the next five years. As was written in our open letter to Congress last month, âUser fees may appear to save the taxpayer money, but at an unacceptable cost to public health.â

One of the signers of this letter, Dr. Jerry Avorn, has an article today in the New England Journal of Medicine, entitled âPaying for Drug Approvals â Whoâs Using Whom?â  Todayâs early release of three articles on FDA reform demonstrate the depth and breadth of need for change at the FDA.  Former Commissioner Dr. Mark McClellan also has an article, as do Drs. Sean Hennesey and Brian Strom.

Dr. Avorn compares the problems created by having a user fee system with those created when the pharmaceutical industry expanded its funding of physician education â through free food, gifts and sponsored speakers â and concludes that âthere is no free lunchâ.  He notes the increasing proportion of the FDA drug review costs being paid for by industry fees.  He ties that to the inadequate amount of funding that will come for the improvement of the drug safety system.

In all three of the papers, authors of different perspectives highlight the lack of funding for FDA to carry out its mission.  Like the four former FDA Commissioners who spoke at the SKAPP FDA Policy workshop in February, they wish that federal taxpayer dollars were adequate to cover the real costs of the protection of public health that FDA provides.  Only Dr. Avorn calls for real change in PDUFA â the others accept it as reality and merely ask for more funds.

Dr Avorn along with Drs. Hennesey and Strom do join together in noting a particularly striking fact.  The PDUFA funds that will be allowed to be targeted for post-market surveillance and safety concerns is only less than 6% of the total funds raised through PDUFA.  That tells us unfortunately that the priority is not safety in this legislation.

Several Senators are working to strengthen the PDUFA and drug safety legislation as it moves next week in the Senate Committee on Health, Education, Labor and Pensions.  It surely needs that!  A package of provisions â being called the SOS strengthening package (for Science, Openness, and Safety) is being discussed behind the scenes so that the bill will address some of the underlying weaknesses.

These provisions are really needed, yet donât address the underlying problem with PDUFA or the real need for increased direct funding from Congress.

The House will start taking this up next week â perhaps they will listen to Dr. Avorn and others about the need for real reform.  The House starts out with a stronger drug safety bill and some Representatives have been asking questions about the need to ârebalanceâ PDUFA with appropriations.

This train is moving really fast â and it will have long term effects on all of FDA.  We need to work even harder for that elusive strong and effective FDA. 

Susan Wood is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).