Last week, we attended Politico Pro's panel discussion: "Deep DIVE - The Future of the FDA." It was a fascinating update from the panel that included Dr. Jeff Allen, the Executive Director of Friends of Cancer Research; Allan Coukell, Director of Medical Programs at The Pew Charitable Trust's Health Group; Sara Radcliffe, an Executive Vice President at Biotechnology Industry Organization (BIO); and Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research (CDER).
Of particular interest, the panel included a discussion of the FDA Safety and Innovation Act, the bipartisan bill signed by the President in July that reauthorized PDUFA for the fifth time. The guidelines established in PDUFA V begin on October 1, something we wrote about on Tuesday.
However, the user fee program established under PDUFA may be in jeopardy. The looming federal budget sequestration may decrease funding to the FDA to such a low level that the PDUFA V guidelines would no longer be valid, thereby slowing or halting new drug review. To date, most of the attention on sequestration has been on the forced cuts to military spending. Little or no attention has been directed to the drastic cuts facing the FDA and the impact that would have on access to new, safe and effective medicines. At the event, each panelist spoke dramatically and with great concern on this subject and all noted the FDA Safety and Innovation Act itself would be in jeopardy.
According to the guidelines in PDUFA V, the FDA has to spend a certain amount of federal appropriations before it can use any of the user fees paid by the industry. PDUFA V was specifically designed this way so new drug review was funded first by appropriations and supplemented by industry user fees.
We have spoken at great length about the importance of PDUFA to bringing new, safe and effective medicines to patients faster. With your help, we helped shape the conversation on the reauthorization of PDUFA this year and get it passed quickly by Congress. Sequestration impacting FDA's budget and slowing or halting new drug review under PDUFA could be devastating. There is still much to debate over sequestration, but it is one thing we will watch closely while urging Congress and President Obama not to disrupt the successful PDUFA program.