FDA Makes Changes to User Fee Program in Order to Comply with Congress’ “Safety First” Initiative:

What’s the Impact?

In 1992, the first prescription drug user fee program (PDUFA) was created. At the time, this was viewed by most as a risky endeavor since similar user fee programs for government services failed after a couple of years. The risk that the board took in supporting the user fee program has paid off. For the past 15 years, the FDA has provided reliable, predictable reviews for the pharmaceutical and biotechnology industry. However, the drug review system may be starting to unravel.

Janet Woodcock has been asked by FDA Commissioner Andrew von Eschenbach to reassume her position as head of CDER and eliminate the problems facing the FDA’s user fee program. She established PDUFA and effectively managed the user fee program until 2003 when she accepted new assignments under the FDA’s Critical Path Initiative. Her track-record and reputation makes her an excellent candidate for the job.

The user fee program is in flux, and the FDA is under pressure to implement new drug safety initiatives. Patient safety is paramount to the FDA and Congress is pressing hard, putting more emphasis on patient safety. The FDA’s responsibility to its sponsors under PDUFA has permitted occasional missed deadlines in the review process. But for the first time, the FDA is issuing a center-wide directive that allows review times to slide.
The FDA’s struggle to meet congress’ safety initiative under PDUFA will impact and change the review process dramatically.

Review timelines may be extended by two months: Instead of 6-month priority reviews and 10-month standard reviews, the FDA division directors have the command to initiate reviews lasting 8 or 12 months. Sponsors should plan for an extension. Applications that need an advisory committee will likely need more time with the agency. The FDA is under pressure to engage advisory committees for all NME’s, and therefore extensions will be the rule rather than the exception.

Meeting requests will be denied more frequently: Managers reserve the right to turn down any meeting request throughout the NDA filing process. Congress’ safety initiative provides the FDA with a larger workload and meeting requests may be denied.

For 2008, it seems as if we can expect longer review times, limited FDA advice and counsel, and more advisory committee meetings.

Questions Pending: 

Is this the beginning to the end of the user fee program? 
Can Janet Woodcock get the FDA’s user fee program back on track?
How much impact will the FDA’s current crisis have on our future? 

Final Thought: While Janet Woodcock’s return to CDER is an encouraging sign for the pharmaceutical and biotech industry, the challenges are still significant.