Jill Wechsler
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The Food and Drug Administration is struggling to implement a host of new drug safety policies and programs and still meet
review goals set by the Prescription Drug User Fee program (PDUFA). Janet Woodcock, director of the Center for Drug Evaluation
and Research (CDER), acknowledges a slowdown in drug approvals.
The FDA Amendments Act (FDAAA) of 2007 added new requirements for assessing postmarket studies and determining the need for
Risk Evaluation and Mitigation Strategies (REMS) at the time of approval, she explains, but with no extension in review times.
CDER has hired more staff and is implementing new procedures to make the review process more efficient. Electronic submission
and review systems for drug applications would help, but these innovations remain far from reality, and fewer applications
are approved in the first review cycle.
In fact, the United States may be falling behind Europe in approving innovative therapies for patients. At a meeting in September
sponsored by the Institute of Medicine (IOM) to evaluate safety initiatives established by FDAAA, Merck Executive Vice President
Peter Honig noted that first-cycle approval trends are down and that user fee approval dates are "routinely missed" due to
increased scrutiny of safety issues.
FDA is "clearly struggling" with postmarket safety demands, he said, suggesting that "drug lag" may be rearing up once more
as European regulators approve some new drugs for market faster than FDA. The approval slow-down is having a noticeable impact on drugs granted priority review status by the agency, a designation
traditionally reserved for the most innovative and important new therapies. In the past, about 70% of priority review applications
gained first-cycle approval, but this proportion dropped to 50% in 2008, according to a recent report from Parexel Consulting.
User fee approval targets are 10 months for new drug applications (NDAs) and six months for a priority application, and it's
particularly difficult for FDA staffers to tighten up that six-month review process.
The good news is that manufacturers are submitting more NDAs to FDA and that the approval numbers are going up. Parexel cites
147 NDAs pending at FDA at the beginning of this year (2009), a notable increase from the 86 under review a year earlier.
The number of applications for new molecular entities (NMEs) is holding steady, but the percentage enjoying first-cycle reviews
is down.
