Faced with an ever-expanding portfolio of oversight and regulatory responsibilities, coupled with depleted resources and a
decimated workforce, FDA is having a tough time meeting the high expectations of all its numerous constituencies.
To make matters worse, FDA must establish a host of new rules and policies to implement the FDA Amendments Act (FDAAA), intended
to boost FDA resources for drug review, at least until the agency is able to bring on board the hundreds of new staffers it
needs. At the same time, the Center for Drug Evaluation and Research (CDER) is under intense pressure to beef up post-approval
surveillance, which has only added to the strain on the agency.
The situation has become so serious that John Jenkins, director of CDER's Office of New Drugs (OND), is giving review division
chiefs "discretion" to reduce work on some review activities, even if that means missing some user-fee deadlines.
Jenkins explained that his office cannot keep up with a growing volume of requests to meet with sponsors, provide special
protocol assessments for innovative therapies, supply the reams of information demanded by Congressional committees, and still
meet every goal set by the Prescription Drug User Fee program (PDUFA 4). Jenkins thus advised OND office and division directors
to assess where it will be difficult to meet PDUFA review goals and to notify sponsors of anticipated delays.
Jenkins noted that there is "no specific end date" to the possibility of missing PDUFA deadlines because it may take years
to hire all the necessary personnel to remedy the situation. CDER has resources to add some 400 to 500 additional staffers,
but the task of hiring and training a whole new cadre of reviewers and analysts will consume considerable time and energy.
CDER is aggressively searching for qualified candidates, but must "navigate through the complex federal/HHS personnel system"
before making an official job offer, Jenkins explained. The delays, plus a pay structure that often "is not competitive to
what qualified candidates can make in the private sector," make it hard for FDA to attract and retain the best candidates.
While FDA has always had to play with PDUFA goal numbers, this explicit warning seems to go beyond the usual difficulties.
For biopharma companies, the development raises the prospect of added costs and delays in bringing new drugs to market, a
trend evident in FDA's declining drug approval rate. The agency approved only 19 innovative new drugs in 2007, 17 new molecular
entities (NMEs) plus two novel biotech therapies. That's way down from the peak of 53 new drugs in 1996, but in line with
a steady decline in new drug approvals since 2002. Another analysis indicates that FDA approved only 64 percent of all NDAs
in 2007; instead, it issued more non-approvable and approvable letters, which usually require additional data for final approval.
Sponsors say these trends reflect a more cautious environment at the agency in approving new drugs. CDER Director Janet Woodcock
maintains that FDA has not changed standards or become more risk-averse, but now has better tools for detecting and describing
safety problems, especially for drugs to treat chronic conditions. FDA officials acknowledge, though, that new treatments
in crowded drug classes will have to show clear advantage in efficacy or safety to gain market approval.
Capturing Adverse Events