Drug Safety Is Top Issue for New FDA Commissioner Crawford

In moving quickly to name a permanent commissioner for the US Food and Drug Administration (Rockville, MD, www.fda.gov), the Bush administration took a relatively easy path to filling the job by naming long-time acting commissioner Lester Crawford to the post. The nomination was viewed as a just reward for Crawford's four years of service as acting and deputy FDA commissioner. Crawford ran FDA for more than half of Bush's first term, a period filled with controversies over drug safety, importing, pricing, and vaccine shortages.

Pharmaceutical manufacturers expressed support for the nomination, pleased primarily at the prospect of filling the void created by years of unconfirmed FDA leadership. Crawford has been supportive of new drug development initiatives and efficient application approval processes, and is not likely to shake up the agency. He also has no ties to drug companies, a main requirement for Senate Democrats. A veterinarian with a doctorate in pharmacology, Crawford lacks the MD credential held by most of his predecessors and is regarded as having more expertise in food safety and animal medicine than in drugs and medical products for humans.

Although praised in general, Crawford's appointment raised protests. Public-interest consumer groups complained that he has been slow to respond to escalating concerns about safety issues related to painkillers, antidepressants, and dietary supplements. FDA's delay in approving the "Plan B" morning-after pill, allegedly because of political pressure from the Bush administration, remains a bone of contention. Senate Republicans promised speedy confirmation hearings, which may be more interesting than usual; Crawford can't claim that he's new to Washington and thus unable to answer what are sure to be a host of tough questions about drug importing and safety.

The administration moved to defuse such criticisms by announcing new programs to enhance FDA's regulation of drug safety and create a "new culture of openness and enhanced independence" at the agency. In announcing Crawford's nomination to FDA employees, HHS secretary Mike Leavitt unveiled new policies designed to enhance public disclosure of drug safety concerns, including the formation of a new Drug Safety Oversight Board (see this week's ePT story, "FDA Creates New Drug Safety Board.")

Ironically, these announcements came the day before the much-anticipated meeting of two FDA advisory committees to discuss safety issues related to Cox-2 inhibitors and anti-inflammatory drugs. The agency's advisory committees on arthritis and drug safety and risk management discussed the benefits of these painkillers compared to the risks of cardiovascular and gastrointestinal adverse events. The key issue is whether safety problems are so prevalent in all Cox-2 inhibitors to warrant removing them all from the market. The related question is whether these drugs offer sufficient benefits to certain patients to override risk factors. If the committees recommend keeping Cox-2 inhibitors are to remain on the market, FDA will seek advice about what kind of information is needed for approval of new drugs in this class and what requirements and curbs should be put in place regarding marketing and risk communication.