But by late July, most members of the Senate, including Grassley, agreed that FDA is better off with a permanent chief than without. And with five years as acting or deputy commissioner, Crawford seemed to deserve the job. But he failed to win unanimous approval from the Senate, a sign of a tough road ahead as Congress and consumers continue to scrutinize FDA activities and initiatives.
Vaccines to Vioxx
At that hearing, Rep. Rosa DeLauro (D-CT) pressed Crawford to support legislative changes in FDA operations, citing flu vaccine shortages due to "inept oversight," delayed withdrawals of drugs such as Vioxx, and failure to enforce an animal-feed ban to protect against mad cow disease. In his written testimony, Crawford outlined FDA's key administrative challenges for the coming year. He noted difficulties implementing a new user-fee program for medical devices and spurring development of new vaccines and countermeasures to protect against bioterrorism. And the agency is beginning a massive move to a new White Oak campus in the Maryland suburbs, a costly and disruptive process.
Probably the most important item on Crawford's agenda is to show that FDA can identify, prevent, and manage drug safety problems. Members of Congress have proposed legislation authorizing FDA to require drug label changes that reflect safety concerns and to force companies to complete promised Phase IV studies. Some legislators also want to expand the Office of Drug Safety (ODS) and make it more independent of drug-approval activities in the Center for Drug Evaluation and Research (CDER).
FDA officials look to a panel convened by the Institute of Medicine (IOM) to provide a roadmap for revising how it monitors adverse events. At the panel's July meeting, CDER officials described FDA's system for capturing and assessing information on drug risks and benefits, emphasizing the importance of interaction between ODS and the Office of New Drugs (OND). Paul Seligman, who oversees ODS as director of CDER's Office of Pharmacoepidemiology and Statistical Science (OPPS), acknowledged that additional resources could help FDA gain more information on drug utilization and safety.