"It's a problem," said Sen. Bill Frist, R-Tenn., who is a member of the Senate Health, Education, Labor, and Pensions Committee's Public Health Subcommittee. Frist is the author of bipartisan legislation, now pending in the Senate, that would authorize spending $3.2 billion to combat bioterrorism. "The FDA is critically important so that we can target [bioterrorism] agents or figure out how to treat smallpox," he said. "If there's no leadership at the top, it's hard for scientists to know what to do." (The Bush Administration also hasn't nominated a director for the National Institutes of Health, but Frist predicted that the FDA selection would come first.) Up until 1988, the Senate did not confirm FDA commissioners, a situation that had made it easier to fill the post.
Among FDA-watchers, the absence of a commissioner raises several troubling questions: Who's evaluating the speed of drug approvals? Who's deciding how to expedite reviews of drugs and vaccines to counter bioterrorism threats? Who's answering questions about RU-486, the abortion pill? Who's deciding the FDA's role in, and position on, controversial cloning issues?
So far, the White House's efforts to fill the position have been unsuccessful. President Bush was prepared to nominate Michael Astrue, a biopharmaceutical company executive, when a powerful group of Senate Democrats objected. In a July 13 letter, Senate Health Committee Chairman Edward Kennedy, D-Mass., and six other Senate Democrats urged Bush not to nominate anyone with links to the pharmaceutical industry. Astrue is senior vice president of administration and general counsel for Transkaryotic Therapies Inc. in Cambridge, Mass. He was a presidential legal adviser in the first Bush Administration and was later general counsel at the Health and Human Services Department.
"It would be unprecedented for the commissioner to be appointed from an industry regulated by the FDA," the letter stated. "To do so could raise irresolvable conflicts of interest, undercut public confidence, and undermine the agency's worldwide reputation as the gold standard of public health regulators." With Kennedy in charge of the confirming committee, and with the Senate so closely divided, the Administration yielded. Astrue withdrew his name from the running at the end of October.
Since then, FDA observers say, it's unclear how aggressively the Administration is pursuing the nomination of its current front-runner, Lester Crawford, a veterinarian and the head of a food-safety research group. Crawford is the choice of Health and Human Services Secretary Tommy G. Thompson, but industry observers say that the White House continues to interview other candidates. Crawford has a doctorate in pharmacology and is executive director of the Center for Food and Nutrition Policy at Virginia Polytechnic Institute and State University.
The FDA is important in the fight against bioterrorism because it's the agency that approves new drugs and vaccines. Fears of bioterrorism are spurring the debate about how to speed up the drug-approval process in emergency situations without compromising safety. (HHS, FDA's parent department, recently signed a contract with a private company to expedite the production of more than 200 million doses of a new smallpox vaccine.) The FDA is also responsible for food safety; some experts worry that food could become a terrorist target.
Congress must reauthorize the FDA modernization act next year, and big questions have arisen about how the agency's expedited review process for new drugs is working. Initially, the FDA sped up drug reviews for AIDS treatments, then for other potentially lifesaving remedies, to get the drugs to market faster. But questions remain about which drugs should qualify for quicker reviews and whether safety is at stake. "We've seen an exploitation of [the quicker process], where you have high blood pressure and diabetes drugs going through the process," said Mary Beth Buchholz, vice president of the Sheridan Group, a lobbying firm that works with consumers.
Moreover, there are serious new policy questions about the FDA's role in protecting the food supply--particularly imported food. Bush's emergency relief budget included a request for $61 million to allow the FDA to hire 410 new food inspectors, lab specialists, and other experts, and to invest in new technology and equipment to monitor food imports. In his bill, Frist is requesting $524.5 million to give additional tools to the FDA to ensure that proper records are maintained by those who manufacture, process, pack, transport, distribute, receive, hold, or import food.
Right now, Thompson is making the most-critical decisions for the FDA. But for the most part, the FDA's second leadership tier is running the agency, and observers say it's just not as good as having a political appointee who can represent the administration in high-level interagency meetings. The FDA is "operating on autopilot," said one industry analyst. "In terms of policy leadership, there has been no one there for some time who is able to execute policy leadership." Still, FDA observers say a nomination can't be expected anytime soon.