12-15-2001

HEALTH: Still Headless at the FDA

It's not unusual for an Administration to take a year to nominate a
commissioner for the Food and Drug Administration. In the past, the delays
haven't seemed to adversely affect the agency's daily operations. But
these are not normal days. The FDA is front and center in the fight
against bioterrorism, and it needs a chief who can serve as an advocate
for funding and policy changes, say members of Congress and
observers.


"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.


Marilyn Werber Serafini

National Journal