Without clear leadership, the FDA is falling short

WASHINGTON —The Food and Drug Administration has been without a permanent leader for more than two-thirds of President Bush's tenure in office, and major unresolved problems are piling up at the federal agency in a time of huge medical and scientific change.

With the FDA stuck in the bureaucratic equivalent of slow gear, critics as well as supporters — in a rare point of agreement — say the agency is in danger of losing its standing in setting regulatory policy in the rapidly evolving medical and scientific fields.

At the heart of the continuing stalemate over Senate confirmation of a permanent FDA commissioner is the unresolved question of what role religion and ideology should play in making science policy.

Many experts think the slide at the FDA could continue for the rest of Bush's term.

The last permanent commissioner, Lester Crawford, was confirmed in 2005 then quit unexpectedly after two months. The current nominee, acting Commissioner Andrew von Eschenbach, a recognized cancer specialist with ties to the Bush family, may never get a vote in the Senate.

The circumstances under which Crawford left remain murky. He never explained his abrupt departure to his closest staff at the agency. He is under investigation by the Health and Human Services inspector general into possible undisclosed financial conflict of interest, a federal official said Friday.

A full plate

Meanwhile, among problems awaiting decisive action at the agency: Fixing the drug-safety system, which too often fails to catch deadly side effects of medications already on the market and reversing the worrisome decline in new drugs being submitted for approval.

The immediate issue is a standoff between the Bush administration and Senate Democrats over how to regulate sales of the "morning-after" birth-control pill known as Plan B.

"At this point, the political process has overwhelmed any middle ground," said Dr. Eve Slater, a former assistant secretary for health in Bush's first term. "Let's do away with the cumbersome political process that paralyzes the ability of the FDA to do its job."

Slater said she was "disgusted with both sides" in the standoff. "Science is just being put into the meat grinder and is being politicized," she said.

The lack of a permanent FDA commissioner has aggravated the strains between the administration and much of the scientific community, coming on top of disagreements over such issues as global warming, stem-cell research and the teaching of evolution.

"There is a problem with this administration in its lack of attention to science, and its lack of willingness to follow science," said Dr. Brian Strom, chairman of biostatistics and epidemiology at the University of Pennsylvania medical school. "It's an administration that doesn't seem to want to hear scientific results it doesn't like."

A morale problem

Within the FDA, morale and effectiveness have also taken a hit.

"It's generally more difficult to do everything," said a senior official, who asked not to be identified because the interview was unauthorized. "People don't know whether [acting commissioner von Eschenbach] is the person who is going to have to be reckoned with for the next few years, or whether he's going to disappear."

"It definitely hurts morale," the official added. "People feel like the agency is not a priority for the administration."

The FDA's stalling of a decision on whether to allow over-the-counter sales of the "morning after" contraceptive has galvanized critics on the left and alienated some Republicans, who had hoped the agency would find a middle ground and make the drug more easily available for adult women.

Ignoring its own medical reviewers' recommendations for approval, the agency has adopted delaying tactics recently characterized by a federal judge as having "all the earmarks of an administrative agency filibuster."

The judge is hearing a lawsuit filed by the Center for Reproductive Rights that seeks to compel approval.

"I think the FDA ought to figure out a way to let Plan B be sold over the counter," said economist John Calfee of the business-oriented American Enterprise Institute think tank and a supporter of the agency. "It has become a political issue that is seriously interfering with progress at the FDA."

Some religious conservatives in the administration's political base are concerned that Plan B is tantamount to an abortion drug. Making it widely available without a prescription will encourage promiscuity, they argue. Without a decision on Plan B, influential senators will not permit a vote on the FDA commissioner.

"We agree that the FDA needs a permanent commissioner," said Sen. Hillary Clinton, D-N.Y., one of the senators blocking a floor vote on von Eschenbach. "However, I think there is a larger issue here, which is the standard by which the FDA is making decisions. If they are beholden to an ideological position, I don't think it matters whether they have an acting or a permanent commissioner."

Fixed term suggested

Ironically, Senate confirmation of the FDA commissioner was originally seen as a reform that would insulate the agency from political pressure. The first commissioner to win Senate approval was Dr. David Kessler in 1990. He won plaudits for taking on the tobacco industry while serving for more than six years, first under President George H.W. Bush and then President Clinton.

During the current administration, two nominees have won confirmation but have resigned, leaving the agency with only an acting head for a total of 45 months out of the 63 months George W. Bush has been in the White House.

Now some are calling for the commissioner to be appointed for a fixed term of five years, as are the heads of other technical agencies such as the Federal Aviation Administration and the Nuclear Regulatory Commission.

"Congress and the White House have made this position too political," said Dr. Raymond Woosley, head of an independent institute that seeks to speed the development of safe new drugs.

"They need leaders chosen for their scientific and medical expertise, and then they need to get the heck out of the way and let them do their jobs," added Woosley, who works with the FDA and industry.

Still on the job

To be sure, the lack of a permanent commissioner has not prevented the FDA's 10,000 employees, who are responsible for overseeing roughly one-fourth of all consumer products, from conducting day-to-day business. Proposed new drugs get reviewed, advisory meetings are held, safety problems get investigated.

But what is missing is the strong, continuing leadership that is necessary of complex and contentious problems are to be addressed expeditiously.

"It's like saying that once the trucks are rolling, you don't need generals to run a war, you just need sergeants," said Dr. Alastair J.J. Wood of Vanderbilt University, an adviser to the FDA on safety issues. "Well, wars are seldom won with just sergeants."

Two critical issues before the FDA are watching for safety problems with drugs that have been approved and developing a faster system for translating scientific progress into new and better medications.

The two issues are intertwined in complex ways. Without a stronger safety system, the agency may not be able to convince Congress and the public that it is wise public policy to cut the time new drugs spend in testing and development.

More than a year and a half after the blockbuster painkiller Vioxx was withdrawn because of heart risks, congressional investigators found the FDA still lacked a reliable system for spotting emerging safety problems. Because drugs are tested only on a few hundred, or a few thousand, people during development, relatively rare side effects may not turn up until tens or hundreds of thousands have taken a medication.

Meanwhile, new drug approvals have fallen from the pace set in the 1990s. The 20 issued last year represent the second-lowest level in more than a decade. Much of the problem, said Woosley, is the that the number of new products submitted by industry to the FDA is dropping, even as funding for medical research keeps rising.

"The system is absolutely broken," he said. "Why put more money into science with that kind of losing return on investment?"

The FDA has been working on a strategy to try to deal with the problem. Called the Critical Path Initiative, it would use new technologies and lessons learned from the successful development of AIDS drugs to accelerate drug approval, ostensibly without sacrificing safety.

For example, one of the projects in the initiative calls for drug companies to share information on lab tests that can predict the safety of new compounds. That could eliminate duplicative, time-consuming tests and experimentation. The safety project is being carried out under the auspices of Woosley's Critical Path Institute in Tucson, Ariz.

No advocate on board

While the FDA strategy has support from industry and academic researchers, it has not sparked widespread interest in Congress or among the public. Part of the reason is that the FDA lacks a high-profile advocate.

Even some Democrats say von Eschenbach could fill that role if he could win confirmation.

"I believe he would be a very good director of the FDA," said Rep. Rosa DeLauro, D-Conn., who developed a working relationship with him during his service as director of the National Cancer Institute. "He is a very bright individual, at the top of the medical profession."

Nonetheless, six weeks after Bush nominated him, no confirmation hearing has been scheduled for von Eschenbach. "Plan B is the 800-pound gorilla in the room," DeLauro said. "He has got to come to grips with that issue, and if he doesn't, he may not get confirmed."