Plan B on the Hill

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The confirmation of the current acting commissioner and former National Cancer Institute director Andrew von Eschenbach to be Food and Drug Administration commissioner is on hold because Sen. Hillary Clinton and other senators are blocking the nomination. The reason? Mrs. Clinton wants the FDA to decide whether it will approve making the emergency contraceptive product known as Plan B available for retail purchase.

Mrs. Clinton claims that the FDA's failure to make a decision is based on political pressure from people opposed to abortion in most circumstances. "What we are witnessing, she said, " is the FDA... being run not on the basis of science, but on ideology." She should know. The Clinton administration pressured the FDA to delay marketing of a home HIV test, not because it was unsafe, but because of the alleged emotional reaction people might have about finding they were HIV-positive. Some AIDS groups, including those that did clinic testing and regarded the home test as competition, raised this concern.

Also during the Clinton administration, the FDA held a hearing on silicon breast implants, deeming them safe. The media and Congress went wild and found dozens of women who claimed they had been mutilated by implants. FDA Commissioner David Kessler reshuffled the panel that decided to support a ban.

The FDA, for better or worse, has held up other products deemed safe because of what can be called political or policy concerns. Usually the FDA responds in one of two ways:It becomes less risk averse or more so, depending on who is pounding on them.

On the one hand, AIDS activists prodded the agency to develop fast-track methods for approving HIV drugs. On the other, the FDA took a highly effective drug for multiple sclerosis, called Tysabri, off the market after two people taking the drug died for unexplained reasons. People die taking drugs all the time and are more likely to suffer serious side effects from aspirin or RU-486 than Tysabri. But Tysabri was yanked off the market for a year because the deaths happened to be reported the very day that the Senate was holding hearings on the safety of Vioxx.

To suggest that putting holds on nominations will insulate the FDA from politics is absurd. On the contrary, of all the tools of intimidation against the agency, they are most abused and deployed for the least important issues. Neither Mrs. Clinton -- nor any other politician for that matter -- placed a hold on Dr. von Eschenbach's nomination until the FDA ruled on Tysabri, or decided to approve the latest drug for a rare disease. Mrs. Clinton and Sen. Tom Coburn (who placed a hold on the nomination of the previous commissioner until the FDA put new warning labels on condoms) have crossed the line.

The principle Mrs. Clinton says she supports (to let the FDA decide whether something is safe and effective and provide the facts to a public that can decide when and if to use the product) makes sense. It's the best way to insulate public-health decisions from political pressure or FDA response to that pressure. But the only way to protect scientific decisions from undue political stress is to increase the ability of the agency to make and implement decisions using the best science possible. And the agency needs to develop systems for tracking outcomes and giving patients better information about proper use, rather than denying a product because a small group may be at greater risk than the vast majority.

The FDA needs to do more of this so-called risk management work and Plan B could be released under such an approach. But it's not in a politician's interest to give the agency the ability to empower consumers. Second-guessing the FDA is a great career builder: Note the behavior of Mrs. Clinton, Rep. Henry Waxman and Sen. Charles Grassley, among others. They are all about show trials, second-guessing specific agency decisions or extorting some action or another. But when it comes to providing the FDA the tools and mandate to promote personalized medicine and consumer choice, they are nowhere to be found.

In the short term, people on both sides of the Plan B issue should stop using the FDA as a staging area for political foolishness. There is no solution to the Plan B stalemate except a strong commissioner who can build consensus and commit to a decision. The long-term holding of scientific appointments hostage to obtain a political outcome is not good government and worse public-health policy. It enslaves a science-based agency to the whims of media-hungry pols. It's time to substitute real science for junk politics at the FDA once and for all.

Robert Goldberg is vice president for strategic initiatives for the Center for Medicine in the Public Interest.