Who's Aided by Impasse over Vote for FDA Chief?

We need Plan C.

Resident Scholar John E. Calfee
Resident Scholar John E. Calfee
You have probably heard of Plan B, a high-dose version of a standard birth-control pill that usually prevents pregnancy if taken within 24 to 72 hours after the failure of Plan A (abstinence, for example).

Plan B has been available by prescription since 1999. The manufacturer and others want it to be available over the counter without a prescription. The Food and Drug Administration has said it would like to approve Plan B for OTC sales for everyone except girls under 16.

But there's a problem. The FDA also says that making young people go through their doctors while everyone else gets exactly the same product off the shelf is unprecedented and may be incompatible with notoriously complex FDA law. Certain senators--notably New York Democrat Hillary Rodham Clinton--are furious because the last time an FDA commissioner was confirmed, just last July, they extracted a promise of quick action on OTC status for Plan B. These senators think that promise was broken when the new FDA commissioner announced a month later that the law prohibited a quick decision, and then, soon afterward, unexpectedly resigned. Critics said it was really White House pressure, not legal difficulties, that torpedoed normal FDA deliberations. Some FDA staffers have said the same thing.

Now it's time to confirm a new commissioner. President Bush has nominated the acting FDA commissioner, Andrew von Eschenbach, a distinguished cancer researcher and survivor who headed the National Cancer Institute. But Clinton and her allies won't permit a vote until Plan B is resolved, which the FDA says it cannot do until it untangles all those legal entanglements.

What are the stakes in this political standoff? Let's compare the Plan B stakes with the no-FDA-commissioner stakes.

Plan B is available by prescription everywhere. Any state that wants to make it available OTC can do so. Eight states have already done that, and Clinton's home state can, too. Whatever the FDA does about Plan B, the impact on unwanted pregnancies will be modest.

What are the stakes in getting a permanent, confirmed FDA commissioner? Here, we move from foothills to mountains.

The FDA is the sieve through which all drug development must flow. That sieve has gotten clogged because the science is racing ahead of the FDA's regulatory apparatus, something even the FDA admits. We need lots of new biomarkers to facilitate faster drug testing. Clinical trials have to be revamped to move beyond the rigid phase 1, phase 2, phase 3 model set in place decades ago. The FDA's "accelerated approval" route for new drugs treating life-threatening diseases should be expanded far beyond cancer and AIDS to encompass slow-developing fatal diseases such as Alzheimer's. Even such mundane matters as manufacturing regulations have become technologically obsolete bottlenecks to getting drugs to market faster and at less cost.

We have been without a permanent FDA commissioner for all but 18 months of the Bush presidency. An acting FDA commissioner cannot easily wield the authority and influence necessary to recharge mid-level FDA staffers while encouraging imaginative top-level careerists to implement changes that for too long have been sitting on the drawing boards.

The same thing is true of delicate negotiations for crucial public-private partnerships. These are essential for creating diagnostic tools that can modernize toxicity testing and clinical trials and that can identify which patients will benefit from or be harmed by a new drug. The FDA has begun to collaborate with the Critical Path Institute at the University of Arizona, but that is only a start.

We're stuck in a political hostage-taking game played by a small group of senators. They think their hostages are a few White House operatives and FDA political appointees trying to get their guy confirmed. But the real hostages are millions of current and future victims of Alzheimer's, cancer, multiple sclerosis, and many other illnesses waiting for scientific breakthroughs to be translated into therapeutic breakthroughs.

It's time for Plan C. Clinton and her allies should let the Senate vote on the von Eschenbach nomination. And then they should employ hearings and other legitimate congressional tools to protest what they and many others believe to be a mistaken executive-branch decision. But they have to stop holding drug-research progress hostage to politics.

John E. Calfee is a resident scholar at AEI.

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About the Author

 

John E.
Calfee
  • Economist John E. Calfee (1941-2011) studied the pharmaceutical industry and the Food and Drug Administration (FDA), along with the economics of tobacco, tort liability, and patents. He previously worked at the Federal Trade Commission's Bureau of Economics. He had also taught marketing and consumer behavior at the business schools of the University of Maryland at College Park and Boston University. While Mr. Calfee's writings are mostly on pharmaceutical markets and FDA regulation, his academic articles and opinion pieces covered a variety of topics, from patent law and tort liability to advertising and consumer information. His books include Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000) and Biotechnology and the Patent System (AEI Press, 2007). Mr. Calfee wrote regularly for AEI's Health Policy Outlook series. He testified before Congress and federal agencies on various topics, including alcohol advertising; biodefense vaccine research; international drug prices; and FDA oversight of drug safety.

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