- The Washington Times - Tuesday, September 28, 2010

ANALYSIS/OPINION:

The Food and Drug Administration (FDA), the nation’s most ubiquitous regulatory agency, increasingly has become not only excessively regulatory but also highly unpredictable and arbitrary - a triple whammy for companies that must gain government approval before marketing new drugs. Twice within the past few months, the FDA has backtracked on dubious, brash decisions, leading to confusion and a general lack of confidence in regulators.

In August, the FDA announced its intention to withdraw the drug midodrine from the market because “neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.” The drug had been approved in 1996 via “accelerated approval,” an abbreviated process for serious or life-threatening illnesses, to treat orthostatic hypotension - a drop in blood pressure causing dizziness and sometimes fainting when a person goes from a lying or sitting position to standing. Accelerated approvals can be based on clinical trials that show an improvement only on a preliminary, tentative endpoint. The drug’s sponsor must then perform confirmatory trials to prove that the medicine is effective in meeting a definitive endpoint, at which time the approval is converted to a standard, unconditional approval. If the studies fail to provide such confirmation, the FDA can pull the drug from the market.

But after many of the 100,000 patients who fill prescriptions annually for midodrine complained to the FDA about the prospect of losing access to the drug, the FDA said on Sept. 2 that it had reconsidered and would continue to allow midodrine to be sold. Interestingly, the announcement of the agency’s reversal came only after inquiries by the New York Times.

There’s an old saying that the plural of “anecdote” is not “data,” so this backtracking solely on the basis of a public outcry, by an agency that prides itself on acting on scientific evidence, is troubling. It does not inspire confidence.

The other recent example of FDA’s waffling has potentially greater consequences.

In March, the FDA asked pediatricians to stop administering Rotarix, a vaccine made by GlaxoSmithKline that prevents rotavirus infection, a diarrheal illness that can cause severe dehydration. The rationale was that small amounts of DNA from a pig virus have been detected in the vaccine preparation.

That might sound like a good reason for concern - except that the FDA itself confirmed “that the material has been present since the early stages of product development, including during clinical studies.” In other words, all of the studies that confirmed the safety and efficacy of the vaccine were performed with the viral DNA present. Moreover, FDA averred that “extensive studies, including placebo-controlled, randomized clinical studies involving tens of thousands of vaccine recipients, support the safety and effectiveness of the vaccine.” The head of the agency, Dr. Margaret Hamburg, said, “We’re not taking this action on the basis of a safety concern.”

Finally, consider this: The virus is commonly consumed in pork products and does not cause disease in any known host, including humans. One must wonder, then, what the problem was that FDA was trying to fix by interrupting the use of this vaccine.

But the plot gets thicker. FDA thought it could get away with its action because, well, it thinks it can get away with anything these days. Its Obama-appointed general counsel has as much as said so. Also, regulators knew an alternative vaccine, RotaTeq, produced by Merck, was available, so children would not go unvaccinated. However, Merck soon detected DNA fragments from two pig viruses in its vaccine by using a new, high-sensitivity assay.

So, having overreached and overreacted in the first instance, regulators were put in an awkward position by their risk aversion. Like Roseanne Roseannadanna, the ditzy “Saturday Night Live” character played by the late Gilda Radner, they said, “Never mind,” and rescinded the Rotarix pause.

The FDA’s bumbling over the vaccines is not without side effects. Once again, it shakes public and industry confidence in the agency’s judgment. Also, this episode surely will fuel the hysteria of the anti-vaccine activists, and some parents will be sufficiently confused that they will delay vaccinating their children. Regulators thereby have created a wholly gratuitous public health problem.

As the FDA dithers, its reputation withers.

Dr. Henry I. Miller, a physician and molecular biologist, is a fellow at Stanford University’s Hoover Institution. He was the founding director of the Office of Biotechnology at the FDA.

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