Promised tests remain undone for many FDA-approved drugs

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Promised tests remain undone for many FDA-approved drugs

By Gardiner Harris
NEW YORK TIMES NEWS SERVICE

March 4, 2006

WASHINGTON – When the Food and Drug Administration approves new drugs for sale, it often requires their manufacturers to study whether the medicines are working as intended and whether they have unwanted side effects. But yesterday, the agency reported that two-thirds of the studies hadn't even been started.

Hundreds of studies have been pending for years, with one dating to 1955, the FDA said. In many cases, pharmaceutical makers promised to undertake the studies as a way of speeding their drugs' approval. The FDA said yesterday that drug companies had pledged to conduct 1,231 drug studies. But 797 – or 65 percent – had not begun or were “pending” as of Sept. 30. Critics of the industry promptly seized on the new numbers, saying they demonstrate that the FDA needs more power to compel drug makers to follow through on needed studies.

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One problem is that the promised studies are often difficult to complete. For example, few cancer patients would willingly risk enrolling in a study that might result in them receiving a placebo when the active drug is easily available at any oncologist's office. As a result, just one cancer medicine in five has ever proved that it extends patients' lives – the usual endpoint demanded of post-approval cancer trials.

The promised trials are also expensive, and drug makers sometimes have few incentives to complete them. The FDA's only recourse in such a case is to withdraw the drug, but because such a step might hurt patients, it's considered so Draconian that regulators have never taken it over a failure to complete a study.

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