Quote of note:

Dr. Jenkins emphasized that only 5 percent of the promised drug trials were officially considered "delayed." In many cases, trials have been pending for more than a decade but are not considered delayed because the agency never insisted on a specific timeline for the tests.

New Drugs Hit the Market, but Promised Trials Go Undone
By GARDINER HARRIS

WASHINGTON, March 3 — When it approves new drugs for sale, the Food and Drug Administration often requires their manufacturers to study whether they are working as intended and whether they have unwanted side effects. But the agency reported Friday that two-thirds of the studies had not even been started.

Hundreds of studies have been pending for years, the F.D.A. said, with one dating to 1955. In many cases, pharmaceutical makers promised to undertake the studies as a way to speed their drugs' approval.

Critics of the industry promptly seized on the new numbers, saying they demonstrated that the drug agency needed more power to compel drug makers to complete needed studies.

Representative Maurice D. Hinchey, Democrat of New York, said that while the agency insisted that it demanded that drug makers prove their medicines safe, those demands "continue to be blatantly ignored by the pharmaceutical industry."

Mr. Hinchey has introduced legislation that would authorize the agency to require drug makers to follow through on their promised commitments.

But Dr. John Jenkins, director of the Office of New Drugs at the agency, said that many drug companies who promised to undertake trials "are taking that commitment very seriously."