FDA unaware of most drug complaints

The Food and Drug Administration receives more than 300,000 reports annually about adverse effects caused by drugs on the market, but officials say those reports don’t include most patients’ concerns because local health care professionals are not required to report complaints to the federal level.

“We’ve always estimated we get about 10 percent of all reports,” said Dr. Paul Seligman, director of the FDA’s Office of Pharmacoepidemiolgy and Statistical Science.

A Harvard study two years ago, published in the Journal of the American Medical Association, cited previous research that estimated only 10 percent of serious adverse effects are given to the FDA through its MedWatch program.

MedWatch is the voluntary system the FDA established in 1993 for health professionals to report serious adverse reactions and problems related to drugs, biologics, medical devices, dietary supplements, cosmetics and infant formulas. MedWatch followed another FDA voluntary-reporting program started in 1961.

Pharmaceutical firms are required to report adverse effects to the FDA.

“Ninety percent of the reports we receive about the most adverse effects come from manufacturers,” said Dr. Seligman, noting that many doctors and pharmacists first report such complaints to manufacturers.

Dr. Gregory A. Thompson, director of the Los Angeles County-University of Southern California Drug Information Center, which advises health care professionals about proper dosages and side effects of medications, said the proportion of serious drug complications voluntarily reported to the FDA is “far lower” than 10 percent.

“[Health professionals] might report 10 percent of people who die of serious side effects of drugs,” Dr. Thompson said. He stressed that there should be more reporting, noting that the hospital where he works ?? the USC Medical Center ?? “reports hundreds of serious complaints yearly” to the FDA.

The 2002 Harvard study in JAMA found that one in five new drugs produced major side effects that were not discovered until after FDA approval.

The FDA says no one should be surprised that it’s not until a drug has been taken by hundreds of thousands — or millions — of people that some complications are discovered.

One person trying to get Congress to require physicians to report adverse events after drug approval is Marvin Moskowitz, 76, of Lancaster, Calif. He said he took a drug for heartburn and developed an unwanted condition.

“Tissue developed under my breasts, and I wanted someone to help me with the $9,000 medical bills I incurred,” he said.

Asked about Mr. Moskowitz’s push for federal legislation that would require physicians to report to the FDA “all serious side effects and complications,” Dr. Seligman said, “the practice of medicine is regulated on a state-by-state basis. The FDA has no legal authority over health care providers, only manufacturers.”

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