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Gaps are found in FDA data Drug oversight system found seriously flawed.


WASHINGTON -- Deficiencies in the Food and Drug Administration's system of approving and monitoring over-the-counter drugs have left it with little data on the number and types of adverse reactions and virtually no system of obtaining any, according to a General Accounting Office study.

The report, to be released today by a subcommittee of the House Small Business Committee, noted that some over-the-counter drugs were known to cause serious problems under some conditions. For example, aspirin can cause internal bleeding.

The report said these known effects suggest that there may be others that are unknown, especially if two or more drugs are taken.

Although there may be as many as 300,000 over-the-counter or non-prescription drugs on store shelves, manufacturers are not required to report adverse effects or to turn other information to the agency as they are with prescription drugs.

Non-prescription drugs include anything that has a biological effect on the body including, for example, deodorants with ingredients that act on the sweat glands.

The GAO, an investigative arm of Congress, found that the Food and Drug Administration had not even been able to determine the exact number of over-the-counter drugs being sold in the country, let alone evaluate problems associated with them.

In its review of medical literature and other reports, the GAO office said, "we found numerous examples of the health hazards that can be associated with the use and abuse of widely used OTC drugs."

Many of these problems were associated with user abuse or the effects of using multiple drugs, it said.

Rep. Ron Wyden, D-Ore. and chairman of the subcommittee on Regulation, Business Opportunities and Energy, which requested the report, said in a letter sent with the study to the FDA that regulatory deficiencies may result in greater problems for consumers as more drugs go on the market, including drugs that are changed from prescription to over-the-counter status.

Mr. Wyden suggested that a more rigorous review and monitoring system, similar to what is in place to regulate prescription drugs before and after marketing, might help consumers, who are increasingly turning to self-medication to reduce health-care costs. He plans to hold hearings in March on federal regulations for over-the-counter drugs.

"I believe the GAO has identified serious deficiencies which need swift correction," Mr. Wyden said in the letter to Dr. David Kessler, the FDA commissioner.

Sharon Snider, an FDA spokeswoman, said the agency would not comment until the report had been studied.

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