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FDA Publishes "Drug Safety Newsletter" Following Criticism of Its Oversight

Sep 19, 2007 | Parker Waichman LLP, LLP

Reeling from criticism that it doesn’t do enough to protect the public from defective drugs, the Food & Drug Administration (FDA) has started to publish a “drug safety newsletter”.   The FDA said the new quarterly publication is part of an ongoing effort to keep the medical community informed about drug safety issues.

The newsletter is part of the FDA response to savage criticism it received in a report published last year by the Institute of Medicine that faulted the agency’s drug safety record.   The report cited the FDA’s apparent inability to pass on critical safety information on marketed drugs to healthcare providers in a timely and efficient manner.   Every year, the FDA receives more than 400,000 reports of adverse drug side effects, but the Institute of Medicine said that the FDA’s “dysfunctional” structure hampered the release of such information.

The FDA said the newsletter is an attempt to rectify that problem.   In announcing the newsletter, FDA Commissioner Andrew Von Eschenbach said that “knowledge not communicated is almost invariably knowledge wasted.”    He added that “this is invariably true about the the wealth of data that are developed or received by our agency about the safety of new or widely used medications.”  Von Eschenbach said that the newsletter would keep the medical community informed of post marketing drug safety reviews, drug safety issues and recently approved medications.

While the newsletter is an obvious attempt to counter the Institute of Medicine’s criticisms, it is a far cry from some of the major policy changes the Institute’s report advocated.  That report said the FDA’s drug approval and safety review mechanisms were in serious disrepair.  Among its recommendations was the institution of a moratorium on consumer advertising on newly approved classes of drugs until they were on the market long enough for their safety to be adequately gauged.  The report also recommended that such drugs be marked with a label so that consumers would know that a medication’s safety profile was not fully known.  The Institute also called on the FDA to review new drugs after they were on the market for five years.

But much of the Institute’s criticism focused on a central gap in FDA drug oversight.  While the agency insists on strict data showing safety and effectiveness in clinical trials before it will approve a drug, the report faulted the agency for paying too little attention to drugs after they are put on the market.  As a result, the FDA reacts slowly when safety issues arise after approval. Medical providers and patients are then left confused about a drug’s potential side effects.   The FDA is hoping that its newsletter will help the agency address this problem.



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