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Adverse event reporting tightens for OTCs and dietary supplements

The packagers of over-the-counter drugs (OTC) and dietary supplements will soon need to label their products with contact information to allow consumers to report possible injuries or illnesses. The packagers, in turn, will have to report serious adverse events to the Food and Drug Administration, and keep records of the events. The law goes into effect December 22, 2007.

This law, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, is designed to increase reporting of serious product problems. Labels will have to feature a U.S. address or phone number to which reports of serious adverse events can be directed.

These reports to the FDA are required to be made using the existing MedWatch reporting form, along with a copy of the product's retail package label. MedWatch is the FDA's Safety Information and Adverse Event Reporting Program that provides information about safety issues involving medical products, including prescription and OTC drugs, biologics, medical and radiation-emitting devices, and special nutritional products.

The law protects companies from civil lawsuits that might arise from the information in the reports. Submission of any report required by the law "shall not be construed as an admission" that the product caused or contributed to the adverse event. Personally identifiable information in any of the records would also be redacted.

The law also contains explicit preemption provisions that prohibit state or local governments from making any requirement relating to mandatory adverse event reporting that is in addition to, or different from, this new federal system.

OTC drug and dietary supplement trade groups both support the legislation.

--Eric Greenberg, Attorney-at-Law
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