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