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Enforcing Post-Marketing Requirements

By Alan Minsk and Diana Cohen
September 25, 2012

A recent Food and Drug Administration (FDA) Warning Letter suggests that the agency will not hesitate, when necessary, to exercise its power to enforce post-marketing requirements (PMRs) for approved drug products. (The Warning Letter is available at www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm293490.htm. While the Warning Letter is available publicly, we will not disclose here the company that received the correspondence.) The Warning Letter states that the recipient company failed to submit a required study protocol and final study report, pursuant to the company's PMRs and, therefore, the drug products are misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. ' 352(z)). The Warning Letter is significant, because it demonstrates that the agency will take enforcement action against a company for failure to comply with PMRs, creating yet another area of enforcement that can lead to cascading effects, such as increased product liability exposure, for the recipient company.

Drawing FDA reproach for failure to comply with the FDCA is bad enough, but, due to their public availability, FDA enforcement letters also increase a company's potential liability exposure. The FDA posts such enforcement letters on its website, which means that anyone, including would-be plaintiffs and their attorneys, may use the findings in the letter to bolster potential product liability claims against the recipient company. In light of the FDA's apparent readiness to issue such letters, companies should take extra care to comply with PMRs and other FDA requirements, both to enhance regulatory compliance and to reduce liability risk.

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