In The News

Life Sciences Partner Quoted in The Pink Sheet and Bloomberg BNA on One-Year Delay in FDA Off-Label Product Rules

Practices: FDA Regulatory, Life Sciences

In March 17 – 18 articles in Bloomberg BNA’s Health Care Daily Report and The Pink Sheet, life sciences partner Kellie Combs (Washington, D.C.) is quoted on the one-year delay concerning the effective date of the U.S. Food and Drug Administration (FDA’s) new intended use rule, which addresses the evidence the government can consider when determining whether a drug or medical device manufacturer can be held liable for off-label promotion.

In the March 17 – 18 articles Ms. Combs explained that FDA delayed the effective date in response to a citizen petition jointly filed by the Medical Information Working Group, the Pharmaceutical Research and Manufacturers of America, and the Biotechnology Innovation Organization. In the petition, the industry groups argued that FDA overstepped its authority and failed to follow proper procedures in issuing the rule.

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