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Life Sciences; person looking into microscopeIt is increasingly understood that people of different sexes respond differently to disease, and indeed, to therapies and medical devices intended to treat disease. COVID-19 is the perfect example, as it has been widely reported that men have more severe reactions than women. See The Coronavirus Affects Women and Men Differently—Learning How May Help Stop the Pandemic, Yale School of Medicine, June 17, 2020. Historically, clinical trials for drugs often disproportionately studied men, thereby limiting data on potential sex-related differences. Steps are being taken to remedy this. For example, FDA has recently issued guidance targeted at encouraging inclusivity in clinical trials to help. See FDA Offers Guidance To Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development, FDA Statement, Nov. 9, 2020. Although the guidance will be helpful in identifying sex-related safety signals pre-market, for pharmaceuticals, we are still forced to grapple with, and reconcile, sex-related safety signals that emerge for drugs that are currently on the market.

For FDA, post-market sex-related safety signals have been a recent area of focus. In November 2018, FDA declared its intention to be the world leader in identifying safety signals associated with devices, and the agency stated that it would be particularly focused on devices that impact women. Since that announcement, FDA has had advisory committee meetings focused on the safety of surgical mesh and breast implants, and it has asked one company to voluntarily recall certain textured breast implants. See FDA Press Release on Recall of Certain Breast Implants, July 24, 2019 (Recall of Implants). Curiously, though, FDA’s request for the recall of textured implants came little more than two months after FDA announced that despite recalls of textured implants in other countries, there was not sufficient scientific evidence of safety issues to warrant a recall in the United States. See FDA Statement on New Efforts To Ensure the Safety of Breast Implants, May 2, 2019. FDA justified its change of course based only on new adverse event reports, which are notorious for their inability to establish causation. See Recall of Implants, supra. FDA has also been focused on post-market safety signals in drugs. For example, in October 2020, FDA issued a drug safety communication for use of NSAIDs by pregnant women—a particularly understudied population. See FDA Warns That Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications, FDA News Release, Oct. 15, 2020.

With this new focus on women’s health products, it is important for companies marketing such products to have tools that help them better understand safety signals associated with such products. Epidemiology is the best tool we have to help us sort real safety concerns from the noise.

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