FDA draft guidance seeks better safety data for pregnant women

By | May 13, 2019

The Food and Drug Administration is proposing recommendations on how to better design studies to assess pregnancy outcomes in women exposed to FDA-regulated drugs and biological products.

The new guidance includes sections on obtaining information from databases and electronic health records systems.

According to the agency, its recommendations replace 2002 guidance issued to industry—which has been withdrawn—and are consistent with the most up-to-date protocol specifications and scientific standards for pregnancy safety studies.

“Currently, collection of safety data in drugs and biological products used during pregnancy usually occurs after approval,” states the FDA’s notice in the Federal Register. “Pregnancy registries have been used to collect these data. However, in the years since FDA first issued guidance on this topic, scientific methodologies for assessing safety in pregnancy in the post-marketing setting have evolved.”

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The FDA’s recommendations include a broader scope of methods for collection of safety information for drug and biological products used during pregnancy, including pharmacovigilance activities and other post-approval safety studies.

Specifically, the Postapproval Pregnancy Safety Studies draft guidance broadens the scope of methods to include “database studies such as claims or electronic health records, case-control studies, population-based surveillance” and other kinds of pharmacovigilance activities, said Principal Deputy Commissioner Amy Abernethy, MD, and Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a written statement.

“The recommendations in this draft guidance reflect discussions and recommendations received during a two-day workshop convened by the FDA in 2014, Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting, as well as FDA review” of pregnancy registries, including assessment of pregnancy registry methods and enrollment, added Abernethy and Woodcock.

The FDA is accepting public comments on the agency’s draft guidance through July 8.


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