Pregnancy Safety Data Collection Regulation Under Review, FDA Says
This article was originally published in The Tan Sheet
Executive Summary
A safety regulation on collecting data related to drug events in pregnant women is under review at the Office of Management & Budget.
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A safety regulation on collecting data related to drug events in pregnant women is under review at the Office of Management & Budget. "We have a new safety reporting regulation...in the [OMB] now that will specifically" indicate pregnant women as a "special population," FDA Office of Drug Evaluation IV Deputy Director Sandra Kweder, MD, said Dec. 4 at a public meeting in Washington, D.C. The meeting was held by FDA and the National Institute for Child Health & Human Development to provide an overview of clinical pharmacology in pregnancy and garner support for research among advocacy groups. The agency will use the regulation to "work with companies to get [the data] into the labeling," Kweder said. The FDAer is co-chair of the agency's Pregnancy Labeling Task Force. Kweder also predicted that while most existing registries currently are product specific and sponsored by individual companies, "we are going to see an expansion of that." The agency released a draft guidance regarding pregnancy registries in June 1999 (1 (Also see "Pregnancy Registry Recruitment Notices Should Be Cleared - FDA Guidance" - Pink Sheet, 14 Jun, 1999.)). Also speaking at the meeting, FDA Commissioner Jane Henney, MD, noted drug exposures during pregnancy provide opportunities to collect clinical pharmacology data during every trimester. Such exposures could occur "when a mother learns that she is pregnant when she is taking the drug," or in women who "require treatment for conditions or illnesses that occur during pregnancy or that were pre-existing," Henney suggested. Moreover, approved drugs may lead to inadvertent exposures during pregnancy, she continued, noting opportunities to collect data during such exposures "have often been missed or ignored." While not binding, FDA said dietary supplement manufacturers would be encouraged to create pregnancy registries on their products as well. Supplement use during pregnancy has been a topic of concern at FDA, which held a public meeting on the subject in March (2 ). |