ORLANDO, Fla. — The U.S. Food and Drug Administration issued final guidance Thursday aimed at improving how pregnancy safety data is collected for drugs and biological products after they are approved.
The guidance, titled Postapproval Pregnancy Safety Studies, gives drug and biologics manufacturers recommendations for studying how products may affect pregnant patients and developing fetuses once those products are on the market.
FDA officials said many pregnant women may need medications to treat ongoing or new health conditions, but there is often limited human data available about a product’s safety during pregnancy at the time it is approved.
“Pregnant women and their healthcare providers need clear, reliable information to make informed treatment decisions,” FDA Commissioner Dr. Marty Makary said in a statement. “This guidance supports better ways to collect safety data, so clinicians have more useful information when counseling patients during pregnancy.”
The FDA said pregnancy safety studies may require input from experts in obstetrics, pediatrics, genetics and statistics.
The guidance outlines several methods for collecting pregnancy safety information, including pregnancy registries, studies using real-world data, and descriptive studies based on individual case reports.
FDA officials said the goal is to generate information that can be added to drug labeling so health care providers and patients can better understand potential risks and make informed decisions.
“Currently many medical products may be recommended to pregnant women by healthcare providers in spite of the fact that data from the clinical trials used for FDA approval were insufficient to assess safety during pregnancy,” said Dr. Tracy Beth Hoeg, acting director of the FDA’s Center for Drug Evaluation and Research.
Hoeg said the guidance provides recommendations for using post-market data and designing studies to more quickly identify pregnancy-related risks.
The FDA said its guidance documents reflect the agency’s current thinking and do not create legally enforceable requirements.
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