FDA Issues New Guidelines For Conducting Pregnancy Drug Safety Studies

Federal regulators are proposing new, broader guidelines for conducting clinical trials involving pregnant women, which are designed to protect the safety of mothers and unborn children.

The FDA proposed draft guidance last month, “Postapproval Pregnancy Safety Studies Guidance for Industry”, which offers recommendations for the drug industry on how to design studies to assess the effects of medications on pregnant women. The agency says it released the guidance due to the lack of extensive research into the potential risk of drugs on fetuses and women during pregnancy.

Researchers recognize there are limitations to conduction studies on pregnant women, since the concerns of fetal safety during pregnancy typically preclude manufacturers from conducting these studies. Yet, there is a benefit to determining if some drugs are necessary, less or more effective during pregnancy, or if there are alternatives to standard of care treatment.

To that end, the guidance focuses on how to design studies for pregnant women, so they can make the best choice regarding medications during pregnancy.

The guidance outlines how to design clinical studies during pregnancy. Additionally, it broadens the scope to allow researchers to use pregnancy registries, pharmacovigilance data, and other sources such as electronic data and population-based surveillance sources. The FDA indicates that it believes using broader types of data sources can be alternatives to recruiting actual pregnant women for clinical trials.

The draft guidance recommends pregnant women enroll in postmarket trials if studies on pregnant animals have been done, and if a database of safety data of the drug’s effects on non-pregnant women has been completed. Furthermore, the guidance indicates that if preliminary safety data from medical literature is also available, pregnant women can also be included in postmarket studies.

Similarly, the FDA indicates that if a woman enrolled in a clinical trial becomes pregnant she should be allowed to continue with the trial if potential benefits exist that outweigh the risks of using the drug.

Due to the extensive changes occurring during pregnancy, it may be necessary for doses of a standard drug to be increased or decreased during pregnancy. Without research data concerning these changes a clear conclusion can’t be reached as to the efficacy of certain medications, the agency noted.

FDA officials say this is why clinical data on pregnant women is necessary and why the agency is proposing the change to its regulations concerning clinical studies during pregnancy.

The draft guidance is open for comment from the public for 29 days from issuance. Comments can be submitted to the FDA electronically via the Federal eRulemaking Portal or in writing by July 8. Written submission should be mailed to 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.