FDA Wants Better Pregnancy Safety Data on Approved Drugs

The FDA on Friday issued guidance for manufacturers collecting postmarketing data on the safety of approved drugs and biologics in pregnancy, with the goal of better understanding potential risks for the pregnant patient and fetus.

“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,” Tracy Beth Hoeg, MD, PhD, the agency’s top drug regulator, said in a press release. “This guidance provides specific recommendations about how postmarketing data can be leveraged and studies can be designed so clinicians and the public can be better informed about product safety and pregnancy-related risks can be more promptly identified.”

The guidelines address three distinct scenarios — drug exposure prior to pregnancy, drug exposure during pregnancy, and postpartum monitoring — and come on the heels of a 2-day public workshop on optimizing pregnancy registries for evaluating the safety of drugs and biologics.

Although observational studies such as pregnancy registries can provide useful information, “because of the recurring challenges of achieving sufficient enrollment, pregnancy registries are often not sufficient by themselves to assess the safety of drugs used during pregnancy; therefore, other study designs and data sources capable of adequately assessing the occurrence of pregnancy outcomes are used.”

The guidance, which finalizes a draft first issued in 2019, explains three different approaches — case reports and case series, prospective primary data collection through pregnancy registries, and complementary data sources — that manufacturers can use in the postmarketing phase to evaluate safety of use during pregnancy. However, the authors cautioned, “These approaches are not intended to imply a hierarchy of evidence from the different study methods.”

HHS Secretary Robert F. Kennedy Jr. has previously expressed concern about the use of certain drugs in pregnancy — including acetaminophen (Tylenol) and selective serotonin reuptake inhibitors (SSRIs) — citing without evidence that the products could be tied to autism or other fetal harms.

Kennedy, who recently launched a deprescribing initiative for antidepressants, reportedly has been exploring the possibility of banning SSRIs. And the AP reported earlier this year that Hoeg had been working to hire a researcher and friend who has been petitioning the FDA to add warnings to SSRIs about unproven pregnancy risks, including miscarriages and fetal brain abnormalities.