On December 12, FDA held a meeting of its Drug Safety and Risk Management (“DSaRM”) Advisory Committee regarding development of a framework for addressing what risk evaluation and mitigation strategies (“REMS”) are appropriate for teratogenic drugs. Teratogenic drugs are drugs that may cause birth defects for developing fetuses. The Food and Drug Administration Amendments Act (“FDAAA”) requires FDA to bring to the DSaRM Advisory Committee for review at least one drug with Elements to Assure Safe Use (“ETASU”), and this was the topic chosen for 2012.
According to the opening remarks, FDA has recognized that over the years, its approach regarding the development of risk management programs for teratogenic drugs “appears to be inconsistent.” The DSaRM Advisory Committee began with FDA presentations, continued with stakeholder presentations from industry, prescribers, patients, and then ended with the full committee’s discussion of the questions to address:
FDA’s proposed framework would take as intrinsic factors: (1) scientific evidence of teratogenicity (biological plausibility, non-clinical data, and human data) and (2) drug-product related factors (characteristic of the drug product, efficacy, and safety profile). The proposed extrinsic factors to consider in the framework are (1) drug product-related factors (actual drug use), (2) clinical-use related factors (characteristics of medical condition, patient population profile, and context of care), (3) regulatory factors (regulatory precedent, previous REMS experience, availability of new REMS tools), and (4) anticipated consequences of REMS.