New Agreement Between OND and OSE for Management of Significant Safety Issues
August 21, 2008FDA released a Memorandum of Agreement Between the Office of New Drugs (“OND”) and the Office of Surveillance and Epidemiology (“OSE”) in the Center for Drug Evaluation and Research (“CDER”) “on the management of significant safety issues associated with pending and approved drug products.”
The memorandum “clarifies the roles and responsibilities of OND and OSE in implementing CDER’s policies” and “assists FDA in implementing” certain provisions of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”). The agreement explains that both OND and OSE are “given equal weight” for their opinions on how to resolve significant drug safety issues, which include, among other issues, any safety issue that could lead to the withdrawal of a drug from the market, withdrawal of an approved indication, and changes to drug labeling.
After a safety issue is identified, OND and OSE must work together to determine the appropriate response actions. According to the memorandum, possible responses include requiring labeling changes (pursuant to FDAAA § 901, 121 Stat. 924, which created FDC Act § 505(o)(4)), “requiring a sponsor to submit and implement a [risk evaluation and mitigation strategy] REMS” (FDAAA § 901, 121 Stat. 926, which created FDC Act § 505-1), “requiring a sponsor to conduct a post-market study or clinical trial (FDAAA § 901, 121 Stat. 923, which created FDC Act §505(o)(3)), “requesting an applicant to discontinue marketing,” or other actions as determined appropriate by the two offices.
Although the memorandum explains that OND and OSE are “given equal weight,” OSE will have increased authority over safety issues. The document explains that OSE is expected to expand its role as an expert in certain fields, including pharmacovigilance activities, risk management plans, and labeling and packaging review. OSE will also became the lead office for observational epidemiologic studies and medication error prevention. As part of medical error prevention, OSE will “lead in the review of proposed proprietary names or changes to proprietary names,” which is a departure from the current model where OSE provides guidance to OND. Finally, OSE will review “protocols and studies that assess medication error risk.”
The memorandum is notable for its shift in responsibility and control for certain issues to OSE. It seems likely that OSE will have to expand its office in order to meet its new responsibilities, and it may take some time before it has adequate resources to fully accept the responsibilities.