Drugs

FDA Not Yet Implementing OTC Drug Reforms: GAO

A Government Accountability Office (GAO) review of FDA’s over-the-counter (OTC) drug monograph program performance based on enhancements provided by Congress in the 2020 CARES Act says that the agency has not begun receiving any OTC monograph order requests, and they do not expect to do so until October at the earliest. GAO says that the CARES Act provided 18 months of exclusivity to requestors for certain types of OTC monograph changes made as a result of a monograph order request. OTC monograph drug exclusivity is available for an active ingredient change or a change in a drug’s conditions of use based on data from human studies.

GAO notes that FDA is currently implementing OTC monograph reform, including the provisions related to exclusivity. It says an agency goals document anticipated that the first three years of implementing OTC monograph reform would involve developing the infrastructure to carry out monograph enhancements. “This includes hiring and training staff, developing guidance for agency staff and industry, and constructing information technology (IT) platforms to, among other things, facilitate the review of OTC monograph order requests,” it says. “In addition, during this time, the agency expected that its capacity for reviewing OTC monograph order requests would be consumed by other monograph mandates and safety activities.”

Additionally, FDA officials told GAO that they have begun recently to develop the preliminary procedures needed to review OTC monograph order requests. “Officials also told us that FDA is developing procedures related to how the agency will implement OTC monograph drug exclusivity,” GAO says.

Industry stakeholders interviewed by GAO said a “handful” of companies are actively considering submitting an OTC monograph order request and are “enthusiastic over the prospect of an 18-month period of exclusivity,” the government auditor says. “However, industry stakeholders said the submissions may not occur until 2024. According to the potential timeframes described in the agency’s May 2020 informational briefing on monograph reform, FDA estimates an OTC monograph order request review would take 17 to 23 months before the agency could finalize a monograph change, including one related to exclusivity.”

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