GAO Report on Over-the-Counter Drugs

Under the Sunscreen Innovation Act (SIA), GAO was to review and report on FDA’s regulation of sunscreens and other over-the-counter (OTC) drugs.  In late July, 2020, GAO issued its report on its performance audit conducted from July 2019 through July 2020.  The report focuses on factors that affect FDA’s ability to regulate OTC drugs, how FDA identifies and handles safety issues, and the status of FDA’s implementation of the SIA.  Due to the enactment of the CARES Act in March 2020, which includes OTC monograph reform legislation which extensively overhauls the OTC program and was intended to address some of these very issues (see our blog post here), the value of the report has diminished.

The report provides a summary of the reasons often cited for the need for monograph reform and of the major relevant provisions of the CARES Act.  GAO was informed by FDA officials that the OTC monograph system limited the Agency’s responsiveness. Due to the requirement for rulemaking and insufficient resources, the Agency was hindered in updating and amending a monograph in response to safety concerns.  However, this all changed in March 2020.  As we described in our memo (an updated version of which can be found here), the new legislation reforms the monograph system to one of administrative orders.  Instead of rulemaking which would take six or more years, FDA expects that the administrative orders process can be completed in less than two years.  Moreover, the legislation established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug’s labeling to mitigate a significant or unreasonable risk of a serious adverse event.

With respect to the requirements under the SIA, GAO notes that FDA had implemented most of the required activities within the mandated time frames, except that FDA did not meet the deadline of November 2019 for a final monograph for OTC sunscreen products.  However, this requirement was eliminated under monograph reform.  That said, the comments to the proposed rule will need to be considered in FDA’s future administrative order for OTC sunscreen drug products.  As of June 2020, FDA officials told GAO that the agency had not yet completed its review of the provisions in the CARES Act that affect FDA’s regulation of OTC drugs, and, therefore, officials could not comment on the specific requirements that will be included in the newly deemed administrative order. FDA officials said the Agency did not yet have a plan or time frame for publishing the deemed administrative order for sunscreen.  GAO also included a brief description of the 15,000 comments FDA received on the proposed sunscreen rule.  FDA informed GAO that 1,100 of the comments were unique comments and more than 100 comments included extensive attachments, such as studies or technical comments.

GAO also reports that FDA officials said it will take time before FDA is able to fully realize any benefits that might result from changes in the CARES Act. For example, it generally takes two years for any newly hired FDA staff to complete training and to acquire the knowledge and experience needed to be fully effective in reviewing scientific information related to the regulation of OTC drugs.

The new monograph user fee system is intended to provide FDA with much needed resources.  However, FDA may only collect user fees in the amount provided in an appropriation act.  As of the end of July 2020, legislation providing for an appropriation for the OTC user fees has not been enacted.