Emergency Relief Package Yields Increased FDA Funding, OTC Revisions

March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how the agency will review over-the-counter (OTC) drugs moving forward.

These provisions of the bill will enable FDA to streamline its processes while maintaining its regulatory authority over and approval of drugs and other medical products.

“With the coronavirus pandemic have come calls by some politicians and opinion writers to ‘simplify’ FDA approval processes and ‘reduce red tape,’” noted Coalition for Healthcare Communication Executive Director Jon Bigelow. “Unfortunately, those calls represent poor understanding of the critical role the FDA’s approval procedures play in safeguarding Americans’ health,” he said.

The $2 trillion legislation earmarks $80 million for the FDA “to prevent, prepare for, and respond to coronavirus, domestically or internationally, including funds for the development of necessary medical countermeasures and vaccines, advanced manufacturing for medical products, the monitoring of medical product supply chains, and related administrative activities,” which adds to the $61 million designated for the same purpose in earlier pandemic relief legislation.

The new legislation also will enable the FDA to revise and strengthen its regulatory oversight of OTC products and collect user fees for product reviews. OTC products currently represent more than half of the medicines on the market in the United States, and the FDA’s current oversight has been limited to post-market actions. Additionally, a provision for faster reviews of new and innovative ingredients for OTC sunscreen products was slipped into the legislation.

“We are very pleased to see that included in the emergency relief bill are measures that will strengthen the FDA in two ways,” according to Bigelow. “One way is by giving the FDA authority for and a funding mechanism to establish more stringent reviews of new OTC products and flexibility in update OTC product monographs. The second way is by providing – between the first and second relief packages – an additional $141 million in funding for FDA activities in responding to the coronavirus pandemic.”