Title III – Supporting America’s Health Care System in the Fight Against Coronavirus, Subtitle F – Over the Counter Drug Provisions

Early in the morning on Thursday, March 26, 2020, the Senate passed the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”).  On Friday, March 27, 2020, the House of Representatives also passed the CARES Act and  President Trump quickly signed it into law the same day.

In this continuing series of blogs by lawyers at Forrest Firm, P.C., we will examine the most important, relevant, and impactful provisions of the CARES Act.  Our goal is not to provide you with a granular level examination of each provision of the CARES Act, but rather to provide a macro view of the CARES Act in clear, concise, and understandable language that will enable readers to move forward with their businesses and lives with confidence.  These are trying times, and here at Forrest Firm we want these articles to support our clients, positively impact our communities, and be available to help you with questions and concerns raised by the CARES Act.

This Subtitle of the CARES Act includes a variety of amendments to statutory provisions relating to the regulation of over-the-counter drugs.  And sunscreen.

Regulation of Certain Nonprescription Drugs that are Marketed Without an Approved Drug Application.  Section 3851 of the CARES Act amends the Food, Drug, and Cosmetic Act to include a new section in Chapter V (providing for regulations of certain nonprescription drugs marketed without an approved drug application under Food, Drug, and Cosmetic Act Section 505).  

In doing so, the provision (1) reforms the regulatory process for over-the-counter drug approvals, allowing the Food and Drug Administration to make changes administratively, rather than using the full notice and comment rulemaking process under the Administrative Procedures Act and (2) encourage drug companies to research and manufacture innovative drug products by providing an 18-month period in which they will be the exclusive purveyor of a new over the counter drug developed under this process.  

Misbranding.  Section 3852 of the CARES Act amends the Federal Food, Drug, and Cosmetic Act to provide that an over the counter drug which does not comply with the requirements of its over the counter monograph (the approved method for the ingredients and manufacture of a drug) is considered misbranded and therefore prohibited from sale in interstate commerce.  

Drugs Excluded from the Over-the-Counter Drug Review.  Section 3853 of the CARES Act confirms that over the counter drugs already excluded from Food and Drug Administration review in 1972 continue to be excluded from Food and Drug Administration review.

Treatment of Sunscreen Innovation Act.  Section 3854 of the CARES Act provides that companies with pending over the counter sunscreen orders, may within 180 days of March 27, 2020 elect to either seek review under the Sunscreen Innovation Act or transition for review under the new monograph review process.  

Annual Update to Congress on Appropriate Pediatric Indication for Certain OTC Cough and Cold Drugs.  Section 3855 of the CARES Act requires the Department of Health and Human Services to update Congress on its annual efforts to evaluate the monograph for OTC cough and cold drugs for children under the age of 6 and determine the conditions under which such drugs are “generally recognized as safe and effective.”

Finding.  Section 3861 of the CARES Act finds that the fees authorized by this Subtitle F to Title III of the CARES Act will be dedicated to a Food and Drug Administration review of over-the-counter monograph drugs.

Fees Relating to Over-the-Counter Drugs.  Section 3862 of the CARES Act creates a new user fee list with respect to OTC drugs in order to enable the Food and Drug Administration to hire additional staff to ensure that the new changes for OTC drug approval have adequate agency oversight.

If you have any questions, please do not hesitate to contact Brian Bernhardt for more information.