Regulatory Implications Of The CARES Act On Over The Counter Drugs

Pharmaceutical Online - Suzanne O'Shea, Saul Helman, David Berger, and Jody Roth

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The Coronavirus Aid, Relief, and Economic Security (CARES) Act, passed in March of 2020 in response to the COVID-19 pandemic, reforms how over the counter (OTC) drugs are regulated in the United States. In announcing the legislation, the FDA called the changes a “landmark step that will have an impact lasting long after the current public health emergency.”

One clear intent of the CARES Act was to “wrap-up” the old OTC monograph process as quickly as possible. To that end, the new law deems products at various stages of review under the old OTC monograph system to be generally recognized as safe and effective, new drugs requiring an approved new drug application (NDA), or products that may be marketed without an approved NDA.

The CARES Act Creates Options For OTC Drug Manufacturers

Among other things, the CARES Act creates an administrative order process to replace the old OTC drug monograph system. Under the new administrative order system, manufacturers wishing to bring an OTC drug comprised of active ingredient not currently marketed OTC may request the FDA to issue an administrative order permitting the marketing of the product without the need for an approved NDA.

However, the CARES Act states that the law shall not preclude a person from seeking approval of an NDA. We understand this statutory provision to mean that manufacturers have the option of seeking an administrative order or NDA approval.

In this article, we discuss factors manufacturers of new OTC drug products may wish to consider in deciding which regulatory route to follow.

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