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  1. From Our Perspective

From Our Perspective: OMUFA – Past, Current, and Future

Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Theresa Michele, M.D., Director, CDER Office of New Drugs’ Office of Nonprescription Drugs

Patrizia Cavazzoni, M.D.
CDER Director, Patrizia Cavazzoni, M.D.

Over-the-Counter (OTC) drugs have long provided an efficient, low-cost way for Americans to take care of everyday health needs, without having to visit a doctor and obtain a prescription.

Most of the OTC drugs sold in the U.S. are monograph drugs. FDA established OTC drug monographs in 1972 as a kind of "recipe book" covering acceptable ingredients, doses, formulations, labeling, and testing for OTC drugs. Products conforming to a monograph may be marketed without FDA pre-approval, while those that do not must undergo separate review and approval through the New Drug Application (NDA) process. Over time, OTC drug monographs were updated to add new ingredients and labeling as needed. However, until recently, changing monographs required a slow and lengthy rulemaking process which would often take years.

Portrait Photo of Theresa Michele
Theresa Michele, M.D.

OTC monograph reform, enacted as part of the 2020 Coronavirus Aid, Relief, and Economic Security Act, also known as the CARES Act, helped increase the efficiency, timeliness, and predictability of OTC monograph drug regulation, and streamlined safety updates. This change was accompanied by providing FDA authority to collect user fees to support OTC monograph drug activities. The OTC Monograph drug user fee program, which we refer to as “OMUFA,” is similar to our other user fee programs, such as the Prescription Drug User Fee Act (PDUFA). Under the CARES Act amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act, quicker administrative orders replace the long rulemaking process for updating OTC monographs, industry pays fees to help support our regulatory activities related to OTC monograph drugs, and FDA agrees to performance goals negotiated with industry. These performance goals include specific time frames for conducting certain OTC monograph activities.

Administrative Orders

Sometimes, FDA reviews or receives new data that may demonstrate the need to change a monograph for safety or efficacy reasons. The CARES Act amendments gave us the authority to make these changes to an OTC drug monograph using administrative orders. As FDA issues each proposed or final administrative order, we will publish the order on OTC Monographs@FDA and in the Federal Register. Publication of proposed orders will be accompanied by an open comment period where the public can weigh in on the proposed change, and we will consider these comments as we develop and issue a final order.

OMORs

Either industry or CDER can initiate the administrative order process. A request by industry to initiate the administrative order process is called an OTC Monograph Order Request (OMOR) and can be made by a requestor, which is any person or group of persons marketing, manufacturing, processing, or developing a drug. Before submitting an OMOR, FDA recommends the requestor meet with us to discuss specific data, studies, and related information that will be submitted in the OMOR.

FDA has the authority to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and requestors of OMORs to support the agency’s OTC monograph drug activities. There is an exception to this fee collection when the OMOR is to update the OTC monograph with certain safety changes.

OMUFA I Accomplishments

OTC monograph reform has benefitted patients, industry, and our nation’s health care system and has reduced regulatory burden. During the first years of the program, FDA has successfully created much of the infrastructure necessary to achieve these benefits, such as:

  • Creating a new IT system, OTC Monographs@FDA, which maintains relevant documents related to the monographs.
  • Posting an annual monograph forecast each year, which is a nonbinding list of the of planned monograph activities that FDA intends to initiate over the next three years.
  • Posting all 33 OTC monograph final orders deemed established by law upon enactment of OTC monograph reform, which set forth conditions under which OTC monograph drugs in certain therapeutic categories are generally recognized as safe and effective (GRASE).
  • Meeting all performance goals for formal meetings between FDA and industry.
  • Expanding the CDER NextGen Portal to enable certain electronic OTC monograph submissions.
  • Issuing five draft guidances.
  • Finalizing the guidance, “Providing Over-the-Counter Monograph Submissions in Electronic Format.”

In addition, FDA published two proposed orders - the first was an FDA-initiated proposed order to address a safety issue related to OTC monograph drug products containing acetaminophen. This proposed order, if finalized, would require drug companies to add a warning to the labeling of these products to alert consumers that the use of acetaminophen may cause severe skin reactions. The second proposed order was an FDA-initiated order to amend the relevant OTC monograph to remove oral phenylephrine as an active ingredient for the temporary relief of nasal congestion because it is not effective. Before making the decisions to issue this proposed order, we held an advisory committee meeting on this issue and informed the public of our intent to publish this order in the annual monograph forecast. We also published a proposed order to amend the sunscreen monograph, as was required by the CARES Act.

OMUFA II Negotiations

The current legislative authority for OMUFA expires September 30, 2025. At that time, Congress will have to reauthorize the OMUFA program in order to continue the program for future fiscal years. As it does for several other user fee programs, FDA is required by law to engage in negotiations with industry to develop recommendations to reauthorize OMUFA for fiscal years 2026 through 2030, i.e., OMUFA II. As part of the reauthorization process, FDA held a public meeting on September 28, 2023, to obtain the perspective of scientific and academic experts, health care professionals, patients, consumers, and regulated industry on OMUFA reauthorization. FDA will host a second and final public meeting on November 20, 2024, to solicit feedback on the OMUFA II commitment letter (a document that generally outlines goals and timeframes agreed to by FDA and industry for specified OTC monograph drug activities), as well as other elements of the OMUFA reauthorization recommendations. We invite public comment on the OMUFA reauthorization recommendations, through a docket (FDA-2023-N-3575) open until December 20, 2024.

Additional Information

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