FDA Official Sees Need for Changes to Over-the-Counter Drug Regulation

A Q&A with Janet Woodcock, director of the Center for Drug Evaluation and Research

FDA Official Sees Need for Changes to Over-the-Counter Drug Regulation


Americans routinely use over-the-counter (OTC) drugs to treat a wide variety of ailments, but the Food and Drug Administration’s system for regulating most of these medications is unable to respond quickly to consumer safety concerns. That’s because updating or changing an OTC product’s FDA-approved recipe—known as a monograph—requires notice and comment rule-making, an overly burdensome and often years-long process for the agency and drugmakers. The Pew Charitable Trusts’ health care products project has been working with federal policymakers, industry groups, and other public health organizations to enact legislation that improves the current regulatory framework.

Dr. Janet Woodcock directs FDA’s Center for Drug Evaluation and Research, the division responsible for evaluating prescription and OTC drugs before they can be sold. Woodcock has testified before Congress on the importance of reforming the out-of-date OTC monograph system. She recently discussed why reform is an agency priority for both government efficiency and public health.

Janet Woodcock

Q. From FDA’s perspective, why is reform of over-the-counter drug regulation important?

A. Over-the-counter drugs play an increasingly vital role in America’s health care system. Although the current system has provided consumers with access to a wide variety of OTC drugs for decades, these products have become more challenging to regulate scientifically, and the regulatory framework for OTC monograph drug products has become increasingly difficult to administer. Regulation of these drugs relies on a three-step rule-making process established in the 1970s. The weaknesses include extremely lengthy, multistep rule-makings to establish or amend the monographs, even when addressing significant safety issues, as well as limitations on what new products can be marketed under the OTC monograph drug review. It is time to re-examine the OTC regulatory process to provide a more timely and efficient process that addresses urgent safety issues and keeps pace with innovation.

Monograph reform would streamline the process of issuing or amending monographs by converting the current rule-making process to one based on administrative orders, which would improve efficiency, timeliness, and predictability. It would also establish a process to address safety issues rapidly and enable us to finalize many pending monographs and create a pathway for new OTC drug products that promotes choice for consumers and facilitates innovation. In addition, the FDA has discussed user fees with industry to provide resources necessary to implement and sustain the anticipated policy reforms and their benefits.

Q. Why do you think this issue is getting traction now?

A. Senator Lamar Alexander [R-TN], chair of the U.S. Senate Committee on Health, Education, Labor, and Pensions, asked the FDA for ideas about monograph reform in April 2015 during a committee hearing on medical product innovation.

The FDA has taken several steps to engage the public on how to reform the OTC monograph drug review process. In March 2014, the agency held a public meeting to receive comments and input from stakeholders, consumers, and industry. FDA also has engaged in monograph reform and user fee discussions with the Consumer Healthcare Products Association and other industry stakeholders. We’ve held exploratory meetings with consumer, patient, health professional, and public health groups to seek stakeholder input on potential reforms. Among those we’ve met with are The Pew Charitable Trusts, American Academy of Pediatrics, American Public Health Association, Alliance for Aging Research, AARP, Public Citizen, Consumers Union, National Center for Health Research, National Association of Chain Drug Stores, and others. In June 2016, we held a public meeting to discuss potential monograph user fees, followed by a webinar on the topic that September. We’ve also engaged with members of Congress on the issue.

Stakeholders from this wide range of interests support reforms to streamline and improve the timeliness of review activities, spur innovation on behalf of consumers, and enable the agency to better respond to urgent safety issues. FDA agrees that these changes would better protect the public health.

Q. If reform doesn’t happen soon, what does the future of over-the-counter drug regulation look like?

A. Without the passage of monograph reform legislation, the shortcomings of the existing, out-of-date monograph system will continue and worsen. Challenges in accommodating innovation and keeping pace with evolving science will remain. We will also continue experiencing delays in completing safety and effectiveness reviews of OTC monograph drugs and responding to urgent safety issues.

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OTC products
Fact Sheet

Regulation of Over-the-Counter Drug Products Should Be Streamlined

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Fact Sheet

Americans routinely reach for over-the-counter (OTC) drugs to treat a wide variety of ailments. And they have a growing number of choices at their local drugstore: The OTC market now includes more than 300,000 products with annual sales of $32 billion. The items are diverse, ranging from antiperspirants and sunscreens to cough and cold medications and pain relievers.