FDA Is Seeking Ideas for a “New and Improved” Process for Regulating OTC Drugs under the OTC Drug Review

By: Janet Woodcock, M.D.

When it comes to drug approval in the United States, the focus of discussion often revolves around FDA’s efforts to approve new prescription drugs. But it’s important to remember that we also regulate over-the-counter (OTC) products, including many different drugs such as pain relievers, antacids, and cough and cold medicines.

Janet WoodcockSome OTC drugs go through the same approval process used for new prescription drugs. We use a different process known as the OTC drug review or OTC monograph process, however, to evaluate the safety and effectiveness of many other OTC drug products. Frankly, that process is outdated and does not work as quickly as FDA would like. Last week we held a two-day public meeting to gather ideas from consumers, patients, health care professionals, and the companies that manufacture OTC drugs about how we can improve the OTC drug review process.

More than 300,000 OTC drug products regulated under the OTC drug review are on the market. Each is made by following an OTC drug “monograph.” A monograph provides, in part, the necessary information for the kinds and amounts of the active ingredients, their permitted uses and what manufacturers are required to include in the written consumer information listed in the Drug Facts panel on the label. FDA does not require products that meet these requirements to obtain FDA approval before being marketed to consumers.

Some of these monographs are more than 40 years old and many need to be updated. The current process involves rulemaking, and it is slow and cumbersome. For example, the rulemaking process doesn’t allow FDA to quickly require changes to OTC drugs, or to require new warnings or other label changes to products when safety concerns arise. In addition, science is advancing quickly, and new ingredients have been developed that aren’t included in the monographs.

So our public meeting to discuss ways to make a “new and improved” version of our OTC drug review was well-timed. We heard a variety of different thoughts about how we might be able to move forward. We also heard that even though we need to improve some areas of the process, some stakeholders feel that things work and should not be changed. The meeting is over, but we still want your input. Those who could not attend can offer suggestions to our Docket No. FDA–2014–N–0202 until May 12, 2014.

We’ll consider all of this valuable feedback as we move forward. And as always, we are committed to ensuring the public has access to safe and effective drugs, both prescription and over-the-counter.

Janet Woodcock, M.D., is the Director of FDA’s Center for Drug Evaluation and Research

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