Pew Seeks to Streamline Over-the-Counter Drug Regulatory Process

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Every day, Americans use a variety of over-the-counter drugs, from cough and cold medicine to pain relievers and antacids. Although most consumers believe these products are safe, their regulation is antiquated and inefficient, which can put consumers at risk and hinder innovation.

The over-the-counter drug industry makes more than 300,000 products, generating $32 billion in annual sales. As with prescription drugs, the Food and Drug Administration must be assured that these products are safe and effective before companies can market them to consumers. But that is largely where the similarities end.

With prescription drugs, FDA approves each new product. The agency has clearly defined authority as well as the flexibility to take immediate and definitive action when it has concerns about drug safety. Not so for over-the-counter drugs.

In most cases, FDA does not approve each of these drugs individually. Instead, for each therapeutic category—such as topical antimicrobial drug products, which include acne medications—it publishes a monograph. This describes acceptable ingredients for medicines within that category and provides guidance for labeling. If a manufacturer follows the instructions for a category, it can market a product without first seeking FDA approval.

To create a new monograph or update an existing one, FDA and the industry are required to undertake a lengthy bureaucratic and burdensome process. The agency must publicize its proposed change, seeking input from the public and industry multiple times. As a result, updates to monographs can take many years—or even decades—to finalize.

This is an especially troubling system when safety concerns come to light. FDA lacks the authority to swiftly alter monographs to reflect these concerns, so products can remain on the market even if they pose risks to consumers and patients.

The system hurts over-the-counter drugmakers as well, because it inhibits innovation. As companies develop new ingredients or dosage forms, such as oral or topical solutions, they must seek alterations to the product’s monograph before they can market them. Even when those modifications have been used safely and effectively in other countries, it can take years for them to be approved in the United States.

To address this outdated and inefficient framework, Pew will develop and work to implement policy recommendations that enable FDA to more efficiently regulate this industry in order to safeguard consumers.

Elizabeth Jungman directs The Pew Charitable Trusts’ public health program.