September 18, 2017

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

Holland & Knight Healthcare Blog
Michael J. Werner

On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process for over-the-counter (OTC) drug applications. This bi-partisan proposal has been in the works for several months and codifies a negotiated agreement between the regulated industry and the FDA regarding review timelines, rules on packaging and labeling, FDA performance goals, user fees, and other issues.

The bill will have far-reaching ramifications as it will impact all OTC drugs currently sold or being developed for marketing in the U.S. OTC drugs represent the vast majority of the drugs used by Americans.

The bill reforms the existing monograph process – established by FDA in the early 1970s – that relies on notice and comment rulemaking, and replace it with a system that would use administrative orders to authorize drug marketing. Similar to prescription drug and medical device review programs, it pays for the new review process by establishing a user fee program for product applicants and manufacturers. 

Importantly, the bill also contains modifications to the review process established in the Sunscreen Innovation Act (SIA) which was enacted in 2014. Despite passage of the SIA, no new OTC sunscreens have been approved by FDA for decades even though many of these products have been used safely all over the world. The new legislation will include changes agreed to by stakeholders, industry and the FDA designed to streamline the review process for sunscreen products whose applications are pending at FDA as well as for new product applications. 

Witnesses at the hearing included Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research; Dr. Bridgette Jones representing the American Academy of Pediatrics, Scott Melville, President & CEO of the Consumer Healthcare Products Association, Ms. Kristin Moore from the Pew Charitable Trusts, and Gil Roth, President of the Pharma and Biopharma Outsourcing Association.

Holland & Knight Partner Michael Werner testified on behalf of the Public Access to SunScreens (PASS) Coalition at the hearing.  PASS is a multi-stakeholder coalition comprised of public health groups, dermatologists, sunscreen manufacturers and leading advocates for skin cancer patients. The PASS Coalition was formed to ensure Americans have access to the latest sunscreen technology to curb the skin cancer epidemic in the United States. 

Congress is expected to continue working on the legislation through the fall.

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