U.S. Rep. Michael Burgess (R-TX) led a House Energy and Commerce Health Subcommittee hearing on Wednesday to examine how best to modernize the regulation of over-the-counter (OTC) drugs that provide relief to millions of patients.
The Health subcommittee is reviewing draft legislation that would authorize a new regulatory framework for the U.S. Food and Drug Administration (FDA). Due to the current cumbersome regulatory process, the FDA has been evaluating 26 therapeutic categories of OTC drugs since the 1970s and has not yet finalized standard specifications, or monographs, for them.
Lawmakers have been working with the FDA and industry stakeholders to create a more flexible process funded by industry user fees.
Their legislative proposal, called the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017, was authored by Burgess, along with U.S Reps. Bob Latta (R-OH), Diana DeGette (D-CO), Vice Chairman Brett Guthrie (R-KY) and Ranking Member Gene Green (D-TX).
“This bipartisan proposal establishes the OTC Monograph User Fee Program and makes a number of meaningful modifications to the monograph process,” Burgess said. “The goal is to create a system that is more flexible and more efficient, and reflects the scientific innovations so that patients and consumers have greater access to better and safer OTC drug products.”
In August, President Donald Trump signed into law the Food and Drug Administration Reauthorization Act, which included the reauthorization of the Prescription Drug User Fee Act (PDUFA) through 2022.
“Following the success of PDUFA, Congress enacted additional user fee agreements (UFAs), such as those that cover medical devices, generic drugs, and biosimilar drug products, as well as animal drug products and generic animal drug products,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
“… New legislation is needed to allow FDA to establish a similar program for OTC monograph drug products that will help ensure a better resourced and more streamlined, efficient process,” Woodcock said.
U.S. Rep. Greg Walden (R-OR), the chairman of the House Energy and Commerce Committee, noted the FDA’s regulatory process has not been updated since the 1970s.
“As a result, there has been little to no innovation in this sector, and safety-related changes often take years to implement. That is simply unacceptable. Fortunately, FDA, regulated industry, and patient and consumer groups all agree that significant reform is necessary,” Walden said.