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House Begins Work on Over-the-Counter Drug Fees

FDA director: Consumers unprotected and manufacturers open to liability

(U.S. Air Force photo/ Airman 1st Class Scott Jackson)
(U.S. Air Force photo/ Airman 1st Class Scott Jackson)

The House began public deliberations Wednesday on a bill that would boost the Food and Drug Administration’s oversight of over-the-counter drugs in exchange for industry-paid fees.

A bipartisan draft bill released earlier this week has support from the FDA and the over-the-counter drug industry. Under the new proposal, drug manufacturers would pay an annual fee for their facilities and an extra fee each time they submit a request to review proposed changes related to their product.

Depending on the product, the FDA would take between 15 and 18 months to approve and finalize the proposed changes. It could also send out interim orders if there is an urgent safety need while it continues to discuss changes.

This would be a big shift from the current process, which has been unchanged since it was put in place in 1972. Rep. Michael C. Burgess, R-Texas, chair of the Energy and Commerce Health Subcommittee, which held Wednesday’s hearing, described it as “burdensome, multi-step rule-making process that can take years to resolve.”

There are currently around 30 employees with an $8 million budget who oversee the $32 billion over-the-counter drug industry. According to the FDA, that tiny staff has spent most of the last few years working on only three issues: new sunscreen ingredients, antibacterial hand soaps and pressing safety issues as they occur. The new funding would allow FDA to have around 100 employees working on the program within the next five years.

Drugs sold over the counter are not subject to a premarket approval, but instead must adhere to the standards laid out by the FDA in what’s known as a “monograph.” The monograph is a recipe of sorts: it lays out how much of a certain active ingredient is permitted in a drug for it to be sold without a prescription and what the drug’s label should say.

The FDA gets more deeply involved when a new monograph is proposed, or changes need to be made for an existing monograph. But creating or updating the monograph is different from the approval process for new drugs. Instead, the FDA must put the monograph through a three-phase rulemaking process. The FDA assigns a panel to review the active ingredients, then publishes a tentative monograph that is open for public comment, and then publishes the final regulation.

“All of this has led to a lack of innovation, an inability for timely updates to address safety issues, and much work left unfinished at the Food and Drug Administration,” Burgess said. Burgess is a cosponsor of the draft bill, along with Health Subcommittee ranking member Gene Green, D-Texas, Republican Reps. Bob Latta of Ohio and Brett Guthrie of Kentucky, and Democrats Diana DeGette of Colorado and Debbie Dingell of Michigan.

According to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, this process can drag on for years because as new scientific information is learned, it can require the FDA to reopen the administrative record and extend the public comment period.

“We have really been hampered in responding rapidly to safety problems,” she said. “And sometimes this leaves consumers unprotected. It may leave manufacturers open to liability.”

For instance, in 2013 when the FDA discovered serious skin reactions to acetaminophen, the active ingredient in Tylenol, the agency skipped the rulemaking process in favor of a voluntary request to manufacturers that they update their labels.

Woodcock said there are 88 monographs that are not finalized. The industry hopes that the money it sends FDA will result in a more certain regulatory framework for it to work in.

“Movement on unfinished items has ground to a halt,” said Scott Melville, president of the Consumer Healthcare Products Association, which led industry negotiations with FDA over the proposed fees.

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