The House Energy and Commerce Committee on Wednesday unanimously advanced legislation that would speed up the development of new drugs and devices, sending the bill to the House.
The FDA Reauthorization Act reauthorizes a program in which the FDA collects user fees for each drug and device application and uses that money to hire more staff and speed up approvals. The program must be approved every five years, and the committee advanced the bill to the House by a 54-0 vote.
The user fee program needs to be renewed before the August recess, given that the program expires at the end of September. Otherwise, the agency could have to send layoff notices to more than 5,000 employees beginning in July.
The committee approved the addition of an amendment that would alter some of the language to allow hearing aids to be sold over the counter. It would ensure that they are sold only to adults and that they list symptoms so that people will discuss the option with their doctors.
Lawmakers also approved an amendment in which lawmakers agreed to discuss solutions to high prescription drug prices. Some members stressed at the beginning of the hearing that the legislation should have included specific provisions to tackle high drug prices.
Rep. Yvette Clarke, D-N.Y., said that accelerating the drug and device approval "means nothing if people don't have access to their medications," but said she would support the bill even though it did not make provisions for controls on drug prices.
Amendments about off-label prescribing were withdrawn.
User fees in fiscal 2016 accounted for 75 percent of the FDA's budget for generic reviews and 70 percent of the budget for brand-name drug reviews. The fees also made up 36 percent of the budget for medical devices and 29 percent for biosimilars.
The FDA will receive about $2 billion from all of the user fees in fiscal 2017, according to data from the Department of Health and Human Services.