House and Senate lawmakers are urging Congress to quickly re-up a program that speeds up drug and device approval times at the Food and Drug Administration.
House and Senate committee leaders introduced draft legislation to reauthorize the user fee program for the FDA, which needs to be renewed before the August recess. The reauthorization legislation comes at a time when the White House wants more of the agency funding to come from user fees and less from the federal government.
The draft released Friday would reauthorize the programs and doesn’t include any other FDA-related legislation.
During prior reauthorizations, lawmakers have generally added other FDA-related legislation. Some members have toyed with adding legislation on high drug prices in the latest reauthorization.
The FDA collects user fees for each drug and device application and uses that money to hire more staff and speed up approvals. But the program must be reauthorized every five years, with the current program expiring at the end of September.
However, lawmakers say that if the fee programs aren’t reauthorized by the start of the August recess, the agency could have to send layoff notices to more than 5,000 employees.
“The sooner we reauthorize the agreements, the better – to give patients, reviewers and companies certainty,” Sen. Lamar Alexander, R-Tenn., said Friday. Alexander heads the Senate Health, Education, Labor and Pensions Committee, which will work on the Senate version of the reauthorization.
The user fees have become a large part of the FDA’s budget since the program started more than a decade ago.
In fiscal 2016, user fees accounted for 70 percent of the budget for brand name drug reviews and 75 percent of the budget for generic reviews. In addition, user fees made up 36 percent for medical devices and 29 percent for biosimilars, which are similar to a tissue-based drug.
The program would allow the FDA to collect higher fees for drugs and devices. For instance, the total amount the FDA can take in brand name fees this year is $718.7 million. In fiscal 2018, that amount will increase to $878.6 million.
President Trump’s skinny budget released last month called for an increase in the fees to ensure that less federal spending goes to the FDA. The administration’s skinny budget would cut the funding for the Department of Health and Human Services, which includes the FDA, by $15 billion in 2018.
The administration said that it would recalibrate the user fees to more than $2 billion in 2018. The budget blueprint also said it would create some new regulations to speed up development of new products to compensate for the additional fees.
The FDA already receives about $2 billion from all of the user fees in fiscal 2017, according to HHS data.
It is not clear if the White House intends to renegotiate the user fee programs, which already have been negotiated for more than a year between the FDA and the industries.
