This legislation allows the Food & Drug Administration (FDA) authority to continue to access biopharmaceutical manufacturer user fees, which will be paid to the FDA for fiscal years (FY) 2018 through 2022. The fees fund a significant portion of the FDA’s review budget and must be reauthorized by Congress every five years.

Additionally, H.R. 2430’s other provisions could have a major impact on stakeholders moving forward, especially when paired with the FDA’s priorities under Commissioner Gottlieb. For example, the bill is intended to increase generic competition by expediting approvals, particularly for generics with little or no competition. The FDA’s commitment letter for activities funded by the bill additionally:

• Puts in place a continued focus at FDA on speedy approvals of products that treat an unmet need, patient-focused drug development, and incorporating new types of data into the approval process
• Contains clearer policies on the use of real-world evidence to support submissions and approvals, among many other topic areas

“The user fee programs are vital to the FDA’s ability to get drugs reviewed, approved, and to market in a timely manner,” said Jay Jackson, senior manager at Avalere Health. “Without these funds, we would expect review times to slow down significantly, as well as a drastic reduction in new policies that are intended to modernize the FDA regulatory process.”