User fees for prescription drugs, generic drugs and biosimilars are reauthorized.
On August 3, 2017, the US Senate voted to pass The FDA Reauthorization Act, which was previously passed by the US House of Representatives in July 2017. The bill reauthorizes user fees for prescription drugs, generic drugs, and biosimilars for a five-year period beginning on October 1, 2017, if signed into law.
Notably, the bill received bipartisan support from the time a discussion draft was first proposed in April 2017 by members of both the House and Senate. It does, however, differ from the budget proposed by the Trump Administration in May 2017 that called for the use of user fees of greater than $1 billion to replace federal funding of FDA’s premarket review process.
In July, the Trump Administration was still pushing for higher user fees. The White House issued a statement on July 12, 2017: “To better support FDA's life-saving mission while carefully spending taxpayer dollars, the President's Budget asks companies that benefit directly from FDA's premarket review of medical products to finance 100 percent of FDA's premarket review. In its current form, H.R. 2430 [The FDA Reauthorization Act] would require significant investment of taxpayer resources in FDA's medical product review programs. The Administration urges the Congress to provide for 100 percent user-fee funding within the reauthorized programs. In an era of renewed fiscal restraint, industries that benefit directly from FDA's work should pay for it."
The Senate bill does amend fees for brand name drugs but eliminates them for supplemental new drug applications and drug-manufacturing facilities. The prescription drug-product fee is also replaced with the prescription-drug program fee, which is assessed on new drug application holders for each drug they have approved, up to five drugs. In addition, 80% of revenues must be generated by these prescription-drug program fees, with the rest obtained through application fees. As a result, the total revenue from user-fees is adjusted annually to reflect the need for reviews. There are no user fees for supplements to generic-drug applications. Holders of approved generic-drug applications pay an annual fee tied to the number of applications they hold.
Separately, FDA issues draft goals and procedures for a proposed user-fee program for over-the-counter drugs designed to provide funds to the agency for the evaluation of ingredients in or proposed to be in OTC monographs.