US Senate Passes User-Fee Reauthorization Bill

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-10-2017 14:16


The US Senate voted to pass The FDA Reauthorization Act, which reauthorizes user fees for prescription drugs, generic drugs, and biosimilars. The Senate voted on August 3, 2017 to pass the bill which follows the July 2017 passage of the bill from the US House of Representatives. The bill reauthorizes user-fee programs for the five-year period beginning October 1, 2017. The bill now goes to President Trump for consideration for signing the bill into law.

The bill is a product of a bipartisan Congressional effort, begun, in mid-April 2017, when members of the US House and Representatives and the US Senate proposed a discussion draft of The FDA Reauthorization Act.

A key difference between the Congressional bills and a budget proposal by the Trump Administration is the level of user fees. The President’s budget, released in May 2017, calls for more than $1 billion in new user fees to replace budget appropriations for the FDA. 

At the time of the passage of the House bill in July 2017, the Trump Administration re-iterated its position to increase the level of user fees to fund FDA’s premarket review process. “To better support FDA's lifesaving 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,” said the White House in a July 12, 2017 statement. “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.”

For prescription drugs, the Senate-passed bill, the bill amends user fees for brand name drugs. User fees are eliminated for supplemental new drug applications and drug manufacturing facilities. A prescription drug program fee replaces the prescription drug product fee. This annual fee is assessed on a new drug application holder for each approved drug for up to five drugs. The total user-fee revenue amount is adjusted annually for changes in review-process capacity needs and provides for operational reserves and additional direct costs. With respect to prescription drug user fees, the bill specifies that 80% of revenues must be generated by prescription drug program fees with the remainder from application fees.

Similarly, user fees are eliminated for supplements to generic drug applications. An annual generic drug applicant program fee is assessed on holders of approved generic drug applications. The amount of the fee is based on the number of applications held. Of total user-fee revenue, 35% must be generated from this fee.

Source: US Senate


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