Following the passage in the US House of Representatives of a bill that would reauthorize user fees for prescription drugs, generic drugs, biosimilars, and medical devices, the White House issued a statement to reiterate its position to fund premarket reviews by the US Food and Drug Administration (FDA) 100% by user fees, which would result in more than a $1-billion increase in user fees over current levels.
The FDA Reauthorization Act of 2017 (H.R. 2430), which passed the House on July 12, 2017, reauthorizes the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments, the Biosimilar User Fee Act, and the Medical Device User Fee Amendments. 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 of 2017. User fees for prescription drugs, generic drugs, biosimilars, and medical devices are authorized every five years, and the current user-fee programs are scheduled to expire at the end of September 2017 and need Congressional authorization to continue. The companion legislation in the Senate is still under consideration.
A key difference between the Congressional bills and 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 appropriations for the FDA.
“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 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 Administration also expressed other concerns with the bill. “The Administration is also concerned with certain other provisions in the bill, such as those providing additional market exclusivity to manufacturers, which could make exclusivity unpredictable and decrease competition,” said the White House statement. “The Administration is committed to promoting the availability of generics in an efficient and effective manner that avoids unintended, adverse consequences. In addition, there are a number of important technical changes that the Administration seeks to make to the bill, including adjusting the foreign drug-facility inspection fee.”
Source: White House