US Senator Richard Burr tables new FDA User Fee Programs citing “devastating” impact of FDASLA Act
15 Jul 2022 --- Amid growing concerns the US Food and Drug Administration Safety and Landmark Advancements (FDASLA) bill may not pass through US Senate, Republican Senator Richard Burr is introducing the FDA Simple Reauthorization Act.
The Act would reauthorize the FDA’s prescription drug, generic drug, biosimilar, and medical device user fee agreements and scraps provisions related to the supplement industry.
Debates over the FDASLA Act have been ongoing for months, with industry opposing the bill that aims to grant the FDA more control over cosmetic and dietary supplements.
“The legislation I’ve introduced preserves the user fee agreements as they’ve already been negotiated – without harmful additions,” says Burr.
“It keeps FDA’s critical operations running, protects existing scientific experts and ongoing hiring activities at the agency, and ensures the agency can continue to review new medical products, while encouraging private sector investment in the next generation of developments.”
The provisions attached to the FDASLA are make it difficult for the HELP Committee to reach a consensus.
A troubled history
The Senate Committee on Health, Education, Labor and Pensions (HELP) has been trying to draft a user fee package that addresses “some of the most difficult issues facing the FDA, but also strengthens agency accountability for commitments made to innovators and patients”.
Nonetheless, Burr slammed Democrats for the partisan reconciliation package they put forward, which includes “devastating” drug pricing proposals. The proposals would also impact supplements, he flags.
He argues that the user fee package in its existing format “undermines the very purpose of the user fee program”.
Industry has branded the FDASLA Act as “dangerous” and “unwise” condemning its provisions.
Businesses in the supplement industry have requested the Committee remove the whole dietary supplement part of the FDASLA or include measures prohibiting the FDA from excluding or removing products from the listing unless and until the product is subject to final agency action.
Unnecessary provisions?
The Natural Products Association (NPA), a staunch opponent of the FDASLA, responded favorably to Burr’s proposal.
“Senator Burr is right that extraneous, unnecessary and costly dietary supplement provisions have no place in this legislation and should be applauded for this principled stance. The dietary supplement provisions in the FDASLA would drive up the cost for consumers while preventing them from accessing certain products,” supports NPA’s president and CEO, Daniel Fabricant.
“As the nation faces record double-digit inflation, Congress should not be making it more expensive for people in the US to stay healthy. Additionally, Congress has never required the nutritional supplement industry to pay user fees, and supplements are not prescription drugs, generic drugs, medical devices, or biosimilars, so including dietary supplement provisions was not only controversial but unprecedented.”
The FDA is under pressure to have the user free programs authorized by September. Without this approval, the agency may have to lay off personnel in its medical product review department whose job positions are funded through the user fees.
Businesses within the space have long called for an FDA overhaul, arguing the agency is unable to regulate the industry and failing to carry out inspections where needed.
By Andria Kades
