A major leader of a Senate medical innovation package is opposed to giving the Food and Drug Administration any new mandatory funding.
The Senate Health, Education, Labor and Pensions Committee advanced the last of 19 medical innovation bills to the Senate floor during a hearing Wednesday. Senators also are negotiating over how to provide the National Institutes of Health a one-time mandatory funding boost.
But HELP Chairman Sen. Lamar Alexander, R-Tenn., slammed the door on a similar boost for the FDA.
“Sen. Alexander said that he believes the case can be made for one-time support for limited mandatory funding at the NIH for high-priority initiatives, which have a beginning and end,” an Alexander aide told the Washington Examiner. “There is no similar justification for mandatory funding at the FDA, which is funded through both appropriations and industry user fees.”
Mandatory funding must be maintained every year, while discretionary funding levels can be changed. Democrats have been pushing for mandatory investments in both the NIH and the FDA, but Republicans have been more reluctant to mandatory increases.
The House version of the legislation, the 21st Century Cures Act, included $550 million in new mandatory funding for the FDA over five years. The money was added after Democrats said the agency needs funding to implement new regulatory tools and pathways included in the package to speed up drug and device approvals.
Advocates for the FDA have been emphasizing the need for new funding.
Without new money, the agency will be saddled with meeting new requirements with the same resources, said Steven Grossman, executive director of the Alliance for a Stronger FDA, which pushes for more funding for the agency.
Both the House and Senate measures include new mechanisms to approve breakthrough medical devices much faster than normal devices and streamline approval of antibiotics to combat superbugs.
It also aims to streamline and modernize clinical trial regulations to remove barriers to conducting trials that can lead to new treatments. Other bills would reduce paperwork requirements for NIH scientists and help the FDA and NIH attract top talent.
Meanwhile, Alexander and Democrats on the Senate HELP committee remain in negotiations over the “NIH Innovation Fund.”
Alexander said during the hearing Wednesday the fund would be a one-time boost used only for certain projects such as Vice President Joe Biden’s cancer moonshot. The fund would go to the Senate floor about the same time as the 19 innovation bills, Alexander said.
Some Democrats signaled at the hearing that funding for NIH is important and will determine whether they support the entire innovation package.
“There is no deal yet. I do not support other innovation legislation until we have one,” said Sen. Elizabeth Warren, D-Mass., during the hearing.
Sen. Patty Murray, D-Wash., said during the hearing that “stronger mandatory investments” in both NIH and the FDA are needed. “I’m glad Chairman Alexander has expressed willingness to work with us on these priorities,” she said.
Alexander said during the hearing it is not clear when the innovation package will hit the Senate floor but he received assurances from Majority Leader Mitch McConnell that it will.
