The U.S. Senate Health, Education, Labor & Pensions Committee will evaluate the future of the fees the Food and Drug Administration levies on medical products during a hearing Tuesday.
The hearing comes not long after President Donald Trump released a 2018 budget blueprint doubling the $1 billion in revenue the fees generate, though the administration didn't specify what portion of that would come from medical devices versus pharmaceuticals, the latter historically generating a much larger source of fee revenue. The fees fund ways to expedite the FDA's product approval process and will be pivotal to Trump's promises to reform the agency.
The House Energy and Commerce health subcommittee hosted a hearing on expected changes to the FDA's Medical Device User Fee Admendments program last week. The Advanced Medical Technology Association, which represents devicemakers, is on board with the latest fee package, which CEO Scott Whitaker called a “win-win-win for the FDA, for innovation and most of all, for patients.”
“The reauthorization (of the changes) will allow the FDA to build upon the demonstrated success of this program, and in so doing, further benefit patients and affirm our nation's standing as a global leader in biomedical innovation,” said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in prepared testimony.
Vince Forlenza, outgoing AdvaMed chairman and CEO of Becton, Dickinson and Co., said the package is a boon for the device industry and BD, specifically. “We think it's the right bill, it has the right elements in there, and has the right financial structure,” he said.
Critics say an increase in fees could hurt smaller firms, including digital health startups with smaller budgets.
Trump's nominee to lead the FDA, Dr. Scott Gottlieb, will be responsible for using the fees to implement performance improvement programs at the agency.
As of Jan. 21, the FDA had 4,205 generic drug applications awaiting approval. Drugmakers and devicemakers alike have chastised the agency for having a large backlog of applications that stymies innovation. Trump has called the approval process “slow and burdensome” and has vowed to “slash restraints” on drug development.
