The FDA may be freed up to put its user fees to use for product review for medical devices and drugs, if a bipartisan bill introduced in the House passes. In essence, the bill exempts the FDA user fees from sequestration and may take one burden off the already slow approval process.
That adds up to roughly $1 billion dollars paid in annual fees by device and pharma companies, according to Bloomberg.
The authors of the bill included Reps. Anna Eshoo (D-Calif.), Leonard Lance (R-N.J.), Doris Matsui (D-Calif.) and Mike Rogers (R-Mich.).
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Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
“It’s extremely troubling that the FDA’s industry-financed user fees are being sequestered. If the intent of sequestration is to limit public spending, withholding private monies is counterintuitive,” said Eshoo, a senior member on the Energy and Commerce Committee. “Whether one agrees or disagrees with sequestration, I don’t believe private dollars should be held hostage by the policy. It discourages investment in medical innovation and denies patients access to timely therapies.”
