October 5, 2022
The U.S. Congress has passed legislation that reestablishes the FDA user fee programs for medical devices and pharmaceuticals as part of a continuing resolution for the federal fiscal year 2023 budget. However, the final legislation omitted several provisions that were considered key provisions, such as language that would have granted the FDA its long-sought authority to regulate lab-developed tests (LDTs).
H.R. 6833 passed the House by a 230-201 vote held Sept. 30, 2022, the last day of the fiscal year, a reflection of both the expiring fiscal year and the end of the fourth medical device user fee agreement, MDUFA IV. The new user fee agreement ends Sept. 30, 2027, but the broad budgetary provisions of H.R. 6833 run only through Dec. 16, 2022, and include no new appropriations for the FDA’s Center for Devices and Radiological Health above fiscal 2022 levels.
Congress is not expected to convene again until after the mid-term elections to reconsider federal spending bills for the FDA and other parts of government, along with some of the programs and legislation that were left out of the final version of H.R. 6833. One of the most critical of these omissions is the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, the legislation that would authorize the FDA to regulate LDTs. However, H.R. 6833 did reauthorize FDA third-party inspections of device manufacturing facilities through mid-December.
Both the House and the Senate had passed their own versions of legislation for the FDA user fee programs earlier this year, with the Senate version carrying the VALID Act while the House version did not. The House version would have required that manufacturers of drugs and devices develop clinical trial enrollment diversity plans, and would have required the FDA to report to Congress annually on the progress in expanding clinical trial enrollment diversity. Both bills featured provisions that would have modified the FDA’s accelerated drug approval programs, including a requirement that post-approval studies be underway already when the agency approves the pharmaceutical.
The final vote in the House was preceded by a 75-25 Senate vote to approve H.R. 6833, and two members of the Senate Health, Education, Labor and Pensions (HELP) Committee released a statement promising to reexamine the omitted legislative proposals. Sen. Patty Murray (D-Wash.) and Sen. Richard Burr (R-N.C.), both of the HELP Committee, said H.R. 6833 “will ensure that FDA can continue its important work and will not need to send out pink slips” to agency employees.
Murray and Burr stated, “there is more work ahead this Congress to deliver the kinds of reforms families need to see from FDA, from industry, and from our mental health and pandemic preparedness efforts.” However, the legislative reforms that were left out may be difficult to pass in future legislation if those provisions are not acted upon in the upcoming lame duck session.
Scott Whitaker, President and CEO of the Advanced Medical Technology Association (AdvaMed) said in a Sept. 30 statement that passage of the legislation “sets the stage for a new era of innovation in health care, ensuring greater predictability, consistency, accountability, and communication between FDA and the medtech innovators who are changing the way patients seek and receive life-saving care.” He stated further, “we are in a golden age of medical technology innovation, and the improvements made by MDUFA V will serve as a catalyst for even greater health care transformations.”
Whitaker thanked Burr and Murray along with Reps. Frank Pallone (D-N.J.) and Cathy McMorris Rodgers (R-Wash.) for “their bipartisan leadership and important work over the course of this negotiation. We look forward to continuing to work with Congressional leaders and FDA officials to ensure the most effective treatments and diagnostics are available to the patients who need them most,” he concluded.
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