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The Senate Aug. 3 swiftly approved the FDA Reauthorization Act (FDARA) on a 94-1 vote. The president is expected to sign the bill, which previously passed the House and will enact the MDUFA IV user-fee agreement and make reforms tied to device accessory review, device facility inspections, and medical imaging FDA reviews.

 

 

 

 

 

 

 

The US Senate approved a bill to allow device and drug user fee programs to go forward over the next five years in a 94-1 vote on Aug. 3.

 

 

 

S. 2430 , the FDA Reauthorization Act (FDARA), matches a bill approved in the House last month. (Also see "US FDA User-Fee Bill Swiftly Passes US House, Now Moves To Senate" - Medtech Insight, 12 Jul, 2017.) Now it is up to the president who, despite reservations, is expected to sign the measure, which will provide the agency with about $1bn (pre-inflation) in user fees from medical device sponsors from FY 2018-FY2022, up by about $320m from fees authorized during the past five years. (Also see "User-Fee Facts: 10 Key Medtech Details From US FDA Agreements" - Medtech Insight, 11 May, 2017.)

 

 

 

FDARA, which includes the MDUFA IV user-fee agreement inked between the Obama-administration FDA and industry last summer in addition to a range of other device reforms (Also see "House Committee Advances User Fees With Full Slate Of Device Amendments" - Medtech Insight, 8 Jun, 2017.), was generally non-controversial among lawmakers. But its progress was nonetheless delayed to such an extent, due in part to the Senate's focus on repealing Obamacare, that FDA Commissioner Scott Gottlieb had to grant a reprieve on sending out 60-day advanced "reduction-in-force" notices to user-fee funded staffers. (Also see "Capitol Hill Update: Congress Gets Reprieve On User Fee Passage, While AdvaMed Weighs Device Tax Options" - Medtech Insight, 26 Jul, 2017.)

 

 

 

The Trump administration added some complications to the reauthorization process by requesting in its budget proposal a doubling of industry user fees to cover the full cost of pre-market drug and device reviews. (Also see "White House Continues To Push For Higher User Fees From Industry" - Medtech Insight, 14 Jul, 2017.)

 

 

 

FDARA was swiftly passed by senators shortly after the chamber separately approved S. 204, a "Right-To-Try" bill co-sponsored by Sens. Ron Johnson, R-Wis., and Joe Donnelly, D-Ind.

 

 

 

Sen. Johnson had threatened to hold up passage of the user fee bill unless S. 204 was attached to FDARA, or if Senate leadership would permit a separate vote on the right-to-try bill. (Also see "Senate Expected To Vote On US FDA User-Fee Bill August 3" - Medtech Insight, 2 Aug, 2017.) Formally known as the "Tricket Wendler Right to Try Act of 2017," S. 204 would permit unrestricted manufacturing, distribution and prescribing of experimental devices, drugs and biological products intended to treat a person with a terminal illness, when that is authorized by state law.

 

 

 

However, the medical product being used on the terminally-ill patient would have to have successfully completed first, a phase I or initial, small scale clinical trial, and remain under investigation

 

 

 

Alexander Cites FDARA's Device Reform Provisions

 

Senate Health, Education, Labor, and Pensions Committee Chair Lamar Alexander, R-Tenn., in addition to praising the passage of the four separate user fee agreements in the bill, also specifically pointed to provisions in FDARA that will enable device reforms.

 

 

Among these were provisions sponsored by Sens. Mike Enzi, R-Wyom., and Al Franken, D-Minn., to encourage medical device development for children; by Sens. Pat Roberts, R-Kansas, Donnelly, and Richard Burr, R-N.C. to allow more appropriate classification of accessories used with devices; and by Sens. Johnny Isakson, R-Ga., and Mike Bennet, D-Colo., to improve the medical device inspection process.

 

 

Passage of FDARA means that more than 5,000 FDA professionals – over one-fourth of the agency's staff – will be able to continue to bring innovative medical products to market, said Sen. Patty Murray, D-Wash.

 

 

Sen. Patty Murray, D-Wash., ranking member of the HELP panel, praised Sen. Robert Casey, D-Pa., and Franken's work to amend the bill while in committee to include post-market safety programs, and said she was relieved that because of FDARA's timely passage before a Sept. 30 deadline, "more than 5,000 FDA reviewers will be able to continue to bring innovative medical products to market."

 

 

Industry Points To Equipment Servicing, Imaging Contrast Provisions

 

Joe Robinson, chair of the Medical Imaging & Technology Alliance's board and senior VP of health systems solutions at Philips Healthcare, said the bill reflects "bipartisan efforts of the House and Senate to find reasonable, common-sense solutions to clear regulatory hurdles that hinder medical innovation."

 

 

The MITA chairman also applauded FDARA provisions that "provide contrast agent manufacturers with incentives to update contrast agent labels for products that have previously been approved," and the mandate in the bill for FDA to produce a report on quality and safety of devices that have been serviced by third-party organizations.

 

 

AdvaMed spoke directly about the improvements laid out in the MDUFA IV FDA/industry commitments. "The robust FDA performance goals, process improvements, increased accountability and additional resources provided for under the new user fee agreement represent a victory for the agency, innovation, and most importantly, patients," AdvaMed President and CEO Scott Whitaker said.

 

 

While industry reps praised the user fee bill, members of POGO, a "good government" reform group, said that FDARA will loosen medical device safety provisions.

 

 

Medical Device Manufacturers Association president and CEO Mark Leahey agreed, stating, "Patients and providers have always been the true beneficiaries of this program as it continues to seek improvements and efficiencies that ultimately result in better health care and outcomes."

 

 

Government Reform Group Says Congress Acted Too Fast

 

But not all groups were pleased with FDARA passage by the Senate. The Project on Government Oversight, a watchdog group that focuses on "good government" reforms, believes that "Congress should have hit the pause button instead of fast tracking FDA user fee legislation," according to POGO executive director Danielle Brian.

 

 

"The legislation contains troubling provisions that loosen oversight of medical device safety, and warrant scrutiny by Congress. More broadly, Congress should rethink a system that leaves the FDA so beholden to industry not just for funding, but for the terms of that funding," Brian added.

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