HOUSE E&C HEALTH PANEL ADVANCES USER FEE PACKAGE — The House Energy and Commerce Health Subcommittee advanced legislation Wednesday that would establish an Advanced Research Projects Agency for Health and reauthorize Food and Drug Administration medical product user fee programs, as well as certain mental health and substance use disorder programs. One of the more contentious debates of the subcommittee markup centered on regulation of third-party servicers of medical devices, demonstrating the lack of appetite by committee leadership to open the user fee package to any amendments that lack broad consensus. The policy battle, which does not split down party lines, is whether Congress should define what constitutes remanufacturing of medical devices — potentially narrowing which firms can repair medical devices. “I just don't think that the policy on remanufacturing has reached a level of consensus, and it’s not going to reach a level of consensus by next week,” E&C Chair Frank Pallone (D-N.J.) said. “So if we tried to define remanufacturing, we would probably delay this bill weeks, if not months.” Health Subcommittee Chair Anna Eshoo (D-Calif.) disagreed, arguing that members could work with FDA on potential legislative language in the next week to address the issue. Eshoo also took issue with a bill provision that would effectively overturn a court decision decided against FDA in April 2021. She told POLITICO she wasn’t given a heads-up that the language — which would stipulate that contrast agents, radioactive drugs and over-the-counter monograph drugs should be regulated as drugs — would be included in the draft bill text. A potential “unintended consequence” of the provision, she said, is that it would treat eye-dropper medications as both devices and drugs for purposes of FDA regulation. “I think you pay a price when you don’t have hearings to develop a foundation and understanding of what an issue is,” Eshoo said after the markup. “I’m not happy about it, that language. It needs to be addressed.” Lawmakers, including Pallone, told POLITICO the full committee could mark up the bill as soon as next week. Eshoo indicated she’s optimistic more issues will be resolved before the next markup. “I don’t anticipate big fights,” she said. SENATE UFA BILL STILL TBD — The Senate HELP Committee’s top Democrat and Republican told Lauren Thursday that work was continuing on their user fee package. The chamber is in session for two more weeks before recessing for Memorial Day. “We’re working on the final parts of it now,” Chair Patty Murray (D-Wash.) said. “Hopefully fairly soon.” Ranking Republican Richard Burr of North Carolina said there haven’t been early discussions yet with House lawmakers on user fees to iron out any issues pre-conference. Whither baby formula: Your morning hosts understand the user fee reauthorization process doesn’t encompass the food side of FDA. But given its must-pass nature, Lauren wondered whether lawmakers might wade into legislating on the baby-formula shortage issue given its connection to FDA oversight of manufacturing facilities. Murray said she didn’t know yet, while Burr questioned what specifically Congress should legislate on the issue. “The plant has petitioned the FDA to reopen. They’re waiting on the FDA to sign off on that. If anybody else wanted to get into it, they’d still have to go through an FDA process that would be good manufacturing assessments, facility assessments,” Burr told Lauren. “The fastest way is for the FDA to act on the request to open the Michigan facility.” UPTON UPDATES ON CURES 2.0 — Rep. Fred Upton (R-Mich.) told Lauren on Wednesday that “there’s been a little conversation” between House and Senate members on how to advance CURES 2.0, his legacy legislation with Colorado Democrat Diana DeGette, pieces of which have been grafted onto the user fees package. “Their vehicle is going to be probably [Richard] Burr and Patty Murray’s bill on the pandemic,” he said. “So we’re looking ultimately to fold these together, is what I’d like to do. Those discussions have started.” A spokesperson for Murray didn’t respond to a request for comment. Upton said he and DeGette are receiving technical assistance for their bill from the Biden administration “and it wasn't quite ready for markup” on Wednesday. “We won’t be ready by full committee next week, but in the next couple of weeks, we’ll have … a new version that’s reflective of the changes that took place today and over the next week, and I’m encouraged that we’ll ultimately get a product by the end of the session,” he said.
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