| | | | |  | | By David Lim and Lauren Gardner | With help from Carmen Paun
| | |  Rep. Diana DeGette expressed disappointment over the FDA’s new rule deeming laboratory-developed tests as medical devices. | Francis Chung/POLITICO | TESTING, TESTING — An hour after the Federal Register typically publishes at 8:45 a.m. on Monday, a flurry of government regulations posted, including a long-awaited rule from the FDA that regulates laboratory-developed tests as medical devices. The new requirements, which kick in over the next four years, include a handful of substantial changes from the agency’s initial proposal. Chief among them is a grandfathering clause which means the FDA will “generally not enforce” premarket review and quality systems requirements for currently marketed tests. Still, industry groups and lawmakers rushed to slam the FDA regulation as an overreach. The American Clinical Laboratory Association’s president, Susan Van Meter, said her trade group — which represents Quest Diagnostics and Labcorp — has “grave concerns about this rule as a matter of both policy and law.” Sen. Bill Cassidy (R-La.), ranking member of the Senate HELP Committee, said the agency “does not have the authority to unilaterally increase its regulatory jurisdiction.” And Rep. Cathy McMorris Rodgers (R-Wash.), who chairs the House Energy and Commerce Committee, urged the FDA to abandon the rule because it “lacks the clear statutory authority to implement it.” Legislation on the horizon? Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) — co-sponsors of legislation known as the VALID Act — said that while they are disappointed with the rule, they “recognize that FDA’s action today is because Congress hasn’t acted yet.” Jeff Shuren, the FDA’s top medical device regulator, told reporters the agency is still open to working with lawmakers to pass a legislative overhaul of testing regulation that could supersede the final rule. But it is unclear what the path forward is for legislative action; the November election means any controversial bills will likely wait until the lame-duck period for consideration. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Do you know why the Federal Register was delayed on Monday? We want to hear from you! Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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PhRMA’s challenge to Medicare price negotiations for drugs like those above will be heard in the 5th Circuit Court of Appeals on Wednesday. | Scott Olson/Getty Images | PhRMA’S DAY IN COURT — The branded drug lobby’s bid to stop the Biden administration’s Medicare drug price negotiation program will continue Wednesday at what’s regarded as the country’s most conservative appellate court. PhRMA’s appeal to the 5th Circuit will be heard by a three-judge panel consisting of one appointee of President Joe Biden and two conservative jurists — one of whom, Judge Jennifer Walker Elrod, wrote the 2023 opinion rolling back abortion pill access that was recently argued before the Supreme Court. A lower court ruled in February that the lawsuit, led by an infusion provider association based in Texas, was filed in the wrong venue. The groups maintain that the program is unconstitutional because it violates pharma companies’ due process rights and unduly imposes excessive fines on them should they decline participation. Left-leaning legal experts have panned PhRMA’s lawsuit as the weakest of the nine challenges to the program. But the industry’s play for the conservative appeals court suggests its end goal is getting the Supreme Court to consider their arguments against one of the Biden administration’s signature achievements. Another Biden win: Meanwhile, Bristol Myers Squibb’s and Janssen’s challenges to the program were rejected Monday by New Jersey District Court Judge Zahid Quraishi, Lauren reports, handing the administration another legal victory on the negotiations. A J&J spokesperson told POLITICO the company would appeal the decision. “The IRA’s price control provisions will constrain development of new medicines, limit patient access and choice and negatively impact overall quality of care,” the spokesperson said.
| | | | AD COMM SPOTLIGHT — The FDA will hold an all-day listening session on June 13 as part of an agency effort to rethink how it uses advisory committees — the independent expert panels that make nonbinding but closely watched recommendations on a slew of regulatory issues. “Gathering broad feedback on the advisory committee process and how these committees inform agency decisions in an open and transparent platform will inform our work to further enhance how the FDA uses the input of our external experts,” FDA Principal Deputy Commissioner Namandjé Bumpus said in a statement. The focus: The agency is considering several issues as it takes public comment, which includes an Aug. 13 deadline for written input — incorporating diverse viewpoints within committee rosters, simplifying the administrative burden that panel service imposes on members and improving communication around the panels’ missions. On the last point, the FDA indicated in its announcement that it wants to clarify for the public how adcomms’ advice is used in the regulatory decision-making process — namely that it’s one piece considered among several other factors. Bumpus has made revamping adcomms one of her priorities since joining the FDA as chief scientist in 2022. MENTHOL ON THE BACKBURNER — Public health groups and prominent lawmakers are slamming President Joe Biden for Friday’s announcement to delay an FDA rule to ban menthol cigarettes — a step they say will hurt his campaign to end cancer. “The White House fell for industry rhetoric, and as a result, public health will suffer,” said Karen Knudsen, CEO of the American Cancer Society and the American Cancer Society Cancer Action Network. The decision to delay the ban rather than abandon it means the White House could revive the rule if Biden wins reelection in November, said three people familiar with the matter, who were granted anonymity to discuss internal deliberations. But there’s little expectation it will be released during Biden’s first term, as health officials inside the administration, including FDA Commissioner Robert Califf, had planned. “It’s a shame that an administration committed to ending cancer as we know it has retreated from this critical public health strategy,” Senate Majority Whip Dick Durbin (D-Ill.) said. “I urge them to revisit this unacceptable delay and to do what is right to prevent needless cancer deaths.”
| | | | POLITICO IS BACK AT THE 2024 MILKEN GLOBAL CONFERENCE: POLITICO will again be your eyes and ears at the 27th Annual Milken Institute Global Conference in Los Angeles from May 5-8 with exclusive, daily, reporting in our Global Playbook newsletter. Suzanne Lynch will be on the ground covering the biggest moments, behind-the-scenes buzz and on-stage insights from global leaders in health, finance, tech, philanthropy and beyond. Get a front-row seat to where the most interesting minds and top global leaders confront the world’s most pressing and complex challenges — subscribe today. | | | | | | | | DRUG SAFETY IN FOCUS — The Senate Armed Services Subcommittee on Personnel will hold a hearing today on the Pentagon’s “efforts to ensure servicemembers’ access to safe, high-quality pharmaceuticals.” Senior Defense Department officials, including the assistant secretary for health affairs and the Defense Logistics Agency’s director of acquisition, will testify.
| | | | FTC FINES MASK COMPANY — A company behind a face mask marketed during the Covid-19 pandemic as supposedly “N95-grade” must pay more than $1.1 million in refunds to customers plus a civil penalty, the Federal Trade Commission said Monday in a proposed settlement. The agency said the company, Razer Inc., advertised its Zephyr masks as equivalent to N95 respirators without seeking federal certification.
| | | | CHIKUNGUNYA VACCINE SUBMISSION — Danish vaccine maker Bavarian Nordic has started submitting data to the FDA for approval of its chikungunya vaccine, aiming to complete the submission by the end of June, the company said Monday. The FDA approved the first vaccine against chikungunya in November, but it’s only licensed for adults. Bavarian Nordic’s candidate vaccine is geared toward people 12 and older. Why it matters: The chikungunya virus is mainly transmitted by mosquito bites and is considered an emerging global health threat, with at least 5 million cases reported globally over 15 years. The highest infection risk is in tropical and subtropical regions of Africa, Southeast Asia and parts of the Americas, according to the FDA. But the virus has been spreading to new areas, causing a rise in case numbers.
| | | | Philips Respironics reached a $1.1 billion settlement with CPAP users who contended they were harmed by the company’s sleeping devices, The New York Times’ Christina Jewett reports. Philips did not admit to any fault.
| | | Michael Rogers, associate commissioner for regulatory affairs of the FDA’s Office of Regulatory Affairs, is slated to speak to the Alliance for a Stronger FDA on Wednesday at 12:30 p.m. EDT. | | | | Follow us on Twitter | | | | Follow us | | | | |
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