| | | | |  | | By David Lim and Katherine Ellen Foley | With Megan R. Wilson
| | |  Today's the last day the public can comment on CMS' Medicare price negotiation program. | Getty Images | DEADLINE DAY — No, not taxes (file those by April 18). Public comments on CMS’ implementation plan for its Medicare Drug Price Negotiation Program are due today. “Our goal is to implement the law on time and in the most thoughtful way possible to be able to deliver to the people who rely on the program so that we improve access and affordability for drugs, and so then we reward innovation, where innovation is needed for those cures and therapies that people need,” CMS Deputy Administrator Meena Seshamani told POLITICO. In a letter sent Wednesday, a trio of Republican lawmakers hued closely to complaints the pharmaceutical industry is signaling it will file with the agency — CMS’ definition of “qualifying single-source drugs,” consideration of research and development costs, the prohibition of disclosure of information shared during negotiations, and limitations on judicial and administrative review. “If finalized as proposed, these provisions will serve to make bad policy worse, harming patients, caregivers, and health care providers across the United States for generations to come,” wrote Senate Finance Committee ranking member Mike Crapo (R-Idaho), House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and House Ways and Means Committee Chair Jason Smith (R-Mo.). Legal groundwork: CMS Deputy Administrator Meena Seshamani declined to comment on whether CMS anticipates litigation over the implementation of the first-ever Medicare drug-pricing negotiations and said that the agency is obligated to keep proprietary information disclosed during negotiations confidential. The agency is holding monthly technical calls on the implementation of the Inflation Reduction Act with health insurance plans and drug manufacturers and quarterly meetings with other stakeholder groups. It is also issuing information collection requests about the law’s provisions, such as its small biotech exemption. CMS spokesperson Patrice Martin said the agency will make comments submitted on the implementation plan “available on CMS.gov.” IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Condolences to those (read: us) who didn’t get any tickets to the opening slate of concerts at The Atlantis. Send tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ruth Reader talks with Megan R. Wilson, who reports on the simmering tensions at one of the nation’s leading trade organizations for generic drugmakers, which could threaten its lobbying clout at a crucial time for the industry.
| | | | | | | 
The FDA is requiring updated language with added warnings on opioid labels. | Toby Talbot/AP Photo | FDA UPDATES OPIOID SAFETY LABELS — On Thursday, the FDA said it will require immediate and extended-release opioid pain relievers to feature labeling information about the risks of addiction. Specifically, the labeling changes will indicate that pain treatment for outpatient surgeries generally requires taking pain pills for only a few days and that storing unused medication can heighten the risk of opioid misuse. The agency’s guidance also notes that extended-use pills should be used only for patients with persistent and severe pain. The updated labels will also warn against hyperalgesia, a condition in which taking opioids leads to increased pain or an increased perception of pain over time. If patients increase opioid use in response, they could risk overdosing. The new guidance is one part of the FDA’s efforts to reduce unneeded opioid prescriptions while providing the meds for patients who really need them as the nationwide opioid overdose epidemic continues to rage. EXPERTS DEBATE ANTIPSYCHOTIC FOR ALZHEIMER’S — The FDA’s independent expert advisers on neurologic and psychopharmacological drugs meet today to discuss whether they recommend the agency approve Rexulti, an antipsychotic from Lundbeck and Otsuka, to treat agitation in patients with Alzheimer’s disease. Rexulti was first approved in 2015 to treat schizophrenia and major depressive disorder, and no other therapies exist to treat agitation in Alzheimer’s. The companies showed in two Phase III clinical trials that the drug reduced agitation over three months, but a third trial failed to meet its primary endpoint.
| | | | GO INSIDE THE 2023 MILKEN INSTITUTE GLOBAL CONFERENCE: POLITICO is proud to partner with the Milken Institute to produce a special edition "Global Insider" newsletter featuring exclusive coverage, insider nuggets and unparalleled insights from the 2023 Global Conference, which will convene leaders in health, finance, politics, philanthropy and entertainment from April 30-May 3. This year’s theme, Advancing a Thriving World, will challenge and inspire attendees to lean into building an optimistic coalition capable of tackling the issues and inequities we collectively face. Don’t miss a thing — subscribe today for a front row seat. | | | | | | | | | APPEALS COURT LIMITS MIFEPRISTONE ACCESS — On Thursday, the Biden administration said it planned to file an emergency stay request with the Supreme Court regarding an appeals court ruling on abortion pill access. A three-judge panel of the 5th Circuit Court of Appeals agreed late Wednesday to temporarily block a federal judge’s ruling in Texas that suspended the FDA’s 2000 approval of mifepristone, POLITICO’s Kyle Cheney, Josh Gerstein and Alice Miranda Ollstein report. However, the judges temporarily allowed other portions of the Texas ruling to take effect, meaning the drug would be restricted to use for up to the first seven weeks of pregnancy instead of 10 and could not be distributed in retail pharmacies. The appeals court also upheld the ruling that the drug must be prescribed in person by a doctor.
| | | | CDC ADVISERS TO DISCUSS COVID BOOSTERS — The Advisory Committee on Immunization Practices plans to convene Wednesday to discuss Covid-19 boosters, the agency confirmed to Prescription Pulse. No formal agenda has been set yet, and its recommendations are not binding — but the committee’s meeting is a key step to formalizing the forthcoming booster schedule. In January, the FDA’s independent advisers recommended the agency update primary Covid vaccinations to be only bivalent shots targeting the BA.4/BA.5 strain. The agency hasn’t made those updates yet and said Thursday that it had nothing to share at this time.
| | HELP SEEKS HELP ON DRUG PRICING — The Senate HELP Committee is pushing back a planned markup on a bipartisan drug-pricing bill while it holds closed-door roundtables with academics, former FDA officials, industry executives and pharma attorneys, Megan reports.
| | DRAMA IN GENERICS LAND? Upheaval at the Association for Accessible Medicines has Washington buzzing about whether the trade group can advocate for biosimilar and generic manufacturers during a crucial legislative period for the industry, Megan reports. AAM broadly rejected the characterization that the group is struggling — even as interim CEO David Gaugh took part in a closed-door roundtable about generics with Senate HELP Committee members earlier this week. But the industry group is dealing with a discordant membership, a number of high-level personnel departures and significant budget cuts so far this year.
| | | | PROPOSED ETHYLENE OXIDE TIMELINE SLAMMED — The medical device industry is ringing alarm bells about whether it can comply with the EPA’s proposed 18-month timeline for new emissions standards for ethylene oxide, a carcinogenic gas used to sterilize billions of medical devices annually. “It could take many months for abatement equipment to arrive,” AdvaMed CEO Scott Whitaker said in a statement. “Supply chains and manufacturing are still recovering from the pandemic.” But the EPA said on Tuesday that the timeline for the proposed rule, which it plans to finalize in 2024, provides enough time for sterilizing facilities to comply with the new requirements, POLITICO’s Alex Guillén and David report. The proposed update to emissions rules for commercial sterilizers, along with directives issued via the EPA’s authority under federal pesticide law, will curb ethylene oxide emissions by 80 percent at 86 facilities around the country, according to the agency. PHILIPS’ WRIST SLAPPED AGAIN — The FDA said in a notice Thursday that the number of replacement and remediated Philips Respironics ventilators, bilevel positive-airway pressure machines and continuous positive-airway pressure machines subject to recall “is considerably less” than the nearly 2.5 million “replacement devices and repair kits” listed on the company’s website. “The 2,460,000 number includes manufactured repair kits that Philips shipped internally to their repair facilities, which are not replacement or remediated devices that have been shipped to consumers,” said the FDA notice. “We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device.” | | | Carol Cave will step in as acting FDA associate commissioner for regulatory affairs when Judith McMeekin retires on June 30, according to the advocacy group Alliance for a Stronger FDA.
| | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
Comments
Post a Comment