By Lauren Gardner, Katherine Ellen Foley and David Lim

Presented by 340B Health

Ten prescription drugs will be subject to Medicare price negotiations under the Inflation Reduction Act. | Scott Olson/Getty Images

WHAT’S TO COME FOR DRUG PRICE TALKS — All the makers of the 10 drugs subject to the inaugural Medicare drug price negotiations have opted into the talks with CMS.

Amgen, J&J and Novartis confirmed their participation to POLITICO on Monday. Novo Nordisk made it official Sunday, days after filing its lawsuit challenging the program’s constitutionality.

Business as usual, for now: The next public step in CMS’ implementation of the watershed negotiations will focus on gathering patient input on the first drugs chosen — a key factor in how the agency will calculate the drugs’ prices. The listening sessions will launch Oct. 30 and run through Nov. 15, just as the Biden administration is ramping up talks with the affected companies, POLITICO’s Robert King writes.

A conservative judge Friday rejected the U.S. Chamber of Commerce’s attempt to halt negotiations while challenges to the program wind their way through the courts, finding that drug manufacturers don’t face “imminent and irreparable” harm, Lauren writes. That makes it unlikely any drugmakers will try their hands at a preliminary injunction request at this early stage in the program.

Up next on the legal docket: While Judge Michael J. Newman, a Trump appointee, also denied the DOJ’s motion to dismiss the Chamber case outright, he directed the group to amend its complaint to name which member companies of two of its state chamber co-plaintiffs would be affected by the talks.

Newman also asked the Chamber to clarify AbbVie’s role in making the cancer drug Imbruvica; the DOJ has argued that an AbbVie-owned subsidiary, Pharmacyclics, will be responsible for negotiating with CMS.

More dates to watch: The DOJ is due to submit its first responses to Bristol Myers Squibb’s and J&J’s combined cases by Oct. 16, to AstraZeneca’s suit by Nov. 1 and to Boehringer Ingelheim’s case by Dec. 6.

Merck is scheduled to reply to the DOJ’s opposition to its lawsuit by Oct. 19.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. How is the fall allergy season treating everyone as they try to dodge the myriad viruses out there? Your host is quite sneezy but promises it’s just nature!

Send news and tips to Lauren Gardner ([email protected] or @Gardner_LM), David Lim ([email protected] or @davidalim) and Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Kelly Hooper talks with POLITICO reporter Ben Leonard, who breaks down what will happen to health care agencies and programs now that a continuing resolution will keep the federal government open through Nov. 17.

A message from 340B Health:

340B bridges the gaps in access to specialized services, providing support and ensuring equitable access to life-saving treatments. 340B helps pay for care for patients with diabetes, cancer, HIV/AIDS, opioid dependency, and mental illness, as well as those needing emergency trauma or burn care. 340B drug discounts – not taxpayer dollars – pay for this comprehensive care. Protecting 340B is crucial for the health of patients and communities. Learn more.

FDA advisers are set to consider this week which flu strain should be recommended for next year's flu season in the southern hemisphere. | Tim Boyle/Getty Images

FDA ADVISERS TO CONSIDER FLU VACCINE — On Thursday, the FDA’s vaccine advisory committee will discuss Flu Vaccine strain selection for the southern hemisphere’s 2024 influenza season, which typically runs from April to September.

Last week, the WHO recommended a trivalent flu vaccine for the southern hemisphere for vaccines using both egg cultures and cell cultures that would protect against two A strains of the virus and one B strain of the virus.

Global health experts will convene again in February and March to discuss the flu vaccine for the northern hemisphere’s 2024-2025 season, which begins in October.

BIOSIMILAR FOR JUVENILE ARTHRITIS DRUG APPROVED — The FDA has approved Biogen and Bio-Thera's Tofidence, the first biosimilar for the monoclonal antibody Actemra from Genentech.

The antibody is used to treat moderate-to-severe rheumatoid arthritis in adults and certain types of juvenile arthritis in children 2 and older. It is the first time a biosimilar for systemic juvenile idiopathic arthritis has reached the market.

DOWNLOAD THE POLITICO APP: Stay in the know with the POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need. DOWNLOAD FOR iOS – DOWNLOAD FOR ANDROID.

GOP OPEN TO LDT LEGISLATION — Fresh off the release of the FDA’s long-awaited proposed rule to designate most laboratory-developed tests as medical devices subject to stricter review, top Republican lawmakers are signaling they are willing to again discuss a legislative solution.

House Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) — who last year led efforts to block the VALID Act from being attached to an end-of-the-year package — slammed the proposed rule as a costly regulation that would “stifle innovation.”

“Any LDT policy should go through the legislative process with deliberative consideration by the committees of jurisdiction,” McMorris Rodgers said. “In order to strike the appropriate balance between adequate protections of public health and facilitating innovation, the FDA should rescind this rule and allow Congress — the people’s voice — to consider the matter.”

Her Senate counterpart, HELP Committee ranking member Bill Cassidy (R-La.) also argued that the FDA overstepped.

“While past legislative efforts may have missed the mark, it is time for Congress to assert itself and clarify FDA’s authority in the regulation of diagnostic tests,” Cassidy said in a statement.

A message from 340B Health:

mRNA SCIENTISTS WIN NOBEL PRIZE — Two scientists credited with pioneering research on the messenger RNA technology that underpinned two of the most effective Covid-19 vaccines were awarded the Nobel Prize in medicine Monday.

Katalin Karikó and Drew Weissman’s research and discoveries in the 1990s and 2000s “eliminated critical obstacles on the way to clinical applications of mRNA,” the Nobel Assembly said.

WHO ENDORSES SECOND MALARIA SHOT — The World Health Organization recommended a new malaria vaccine Monday for children, a move that could lead to more widespread access to such shots in sub-Saharan Africa, POLITICO’s Carmen Paun reports.

The vaccine, developed by the University of Oxford, is expected to be cheaper and more plentiful than a competitor made by GlaxoSmithKline. No head-to-head trials have been conducted to compare the shots’ performance, but public health officials expect the availability of two options will help combat malaria across the continent once they’re broadly rolled out.

Neal Fowler, CEO of Pathalys Pharma, and Don DeGolyer, former founder and director of Vertice Pharma, began their tenures as members of Emergent BioSolutions’ board of directors on Oct. 1.

A NEW POLITICO PODCAST: POLITICO Tech is an authoritative insider briefing on the politics and policy of technology. From crypto and the metaverse to cybersecurity and AI, we explore the who, what and how of policy shaping future industries. We’re kicking off with a series exploring darknet marketplaces, the virtual platforms that enable actors from all corners of the online world to traffic illicit goods. As malware and cybercrime attacks become increasingly frequent, regulators and law enforcement agencies work different angles to shut these platforms down, but new, often more unassailable marketplaces pop up. SUBSCRIBE AND START LISTENING TODAY.

Funding for research on smell loss lags even after the pandemic led to increased interest in olfactory disruption, Hannah Docter-Loeb writes for Undark.

Biosimilars have lowered costs for Medicare Part B beneficiaries but could be more widely used, a recent HHS Office of Inspector General report found.

Genomic Health agreed to a $32.5 million settlement Monday with the DOJ over allegations it made false claims to Medicare with its cancer diagnostic tests.

The FDA published final guidance Monday labeling therapeutics whose doses are dependent on patients’ weight or the size of the targeted surface area.

A message from 340B Health:

340B hospitals are an essential part of the nation’s health care safety net, providing crucial services to patients with low incomes and those who live in rural America. Hospitals use 340B savings – not taxpayer dollars – to provide most of the nation’s unpaid and Medicaid hospital care, and they deliver vital services where access is limited. They help keep rural hospitals open for the patients and communities they serve. 340B lowers health care costs; supports doctors, nurses, and pharmacists; and expands care for patients – all without using any taxpayer dollars. Protecting 340B is the best way forward for patients and communities. Learn more.

Follow us on Twitter

Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings

This email was sent to [email protected] by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA

Please click here and follow the steps to unsubscribe.