By David Lim and Lauren Gardner

ROGRAMMING NOTE: Prescription Pulse won’t publish from Monday, Aug. 28, through Tuesday, Sept. 5. We’ll be back in your inbox on Wednesday, Sept. 6.

With help from Chelsea Cirruzzo 

President Joe Biden is expected to tout his efforts toward lowering Medicare’s Drug prices, which could save the program billions of dollars. | Patrick Semansky/AP Photo

MEDICARE NEGOTIATIONS’ DAY IN THE SUN — The last week of August is typically a sleepy affair in Washington. But next Tuesday will likely be an aberration: The Biden administration is expected to unveil the first 10 prescription drugs selected for Medicare price negotiations. The release is anticipated before stock trading begins that day.

The announcement kicks off the first direct negotiations between drugmakers and Medicare over a set of medicines — part of a decadeslong effort by Democrats to empower the government to take a role in the prices companies charge.

What drugs are the finalists? While the Biden administration is keeping a close hold on that potentially market-moving information, plenty of analysts have taken a crack at identifying which drugs might be on the inaugural negotiation list based on the most recent Medicare spending numbers.

The five drugmakers that have already sued the government over whether the negotiations program is unconstitutional also have tipped their hand on which products they expect to land on the list.

Analysts with expertise in Medicare drug spending say the list will likely include the blood thinners Xarelto and Eliquis made by Johnson & Johnson and Bristol Myers Squibb, respectively; diabetes drugs Januvia and Jardiance made by Merck and Eli Lilly/Boehringer Ingelheim, respectively; and the cancer drug Xtandi produced by Pfizer/Astellas.

The White House will hold a 2 p.m. gathering Tuesday on “lowering health care costs,” when President Joe Biden and other administration officials are expected to tout Medicare’s involvement in drug negotiations, which is expected to save the program billions of dollars and lead to lower prices for consumers.

Biden seeks to sell health policies like the new Medicare negotiations program as part of a broader “Bidenomics” agenda set to underpin his reelection campaign.

The drug pricing push, he argues, will help counter inflation and boost the economy by slashing the amount Americans shell out each year for critical medicines, although prices negotiated on the first set of drugs won’t take effect until 2026 per the Inflation Reduction Act enacted last year.

IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. We note the FDA’s affinity for “kids” (goats) and its support efforts to crush the advancement of invasive plants at its headquarters in White Oak, Md.

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 Carmen Paun talks with POLITICO White House correspondent Adam Cancryn about his exclusive reporting on the White House’s plan to unveil the first 10 drugs selected for Medicare price negotiations next week and the subsequent legal and political fights over health care costs that can be expected.

A CDC vaccine advisory committee will meet next month to make recommendations for updated Covid vaccines. | Ted Jackson/AP Photo

COVID SHOT UPDATE — The CDC’s vaccine advisory committee will meet on Sept. 12 to make recommendations for the next round of Covid-19 vaccines, the agency announced Thursday.

Vaccine makers Pfizer, Moderna and Novavax are updating their shots to target the XBB.1.5 Omicron subvariant, which, in recent months, the FDA selected because it was the dominant strain in the U.S. But since then, a new subvariant, EG.5, has become the dominant strain in the U.S., and a new viral lineage, BA.2.86, is drawing concern worldwide.

The CDC meeting is expected to follow FDA authorization of updated Covid shots. If the CDC endorses the FDA’s move, the fall rollout of the new shots could happen within days.

USPS RAPID TESTS COULD RETURN — Federal officials hint that free Covid-19 tests could again be mailed to the public as the administration gears up for a fall vaccination push, Chelsea reports.

“We maintain close ties with our partners over at the U.S. Postal Service,” an official told reporters. “Flipping back on COVIDtests.gov is a lever we still have available to us if we choose to do so.”

The U.S. Postal Service mailed a handful of free tests per household at the end of 2022, and a significant number of tests remain in the Strategic National Stockpile. The officials did not elaborate on whether decisions have been made about making free tests available again and when they would become available for order.

The administration has an ongoing program to deliver free tests when they’re ordered to long-term care facilities, health centers, schools, libraries and other locations.

Covid hospitalizations in the U.S. have ticked up in recent weeks, and the FDA hopes to get updated Covid shots to the public by mid-September.

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FIRST MS BIOSIMILAR APPROVED — The FDA approved on Thursday the first biosimilar to treat relapsing multiple sclerosis. The Sandoz biosimilar — called Tyruko — is a likely less expensive but just as effective injection treatment as the brand-name drug Tysabri. The new biosimilar is also indicated for certain patients who have moderate-to-severe Crohn’s disease.

CALIFF: LAB TEST LEGISLATION NEEDED — The FDA may be writing a rule regulating lab-developed tests, but Commissioner Robert Califf would prefer Congress weigh in on the issue of how to oversee the products.

“We’re going down the pathway of a rule. But my great hope is that Congress will pass legislation that is badly needed and will be a much better solution to the problem,” Califf said this week during an event hosted by the Alliance for a Stronger FDA, which advocates for agency appropriations.

More authority, please: That’s not the only thing on Califf’s congressional wishlist, Lauren reports. He also called on lawmakers to give the FDA greater authority to address drug shortages and money to regulate cosmetics, a new power the agency is beginning to implement.

BIOSIMILARS FORUM WANTS TO WEIGH IN — A trade group for biosimilar manufacturers has filed a friend of the court brief in support of the Pharmaceutical Research and Manufacturers of America’s lawsuit challenging the constitutionality of the Inflation Reduction Act’s Medicare drug price negotiations program.

The Biosimilars Forum argues that the program will have an adverse impact on the market for competition to expensive biological drugs.

“If CMS imposes no-floor price controls on a reference biological product, it will frequently be difficult, if not impossible, for a biosimilar to compete with that biological product on price and still be able to recoup its investment,” said the trade group’s brief. “Manufacturers thus may forgo making significant investments, and some may exit the biosimilars industry altogether.”

EUROPE GREEN-LIGHTS RSV VACCINE — The European Commission approved Pfizer’s respiratory syncytial virus vaccine on Thursday for infants via maternal immunization and older adults. The approval comes just days after the FDA signed off on the shot’s use in expectant mothers in the U.S. during a four-week period in the third trimester. The agency had approved the vaccine for older adults earlier this year.

Jim Jones will be the FDA’s first deputy commissioner for human foods, the agency announced this week. The EPA veteran will lead the troubled foods division after a series of food-safety breakdowns, including an infant formula plant shutdown that led to persistent nationwide shortages.

Alex Schriver is joining PhRMA’s public affairs team from advertising firm Targeted Victory, where he was head of public affairs, POLITICO Influence reports.

The Inflation Reduction Act has not yet disrupted pharmaceutical industry merger and acquisition activity on total spending in the space or the number of deals, Brookings Institution’s’ Richard Frank and Ro Huang write.

The FDA will hold a two-day virtual public meeting with the Reagan-Udall Foundation on Sept. 12-13 on clinical practice considerations for clinical trials.

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