Tuesday, December 17, 2024

Health package waiting on the tarmac

Presented by PBM Accountability Project: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Dec 17, 2024 View in browser
 
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By Lauren Gardner and David Lim

Presented by PBM Accountability Project

Driving The Day

House Speaker Mike Johnson is seen in the U.S. Capitol Rotunda.

House Speaker Mike Johnson has promised to release details imminently about policy provisions attached to the end-of-year spending package. | Francis Chung/POLITICO

EVERY ENDPOINT FIXED — Everyone’s favorite health care soap opera — will they or won’t they cut a deal on some policy provisions for the year-end spending package — had yet to be canceled as of Monday evening, with House Speaker Mike Johnson promising imminent details that proved to be anything but.

The package is expected to contain several reforms opposed by pharmaceutical benefit managers, who say they would undermine the drug middlemen’s role as a counterweight to pharmaceutical companies.

That includes a push to delink the reimbursement the middlemen get from Medicare from the list price of drugs, a push to crack down on so-called “spread pricing” in Medicaid and the addition of transparency requirements for PBMs in the commercial market.

“Government mandates in the private market would completely eliminate employers’ choice in contracting decisions with PBMs as well as strip away the choice and flexibility they value in designing pharmacy benefits that best fit their patient populations,” the Pharmaceutical Care Management Association, which lobbies for PBMs’ interests, said in a statement.

Some conservatives like Rep. Chip Roy (R-Texas) — seen as likely to vote against the stopgap measure, anyway — have raised concerns about the PBM provisions. On Monday, Roy posted on X that “Pharma is dancing in the streets over” the PBM legislation.

“We should reduce the deficit and not pass stupid policies,” Roy said.

The PBM provisions in the package, reported on by POLITICO, are expected to save the federal government money, according to the Congressional Budget Office.

Joe Grogan, a former health official in the Office of Management and Budget during Trump’s first term, argued on X that Trump and his incoming administration “deserve a short term clean” continuing resolution.

“And now when the admin is about to come in and get this country moving again in the right direction they are going to be saddled with a bunch of exorbitant craziness that only a corruptocrat or an idiot would love,” Grogan posted on Friday.

What’s next: Text of the deal is expected to emerge imminently to comply with the House’s 72-hour rule for legislative text to be released before the chamber votes.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Is there anything happening in the pharma world before the end of the year that is flying under the radar? Let your hosts know before the mad holiday dash begins.

Send your tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

 

A message from PBM Accountability Project:

Pharmacy benefit managers (PBMs) are taking advantage of Medicare and America’s seniors. It's time for Congress to act. Rein in PBMs by requiring them to increase transparency, share discounts with seniors, and delink PBM profits from the cost of medicines in Medicare. Congress must pass S. 2973 and S. 3430 this year. Learn more.

 
In Congress

Robert F. Kennedy Jr. stands next to Capitol police.

Robert F. Kennedy Jr. met with GOP lawmakers on Capitol Hill on Monday and has more meetings scheduled for today. | Scott Applewhite/AP

THE RFK JR. HILL CAMPAIGNS — Robert F. Kennedy Jr. continues his Capitol Hill stump today, and his schedule includes meetings with the rising members of GOP leadership — such as incoming Senate Majority Leader John Thune — as well as Finance and Health Committee lawmakers.

Who’s not on the list? Outgoing Senate Minority Leader Mitch McConnell, a polio survivor, who issued a statement Friday slamming an effort to revoke FDA approval of the polio vaccine by one of Kennedy’s associates.

The oppo: Meanwhile, Kennedy detractors are buying tens of thousands of dollars in digital and billboard ads across the states of certain Republican senators in their bid to sink his nomination, POLITICO’s Daniel Payne writes. Those senators include Lisa Murkowski (R-Alaska), Mike Crapo (R-Idaho), Susan Collins (R-Maine), Bill Cassidy (R-La.), Thom Tillis (R-N.C.), Mike Rounds (R-S.D.), John Cornyn (R-Texas), Shelley Moore Capito (R-W.Va.) and the newly elected Jim Justice (R-W.Va.).

Thought bubble: Your morning host has also wondered about Justice, who was famously bullish on vaccines during the Covid pandemic as governor and organized a task force focused on delivering shots and treatments to a hesitant West Virginia populace. And while Justice opposed Covid vaccine mandates, especially for children, he vetoed state legislation earlier this year that would have eliminated vaccination requirements for students in virtual public schools and allowed private and religious schools to set their own standards.

“We think there might be a possibility there, based on that,” said Brad Woodhouse, president of the Democratic-aligned group Protect Our Care, which is behind the ad buys. “He’s had a position on vaccines that’s been pretty reasonable, and RFK doesn’t.”

Lauren caught up with Dr. Clay Marsh, who served as Justice’s Covid czar at the pandemic’s height, last month about how Justice might approach health policy in the Senate given his coronavirus experience. While Marsh said he expects Justice’s priorities to be energy and jobs, he noted the senator-elect’s focus on those issues as connected to the greater health and well-being of his state’s residents.

And with respect to vaccines: Marsh — now chancellor and executive dean of health science for West Virginia University, said “there’s lots of data” supporting the safety of vaccines.

“On balance, vaccines [are], other than probably clean water and handwashing during surgery, the most important elements that have been life-saving and life-sustaining” for public health, he said.

Justice has declined to comment on whether he’d vote to confirm Kennedy, though he’s signaled openness to Trump’s slate of nominees. A spokesperson didn’t respond to a request for comment.

GUTHRIE BUILDS OUT STAFF — Incoming House Energy and Commerce Chair Brett Guthrie (R-Ky.) is filling out top committee staff for the next Congress, POLITICO’s Ben Leonard reports.

Megan Jackson will be staff director, coming from biopharmaceutical firm Alkermes, where she was vice president of policy and government relations. Sophie Trainor Khanahmadi will be deputy staff director after serving as Guthrie’s chief of staff for the last three years.

Jackson lobbied on a number of issues, including the 340B drug discount program, community health centers and many provider-based rural health clinics and potential changes to the Inflation Reduction Act ’s Medicare drug price negotiation power.

 

A message from PBM Accountability Project:

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Eye on the FDA

WHERE’S THE FORMALDEHYDE BAN? The FDA’s long-awaited proposal to ban formaldehyde in hair-straightening products popular with women of color isn’t expected to be published before the Biden administration ends on Jan. 20.

The proposal, which the agency had aimed to release in September after first targeting the spring, is now slated for a March release, according to the fall 2024 unified regulatory agenda, which was quietly updated over the weekend.

An FDA spokesperson didn’t respond to a request for comment but previously called the effort a “high priority” for the agency.

“Communities of color, particularly women, continue to bear the brunt of exposure to these harmful chemicals, making timely action not just a regulatory priority, but a moral obligation,” Rep. Nydia Velázquez (D-N.Y.), who’s questioned the FDA about the delays, said in a statement.

It’s unclear whether the FDA under Trump would push to advance the proposal.

What’s recently cleared OMB: The White House office completed its review Friday of a final FDA rule that would set consumer education requirements for over-the-counter drugs beyond the label to ensure users can safely take them, according to the federal dashboard.

Industry Intel

NOVO, CATALENT ON VERGE OF CLOSING DEAL — Novo Holdings is on the verge of closing its transaction to acquire contract development manufacturing organization Catalent after receiving regulatory approvals.

The lack of Federal Trade Commission intervention means Novo Nordisk will likely be able to boost its production of its GLP-1 medicines, according to a research note from Capstone.

Pharma Moves

Mark Hartman, deputy director for programs in EPA’s Office of Pollution Prevention and Toxics, will become director of the FDA’s Office of Food Chemical Safety, Dietary Supplements and Innovation on Dec. 29, POLITICO’s E&E News reports.

Document Drawer

The Premium Cigar Association is scheduled to meet with the White House Office of Information and Regulatory Affairs on Wednesday to discuss the FDA’s pending maximum nicotine level proposed rule.

The Biden administration’s Fall 2024 Unified Agenda is out.

WHAT WE'RE READING

Few artificial intelligence medical devices have been authorized for kids, partly because of a lack of financial incentives, STAT’s Katie Palmer reports.

President-elect Donald Trump said he is a believer in the polio vaccine during a press conference Monday but dodged a question on whether he believes vaccines cause autism, a claim research has repeatedly debunked, POLITICO’s Megan Messerly reports.

 

A message from PBM Accountability Project:

There’s consensus in Congress – real PBM reform is needed NOW.

Both sides agree we need to: improve transparency, break the link that allows PBMs to tie their profits to the price of the drug, and force PBMs to share discounts with seniors.

Congress: It is time to finish the job and pass bipartisan senate bills 2973 and 3430. America’s seniors are counting on it. Learn more.

 
 

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David Lim @davidalim

Lauren Gardner @Gardner_LM

 

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