Could ACIP delay wind up in court?

Politico

25-02-2025

Driving The Day
ACIP LEGAL FALLOUT — The Trump administration's delay of what was supposed to be this week's regularly scheduled meeting of the CDC's vaccine advisers — and its anticipated overhaul of the panel — raised questions about what legal recourse drug companies and others might have.
As we've reported since now-HHS Secretary Robert F. Kennedy Jr.'s star rose with President Donald Trump's electoral win, the department head has vast discretion to remake the Advisory Committee on Immunization Practices — and Kennedy plans to replace at least some of them because of perceived conflicts of interest.
But it may not be so simple.
The CDC typically adopts the ACIP's recommendations, which have become an integral step in ensuring both clinical use and insurance coverage of newly approved vaccines.
References to the committee and its expected actions have been baked into federal and state laws — 2016's 21st Century Cures Act directs the panel to consider any new vaccines or indications at its next meeting following FDA approval, and 2022's Inflation Reduction Act requires ACIP-recommended shots covered under Medicare Part D to be offered at no cost to beneficiaries.
ACIP also votes on whether a pediatric vaccine should be added to the Vaccines for Children program, which offers shots at no cost to low-income kids.
'A court should most certainly look at the history and the context in addressing any action' that affects the committee's work, said Richard Hughes IV, a lawyer at Epstein Becker Green and a former Moderna executive.
Who has standing? While the FDA licenses new vaccines for the U.S. market, insurance coverage policies are usually tied to the ACIP's recommendations for their use. That means any delay to committee votes can have a material impact on uptake.
'How many doctors would consider recommending a $100 vaccine without professional [CDC] recommendation?' said Dorit Reiss, a vaccine law expert at the University of California College of the Law.
A spokesperson for GSK, which had two products slated for ACIP votes this week, didn't comment on whether the company would consider legal action over the meeting delay.
Is that your final answer? Any groups itching to get litigious would have to argue that the scrapping of the ACIP meeting is a 'final agency action.'
HHS' statement asserted that the cancellation is a 'postponement' to ensure the public has adequate time to comment before the meeting. While that likely buys the administration some time, drugmakers and others who want to see ACIP continue to make recommendations might have to decide at some point that the delay has morphed from temporary to indefinite — and thus a 'final' action.
'It's really hard to sue against nonaction, which is what this is,' Reiss said.
Reiss noted that the ACIP's next meeting is scheduled for June. 'How far can you postpone it without actually canceling it?' she asked. 'There's only a limited time they can claim this.'
IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Finally, some nice weather in the nation's capital.
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In the Courts
COMPOUNDERS STRIKE BACK — The FDA is on the receiving end of a new lawsuit from a group representing large facilities that make copies of brand-name drugs, which sued Monday over the agency's removal of diabetes and weight-loss drug semaglutide from its shortage list.
The Outsourcing Facilities Association, which has also challenged a similar agency decision for another weight-loss drug, argues that the FDA has ignored evidence that patients still have trouble accessing the drug and points to a recent financial disclosure from the manufacturer admitting that 'supply constraints' will continue.
As in its earlier suit challenging the removal of the GLP-1 tirzepatide from the shortage list, the association maintains the FDA should have conducted notice-and-comment rulemaking before changing the drug's status.
'An agency exhibiting due regard for law would have awaited the Court's forthcoming ruling before engaging in a similar delisting action to ensure its acts complied with law,' OFA said in the filing with a federal district court in Texas. 'FDA deliberately chose action to harm millions of patients without the benefit of this Court's ruling.'
The FDA didn't immediately respond to a request for comment.
Industry Intel
CAVAZZONI HEADS BACK TO PFIZER — Cue the revolving door debate.
Just over a week after HHS Secretary Robert F. Kennedy Jr. took office, the longtime pharmaceutical skeptic was dropped a political gift: Former top FDA drug regulator Patrizia Cavazzoni is headed to Pfizer to be its chief medical officer.
Before joining the FDA in January 2018 as the deputy director of operations in the agency's Center for Drug Evaluation and Research, Cavazzoni worked at Pfizer leading clinical sciences and development operations.
The move, which Kennedy's allies quickly seized on as an example of an improper relationship the FDA has with the industry it is tasked with regulating, also drew fire from those opposed to Kennedy.
Sen. Elizabeth Warren (D-Mass.) — a critic of Kennedy's vaccine skepticism — slammed the move as a poor decision by Cavazzoni that could erode trust in the FDA.
'When government officials cash in on their public service after leaving office, it degrades public trust and raises doubts about government's ability to work for people,' Warren said. 'That's why I've been so concerned about President Trump's picks with deep industry ties like RFK Jr. and Dr. Oz, and why I've pushed so hard to lock the revolving door.'
But former FDA Commissioner Robert Califf described Cavazzoni on Monday as a 'dedicated civil servant' who 'knows as much about drug development and drug safety as anyone on Earth.'
'Perhaps she retired because she saw the behavior of the current administration coming,' Califf told POLITICO. 'I'm glad her skills will be used to help people suffering from disease.'
Eye on the FDA
WAIT WAIT ... WE WANT YOU BACK — Several FDA employees have been asked to return to their jobs after being fired by the Trump administration, including medical device reviewers and people involved with inspections, according to four people familiar with the decision and granted anonymity to discuss the calls.
The reversal comes after the medical device industry raised concerns that the firings could delay the FDA's ability to review its products.
Spokespeople for the FDA and the White House did not respond to requests for comment.
In the Courts
PBMS APPEAL FTC CASE — The three largest pharmacy benefit managers on Friday appealed a district court loss that allowed the Federal Trade Commission's complaint against the companies' insulin pricing practices to move forward.
The pharmacy middlemen kicked their bid for a preliminary injunction up to the Eighth Circuit appellate court after a federal judge in Missouri denied their first attempt, determining the FTC was acting based on its congressional mandate.
The FTC sued those entities, which negotiate drug prices on insurers' behalf, in September, arguing they've illegally maximized profits by steering patients to more expensive insulins.
PBMs have argued they play an integral role as a counterparty against manufacturers to push down drug costs.
Document Drawer
Medicare Part D spending on 10 diabetes drugs increased 364 percent from $7.7 billion in 2019 to $35.8 billion in 2023, according to an HHS Office of Inspector General report released Monday.
WHAT WE'RE READING
Elizabeth Holmes lost an appeal to overturn her conviction, The Wall Street Journal's Meghan Bobrowsky reports.
House Energy and Commerce Democrats plan to force votes on members' support for Medicaid during a markup today of the panel's oversight plans — the same day the chamber is slated to vote on a budget resolution that would direct the panel to cut from programs under its jurisdiction, POLITICO's Ben Leonard reports.