RFK Jr. eyes loophole for autism vax injury claims
VICP CHANGES COMING — Health Secretary Robert F. Kennedy Jr. is working on policy changes to the Vaccine Injury Compensation Program that would allow families of children with autism to seek awards from the $4.5 billion fund it administers, Lauren reports.
While the prospect of such a change isn’t exactly surprising — it’s been telegraphed by Kennedy for months — one of his top advisers on vaccine policy outlined HHS’s thinking publicly Thursday with the most detail to date at a panel discussion on autism hosted by the MAHA Institute, a group that boosts the secretary’s agenda.
“Part of what Secretary Kennedy is doing right now — and with my help, and we have a team looking at it — is we have to figure out a way to capture these kids,” said Drew Downing, a longtime vaccine injury lawyer who’s now a senior HHS adviser.
“If you don’t want to use the ‘A word,’ whatever, that’s fine,” he said, referring to autism. “How do we capture them: Do we broaden the definition of encephalopathic events? Do we broaden neurological injuries? How do we do that?”
The potential: Renee Gentry, director of George Washington University’s Vaccine Injury Litigation Clinic, said a broader definition of encephalopathy that would allow some children with brain injuries and autism-like symptoms to be compensated could benefit both public health and the drug industry — without explicitly naming autism as an injury.
A so-called table injury — a specific health outcome that occurs within a defined time period post-vaccination and is recognized by HHS — should give families quicker access to compensation and mitigate legal costs for vaccine makers, Gentry said. She noted that claims of post-vaccination brain injury that resulted in symptoms of autism were compensated before a 2000s-era legal effort in which the vaccine court denied compensation to a group of families alleging vaccines had caused their children’s autism, determining the science didn’t back their claims.
“Autism is always the third rail in these discussions, but it shouldn’t be,” Gentry said. “The best thing for the manufacturers would be to get as many injuries listed on the table as possible.”
The caution: VICP advocates have warned that adding autism to the list of injuries for which the court readily compensates petitioners would crush it, creating an unmanageable workload for the federal agencies administering it and bankrupting its pharma-funded trust fund.
However, the effects of amending what’s considered brain dysfunction that’s eligible for compensation are unclear.
It’s “hard to know how that would play out,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “It depends on how the special masters interpret it.”
IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We’re going to leave this story about the Tylenol tweet heard ’round the world — eight years later — here.
SHOT-SIGHTED — Health Secretary Robert F. Kennedy Jr. has a big vaccine decision to make after last week’s vaccine meeting in Atlanta — and he has broad authority to go big, Lauren, Sophie Gardner and Tim Röhn report.
The CDC typically approves changes to the vaccine schedule teed up by its Advisory Committee on Immunization Practices, which last week made decisions that — at least on the surface — appeared surprising for a group whose members Kennedy had handpicked.
Kennedy, either directly or through acting CDC Director Jim O’Neill, has the power to accept or reject the ACIP’s recommendations — which, if approved, wouldn’t alter the vaccine schedule as much as many public health advocates expected. But he could also create new recommendations without a vote from the panel, giving him broad authority over the childhood vaccine schedule — though there’s little precedent for such a move.
President Donald Trump appears to have further complicated Kennedy’s decision-making by pushing dramatic changes to the vaccine schedule at a White House event on Monday to address a supposed connection between Tylenol use by pregnant women and autism.
What’s next: The CDC’s decision could come any day now, but it’s unclear when exactly it will be announced or which way Kennedy is leaning. HHS spokesperson Andrew Nixon noted that the recommendations become “part of the CDC immunization schedule if it is adopted by the CDC director” but declined to comment on Kennedy’s timing.
Even so: Many public health advocates are worried.
“I think has ultimate power in terms of these sorts of things,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a former ACIP member. “That’s what makes it all so frightening, because he’s a man on a mission, and his mission is to make vaccines less available, less affordable.”
Key context: There’s precedent for HHS ignoring its vaccine advisers. Then-CDC Director Rochelle Walensky overruled the committee in 2021 to recommend third doses of Covid-19 vaccines to a broader group of people than the panel had recommended.
But Dr. Richard Besser, an acting CDC director under then-President Barack Obama, said Walensky’s decision was understandable during the pandemic.
“Dr. Walensky’s decision expanded eligibility for potentially life-saving vaccines,” he said in an email. “Secretary Kennedy, on the other hand, seems determined to restrict access as much as he can.”
Drug Pricing
TRUMP’S NEW DRUG TARIFF — President Donald Trump announced the U.S. will impose a 100 percent tariff on “any branded or patented” drug product starting Oct. 1 in a Truth Social post late Thursday.
But there’s a big caveat: There will be a carveout for companies that are building a manufacturing plant in the U.S. — specifically, drugmakers that have broken ground or have a plant under construction.
“There will, therefore, be no Tariff on these Pharmaceutical Products if construction has started,” Trump posted.
PhRMA spokesperson Alex Schriver said many brand drugmakers are announcing “hundreds of billions in new U.S. investments” due to Trump’s tax and regulatory policies.
“Tariffs risk those plans because every dollar spent on tariffs is a dollar that cannot be invested in American manufacturing or the development of future treatments and cures,” Schriver said in a statement. “Medicines have historically been exempt from tariffs because they raise costs and could lead to shortages.”
ASTRAZENECA’S SCOTUS ASK — British drugmaker AstraZeneca is petitioning the Supreme Court to review its challenge to the Inflation Reduction Act’s Medicare drug price negotiations.
The 3rd Circuit U.S. Court of Appeals in May upheld a district court ruling that rejected the company’s arguments challenging the program’s constitutionality. Multiple drugmakers have lost various challenges to the drug price talks.
“We believe this step is necessary to support and improve patients’ access to future life-saving medicines, and our rights as a company,” an AstraZeneca spokesperson said in a statement.
In Congress
SHUTDOWN WATCH — The government is hurdling closer to a potential shutdown — and the White House Office of Management and Budget is directing federal agencies to prepare reduction-in-force plans for mass firings for a possible interruption in funding.
While the FDA historically has planned for vast swaths of employees to be retained during a shutdown — 77 percent in its fiscal 2025 contingency staffing plan — OMB is looking to target employees who work in programs that are not legally required to continue.
Mitch Zeller, former director of the FDA’s Center for Tobacco Products, said any attempt to use a possible shutdown as an excuse to impose further staffing cuts at the FDA would harm its workforce and further erode morale.
“It will accelerate departure from government by those who had retained the option of staying. It will increase early retirements,” Zeller said. “And it will increase the number of FDA employees who take jobs with the industries they regulate.”
Industry Intel
232 TARIFFS ... ON MEDICAL DEVICES? The Commerce Department has opened a national security investigation that could result in new duties on imports of medical devices, paving the way for an even broader expansion of President Donald Trump’s tariffs, POLITICO’s Ari Hawkins reports.
On Thursday, AdvaMed CEO Scott Whitaker said the medical device trade lobby will continue to work with the Trump administration, adding that the U.S. medtech industry supplies about 70 percent of the domestic market.
“We believe this process will reinforce the fact that U.S. medtech manufacturing is strong and lower tariffs will fuel more manufacturing and job growth in the U.S., which means greater access to lifesaving technologies and lower costs to American hospitals and patients,” Whitaker said.
The American Medical Manufacturers Association praised the administration’s investigation into personal protective equipment, medical consumables and medical equipment.
“America cannot protect its frontline workers, healthcare workers or citizens without a resilient, homegrown manufacturing base for critical supplies,” AMMA Executive Director Eric Axel said in a statement. “Now is the time for domestic makers to step up, tell their stories, and advocate for the policies that give us a fighting chance to lead and serve our communities.”
CAPRICOR PREPARES TO RESUBMIT — San Diego-based Capricor Therapeutics said Thursday it recently met with the FDA to discuss the agency’s complete response letter for Deramiocel, the company’s investigational cell therapy for Duchenne muscular dystrophy.
The company said it aligned with the agency on endpoints for its HOPE-3 pivotal trial.
“Capricor plans to submit HOPE-3 data with its complete response to the CRL, with the goal of securing a label encompassing both cardiac and skeletal muscle function in DMD,” the company said in a news release.
Document Drawer
CMS has a proposed rule for a “Global Benchmark for Efficient Drug Pricing (GLOBE) Model” under review as of Thursday at the White House Office of Information and Regulatory Affairs.
The FDA published a series of gene-therapy draft guidances on expedited development and review, methods to capture product safety and efficacy data after approval and innovative clinical trial designs for the therapies in small populations.
WHAT WE'RE READING
Long-acting HIV protection drug lenacapavir will be made available for $40 annually per patient in low- and middle-income nations, under deals struck by philanthropies, The New York Times’ Apoorva Mandavilli reports.
The United Kingdom is pushing forward to become a hub for mRNA research amid a U.S. drawback, STAT’s Andrew Joseph reports.