Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Fierce Healthcare, in “RFK Jr.'s Vaccine Advisory Overhaul Undermines Vaccine Confidence, Experts Say,” by Dave Muoio.

Following is an excerpt:

Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s removal of all 17 sitting members of a key vaccine advisory panel has ignited criticism from medical associations and experts as well as concerns that the promised replacements won’t be trustworthy.

The secretary announced the move Monday afternoon, describing the decision to upend the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) as “prioritizing the restoration of public trust.”

He noted that the Biden administration had appointed all 17 of the members, including 13 in 2024, and that the Trump administration would not have the ability to appoint a majority of the committee until 2028 if their terms were allowed to expire.

“A clean sweep is necessary to reestablish public confidence in vaccine science,” said RFK Jr., who has often described government health advisors, researchers and others as compromised by the pharmaceutical industry. “ACIP's new members will prioritize public health and evidence-based medicine. The Committee will no longer function as a rubber stamp for industry profit-taking agendas.”

RFK Jr. had made several concessions to lawmakers during his confirmation process regarding vaccine policy. Of particular note, Sen. Bill Cassidy, M.D., R-La., shared in a floor speech that the secretary had promised to “maintain the [CDC’s ACIP] without changes.”

Within hours and through Tuesday, healthcare groups, medical experts and lawmakers condemned RFK Jr.’s announcement as a breach of his promise and a danger to children and adults’ health.

“Today’s action to remove the 17 sitting members of ACIP undermines that trust and upends a transparent process that has saved countless lives,” American Medical Association (AMA) President Bruce Scott, M.D., said in a Monday statement. “With an ongoing measles outbreak and routine child vaccination rates declining, this move will further fuel the spread of vaccine-preventable illnesses.”

Similar comments came in statements from:

  • Infectious Diseases Society of America President Tina Tan, M.D., who called allegations on the ACIP’s integrity “completely unfounded;”
  • American Academy of Pediatrics President Susan Kressly, M.D., who described “an escalating effort by the administration to silence independent medical expertise and stoke distrust in lifesaving vaccines;” and
  • American Academy of Physician Associates President Jason Prevelige, who said the move was “deeply damaging to confidence in vaccines that have proven to be safe for decades and in the healthcare providers who counsel patients and their families about immunization decisions every day.”

Paul Offit, M.D., director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a former ACIP member, outlined a series of vaccines greenlighted by the committee within the past 25 years that have had substantial positive impacts on disease incidence.

These included a vaccine for rotavirus “that virtually eliminated the 70,000 hospitalizations from severe dehydration caused by that virus,” an HPV vaccine that cut U.S. cervical cancer incidence by 60% and a respiratory syncytial virus vaccine for mothers that cut hospitalizations from the virus during the first two months their infants' lives by more than half.

"I think RFK Jr. is fixing a problem that doesn’t exist,” Offit told Fierce Healthcare. “The ACIP has served us well. He can point to no specific instance where an ACIP voting member has been unduly influenced by the pharmaceutical industry that has caused them to vote against the data. It’s just all innuendo and conspiracy.”

Tom Frieden, M.D., who previously served as director of the CDC, described RFK Jr.’s “dangerous and unprecedented action” of axing the committee members as politization that will “undermine public trust under the guise of improving it.” Should the change lead to vaccines no longer being recommended, “millions of people could lose access [and] pay more for vaccines … for preventable illness, and children will be at greater risk of diseases we haven’t faced in decades.”

What's next for ACIP

Richard Hughes, a healthcare attorney at Epstein Becker Green, said RFK Jr. does have the statutory discretion to set the terms and qualifications for the committee and is permitted to remove a member—though he acknowledged that this decision “could be subject to a challenge under the Administrative Procedure Act on the basis that it is arbitrary and capricious.”

Hughes went on to note that a new ACIP could change existing recommendations, which are tied to coverage obligations under private health insurance, Medicaid and Medicare Part D, though Medicare’s vaccines are specified in statute. The ACIP also determines the vaccines that must be included in the Vaccines for Children program, which provides all recommended vaccines against 19 different diseases to low-income or underinsured minors at no cost, he said.

RFK Jr.’s announcement affirmed the ACIP would convene its next meeting June 25, setting up a tight timeline for the committee to continue its work. An agenda for that meeting has not yet been published.

Pointing to RFK Jr.’s prior affiliations with vaccine skepticism activists and more recent stumbles on vaccine-preventable diseases like measles since stepping into government, multiple experts and organization heads raised doubts about the qualifications and motives of those who will be tapped to fill the empty roles.

“I think RFK Jr. is just picking up the phone and calling people, and saying ‘you’re in,’” Offit said. “… Will they be people who are like-minded to him? How will the public, meaning medical professionals and scientists, look at that advice? Will they not be able to trust it because he won’t bring in people who have expertise in the field?"

Hughes said it’s likely that new members “will be drawn from fringe ‘medical’ and ‘public health’ groups and overtly anti-vaccine organizations.” He added that the June meeting “is likely to be upended by objections to CDC statements and presentations, misstatements of science and proactive attempts to eliminate or change recommendations.”

The secretary has “opened the door for fringe theories rather than facts to guide the recommendations that doctors rely on to protect patients,” Frieden said.

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