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Nearly 80-Year-Old Law Could Hinder RFK Jr.'s Push to Create New Vaccine Program |

Nearly 80-Year-Old Law Could Hinder RFK Jr.'s Push to Create New Vaccine Program |

As secretary of the Department of Health and Human Services (HHS), Robert F. Kennedy Jr. has broad authority to set federal vaccine policy.In June, he fired all 17 members of the committee that affects vaccine policy and then chose their...

Nearly 80-Year-Old Law Could Hinder RFK Jrs Push to Create New Vaccine Program

As secretary of the Department of Health and Human Services (HHS), Robert F. Kennedy Jr. has broad authority to set federal vaccine policy.In June, he fired all 17 members of the committee that affects vaccine policy and then chose their replacements.In August, he fired the director of the Centers for Disease Control and Prevention (CDC) after controversy over the vaccine.

But even Kennedy's authority has its limits.

The unanimous decision to scrap the US childhood vaccine schedule and replace it with recommendations from Denmark, as Kennedy prepared to do last week, was more than just a press conference, legal experts told The News.

Kennedy and other agency leaders must adhere to the Administrative Procedure Act (APA), a law passed by Congress that requires the federal government to follow an open, consultative process when issuing rules and regulations, said Lawrence Gostin, JD, director of the O'Neill Institute for National and Global Health Law at Georgetown University.

"As a matter of law, Secretary Kennedy has the ultimate authority to make federal policy," Gostin said."But he has to follow a reasonable process."

Efforts to reduce the number of vaccinations

Kennedy's announcement was canceled at the last minute.​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ You have been accused by the DOJ Public Affairs Office of releasing the Kenpi children to send Faran Piliar on vacation, which was both legally and politically risky.

In an email to the media, HHS suggested postponing the press conference, saying it "delays our children's health announcement until the first day of the new year."

An HHS spokesman declined to say whether Kennedy planned to change the vaccination schedule at the news conference.

Kennedy, a longtime anti-vaccination activist, has made no secret of his zeal for changing the vaccination schedule.

But Dorit Reyes, a law professor at the University of California, San Francisco, said Kennedy must proceed carefully to prevent the judge from making any policy changes.

By law, Secretary Kennedy has the ultimate authority to set federal policy....but he must follow due process.

According to the APA, courts "may unlawfully stay and set aside agency actions, findings, and conclusions and may conclude that they are arbitrary, capricious, an abuse of discretion, or otherwise inconsistent with law."

Holding a press conference to announce that the U.S. is now recommending Denmark's vaccination plan leaves the Trump administration "very vulnerable to an arbitrary and capricious statement," Rees said."Short videos just don't cut it."

Follow the given steps.

For more than six decades, vaccination recommendations have been developed by the Advisory Committee on Immunization Practices (ACIP), which often votes on national recommendations after reviewing medical evidence and soliciting input from experts and the public. The CDC director can accept or reject those recommendations.

CDC recommendations are not mandates.Even if Kennedy were to change current vaccine recommendations to match Denmark's recommendations, states would not have to follow them.While CDC recommendations carry a lot of weight, states make individual decisions about school vaccine requirements, Gostin said.

The court is likely to take a dim view of any changes in federal vaccination policy that do not go through ACIP, Reiss said.

If the government wants to follow Denmark's example, "they need to address the fundamental issues and explain why they are changing from a plan that has been drawn up after years of consultation."

And Trump's invitation has no legal weight, Reiss added.

"The president's memo is not covered because the president's will is not sufficient to justify a change of position under Supreme Court case law," Reese said."The agency also has to justify the decision on the merits."

Legal challenges to Trump administration policies

Many lawsuits filed against the Trump administration in recent months allege that he and the heads of federal agencies violated the APA.

The American Academy of Pediatrics (AAP) and other medical groups, for example, filed a lawsuit against Kennedy in July, claiming he violated the APA when he issued a directive removing the COVID-19 vaccine from the CDC's vaccination program for children and pregnant women.

"The concerns and the legal questions are whether he followed the process and looked at the evidence," said Richard H. Hughes IV, JD, MPH, who teaches vaccine studies at George Washington University and represents the AAP and other plaintiffs in their lawsuit against Kennedy.

Many medical associations and public health groups have criticized Kennedy and the ACIP for recent changes to the vaccine schedule, such as dropping the recommendation that all newborns be routinely vaccinated against hepatitis B.Scientists and public health advocates predict that this decision will allow many children to contract and die from vaccine-preventable diseases.

Neither Kennedy "nor ACIP took the appropriate steps to evaluate the full evidence that is routinely reviewed before issuing recommendations," Hughes said."All of this is textbook 'arbitrary and capricious' under the Administrative Procedure Act."

But that doesn't mean Kennedy can't find other ways to change the vaccine schedule, Gostin said.

Gostin said that if he follows the deliberative process, the final decision is his.

While the APA could be interpreted to mean that Kennedy should work with ACIP to change vaccine recommendations, "that's not a major drawback for Kennedy because he carefully selected ACIP members," Gostin said.

Justifying a change in vaccine recommendations is easier than changing federal regulations, a process that typically takes months and includes proposals and opportunities for public comment, Gostin said.

Kennedy would have more difficult procedures to follow if he proposed a legal regulation, Gostin said.

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