Analysis: RFK Jr vow to purge FDA sets up collision with Big Pharma

Ovid Therapeutics

15/11/2024 11:00

By Ahmed Aboulenein and Michael Erman
       WASHINGTON/NEW YORK, Nov 15 (Reuters) - Robert F.
Kennedy Jr. vowed to purge the U.S. Food and Drug Administration
shortly before being chosen as President-elect Donald Trump's
nominee for health secretary. Any changes he wants to make will
come up against a pharmaceutical industry that pays much of the
regulator's bills.
    Kennedy, an environmental activist who has helped sow doubts
about the safety and efficacy of vaccines, would have authority
over the nation's agencies responsible for public health,
government-funded health insurance plans for more than 140
million including the poor, those 65 and older, and the
disabled, medical research and more if confirmed as U.S.
Secretary of Health and Human Services.
        Kennedy has been most vocal about the FDA, an agency
that oversees nearly $3 trillion in medicines, food and tobacco
products. In interviews and on social media, Kennedy has accused
agency staff of doing the bidding of Big Pharma and Big Food.
    "FDA's war on public health is about to end," Kennedy wrote
on X in late October. "If you work for the FDA and are part of
this corrupt system, I have two messages for you: 1. Preserve
your records, and 2. Pack your bags."
    FDA officials were not immediately available to comment on
the Kennedy nomination.
    Shares of vaccine makers including Pfizer Inc  PFE.N , and
Moderna  MRNA.O , fell after news of Kennedy's appointment and
were down in after-hours trading by as much as 2%. 
    Calling the drug industry "a crown jewel of the American
economy," the Pharmaceutical Research and Manufacturers of
America, the leading industry lobby group, said in a statement
it wanted to work with the Trump administration to improve
health for patients.
    The group stressed achievements such as the elimination of
polio and smallpox, both of which were accomplished through
vaccination. It did not mention Kennedy by name in the
statement, released after the announcement.
    Del Bigtree, who was director of communications for
Kennedy's election campaign and remains close to the former
candidate, said he expected a careful look at any FDA employee
ties to industry.  
    "You're going to see a vetting process of, how do the people
have the jobs here? What were their conflicts of interest ...
you're going to watch a transparency that should have happened,"
he said. "And it's all going to be made public."
    Kennedy ran for president in this year's election as an
independent before dropping out in August and endorsing Trump in
exchange for a role in the Republican's administration.
    Making good on such pledges would require the new Trump
administration to strip federal employees of protections against
arbitrary firing put in place by lawmakers. The 18,000 FDA staff
are further shielded because their salaries are not exclusively
funded by Congress.
    In 2024, $3.3 billion, almost 46% of the agency's $7.2
billion budget, came from so-called "user fees," or payments
made by pharmaceutical and medical device manufacturers to fund
the staff resources needed to review their products quickly,
conduct inspections, and ensure the safety of clinical trials. 
    The FDA says user fees do not influence its decisions to
approve products, and its overall budget is still subject to
Congressional approval. Congress renews the user fee program
every five years and most recently extended its use through
September 2027. 
    Dan Troy, former chief counsel at the FDA under Republican
President George W. Bush's first administration, said he did not
expect any "seismic changes." 
    Even if Kennedy and other political appointees were able to
fire a substantial number of staff, "who are you going to put in
place? Who has the technical expertise to write these rules that
are going to really change the paradigm?" he said.
    
    REINFORCE THE GOOD
    Pharmaceutical executives have tried to mitigate concerns
over Kennedy's potential influence, and stressed the importance
of the agency's scrutiny of the safety and efficacy of
life-saving medications for everything from cancer to diabetes
and heart disease.
    "My hope, my belief, is people will see the good work the
FDA is doing today and continue to reinforce this," AstraZeneca
Plc  AZN.L  Chief Executive Pascal Soriot said earlier this
week. "The FDA has really been for many years not only the
reference in terms of regulatory authority in the world, but
also the most innovative and the fastest in approving medicines
that really are differentiated."
    Others were more blunt about their concerns about Kennedy's
long-held views.
    "Putting somebody in charge of any public health service who
is a vaccine denier puts at risk the stability of the nation at
large," Jeremy Levin, CEO of biotech company Ovid Therapeutics
 OVID.N  and a former chairman of biotech lobby group BIO told
Reuters late last month. "Vaccine denialism, which is a central
plank of RFK's, is perhaps as dangerous as anything as you could
imagine." 
    Levin described previous Trump appointees at the FDA and a
project overseeing the successful development of COVID-19
vaccines during his first term as "exceptional choices."
    "We have to hold on to the hope that anybody who gets put
into the position of the FDA director in a Trump administration
would be of the same quality," he said.
    In the meantime, FDA Commissioner Robert Califf sought to
reassure staff members following Trump's election last week.
    "There will, no doubt, be changes ahead, but rest assured,
the FDA will continue to do the job it was created to do," he
wrote in an email viewed by Reuters. "The work you do will
remain critical and this agency will continue to protect the
public, as it has for over a century."

 (Reporting by Ahmed Aboulenein in Washington and Michael Erman
in New York; Additonal reporting by Stephanie Kelly in New York
and Maggie Fick in London; Editing by Michele Gershberg and
Diane Craft)
 ((ahmed.aboulenein@thomsonreuters.com))