| Robert F. Kennedy Jr. had promised US senators there would be “radical transparency” at
the Department of Health and Human Services before he was confirmed as
its head. In his first address to staffers, Kennedy said the
agency’s data would be so open that no one would need to file a Freedom
of Information Act request, according to news reports. Yet
his department’s actions in his first two weeks has decreased
transparency around crucial vaccines used by millions of Americans. As my colleague Gerry Smith told you
yesterday, the Centers for Disease Control and Prevention postponed a
key meeting of the Advisory Committee on Immunization Practices. The
panel reviews data and makes recommendations that determine whether
insurers cover shots, and this meeting would have included examining
safety data behind vaccines for the RSV virus. Then
the Food and Drug Administration advisory panel that was supposed to
review the flu strains for next fall’s influenza shot was canceled. Scuttling this “critically important” meeting “is irresponsible, ignores science and shows a lack of concern,” Tina Tan, a pediatric infectious disease specialist and president of the Infectious Diseases Society of America, said. In phone
interview, Tan said the cancelation “jeopardizes the health of all the
American people,” if the vaccine ends up being delayed. The
agencies haven’t given a reason for the meeting changes. RFK Jr. has
suggested advisory panel members may have conflicts of interest. At
least with regards to the FDA’s vaccine advisory panel, the agency’s
staff would appear to disagree. The last time the vaccine panel convened
in October, the staff said none of the panel members had a conflict that needed to be waived. Tan said panel members are carefully vetted. In
an email Thursday, an HHS spokesperson confirmed the meeting
cancellation but emphasized the FDA would “make public its
recommendations to manufacturers in time for updated vaccines” to be
ready for the next flu season. It’s
true that FDA can make the decision on its own. Advisory panels don’t
issue binding decisions, and in the case of the influenza shot, the FDA
could choose to follow the World Health Organization’s recommendations
on what to put in the flu vaccine. But
advisory panels serve an essential role in publicly reviewing data and
guiding major regulatory actions. Eliminating the panels removes a key
layer of transparency in the FDA’s decision-making process. The
FDA can be opaque. Rules prevent the agency from revealing trade
secrets on unapproved drugs and vaccines. Yet advisory panels have an
exception to this confidentiality rule and are one of the few places
where FDA officials speak openly and in detail about specific drugs
still under review. They
also provide a way for members of the public, such as patients or
members of patients’ families, to weigh in on specific drugs and
vaccines. The
cancellation of this meeting raises concerns that other federal health
advisory panels may also be in jeopardy. Since President Donald Trump’s
inauguration, the FDA hasn’t posted any new advisory panel meetings on its website, and an advisory panel on surgical medical devices was postponed. By
this point last year, at least three FDA advisory panels had already
met, with three more officially scheduled for March, according to
archived versions of the agency’s website. If
RFK Jr. wants radical transparency, eliminating advisory panel meetings
that are the main public-facing portions of the drug review process is
the last thing he should be doing. — Robert Langreth |