Legal questions swirl around FDA's new expedited drug program, including
who should sign off
[January 17, 2026]
By MATTHEW PERRONE
WASHINGTON (AP) — The Food and Drug Administration commissioner's effort
to drastically shorten the review of drugs favored by President Donald
Trump's administration is causing alarm across the agency, stoking
worries that the plan may run afoul of legal, ethical and scientific
standards long used to vet the safety and effectiveness of new
medicines.
Marty Makary's program is causing new anxiety and confusion among staff
already rocked by layoffs, buyouts and leadership upheavals, according
to seven current or recently departed staffers. The people spoke to The
Associated Press on the condition of anonymity because they were not
authorized to discuss confidential agency matters.
At the highest levels of the FDA, questions remain about which officials
have the legal authority to sign off on drugs cleared under the
Commissioner’s National Priority Voucher program, which promises
approval in as little as one month for medicines that support “U.S.
national interests.”
Traditionally, approval decisions have nearly always been handled by FDA
review scientists and their immediate supervisors, not the agency’s
political appointees and senior leaders.
But drug reviewers say they've received little information about the new
program's workings. And some staffers working on a highly anticipated
anti-obesity pill were recently told they can skip certain regulatory
steps to meet top officials' aggressive deadlines.
Outside experts point out that FDA drug reviews — which range from six
to 10 months — are already the fastest in the world.
“The concept of doing a review in one to two months just does not have
scientific precedent,” said Dr. Aaron Kesselheim, a professor at Harvard
Medical School. “FDA cannot do the same detailed review that it does of
a regular application in one to two months, and it doesn’t have the
resources to do it.”
On Thursday Reuters reported that FDA officials have delayed the review
of two drugs in the program, in part due to safety concerns, including
the death of a patient taking one of the medications.
Health and Human Services spokesman Andrew Nixon said the voucher
program prioritizes “gold standard scientific review” and aims to
deliver “meaningful and effective treatments and cures."
The program remains popular at the White House, where pricing
concessions announced by the Republican president have repeatedly been
accompanied by FDA vouchers for drugmakers that agree to cut their
prices.
For instance, when the White House announced that Eli Lilly and Novo
Nordisk would reduce prices on their popular obesity drugs, FDA staffers
had to scramble to vet new vouchers for both companies in time for
Trump's news conference, according to multiple people involved in the
process.
That’s sparked widespread concern that FDA drug reviews — long pegged to
objective standards and procedures — have become open to political
interference.
“It’s extraordinary to have such an opaque application process, one that
is obviously susceptible to politicization,” said Paul Kim, a former FDA
attorney who now works with pharmaceutical clients.
Top FDA officials declined to sign off on expedited approvals
Many of the concerns around the program stem from the fact that it
hasn't been laid out in federal rules and regulations.
The FDA already has more than a half-dozen programs intended to speed up
or streamline reviews for promising drugs — all approved by Congress,
with regulations written by agency staff.
In contrast, information about the voucher program is mostly confined to
an agency website. Drugmakers can apply by submitting a 350-word
“statement of interest.”
Increasingly, agency leaders such as Dr. Vinay Prasad, the FDA’s top
medical officer and vaccine center director, have been contacting
drugmakers directly about awarding vouchers. That’s created quandaries
for FDA staffers on even basic questions, such as how to formally award
a voucher to a company that didn’t request one.
Nixon, the HHS spokesman, said that voucher submissions are evaluated by
“a senior, multidisciplinary review committee,” led by Prasad.
Questions about the legality of the program led the FDA’s then-drug
director, Dr. George Tidmarsh, to decline to sign off on approvals under
the pathway, according to several people with direct knowledge of the
matter. Tidmarsh resigned from the agency in November after a lawsuit
challenging his conduct on issues unrelated to the voucher program.
After his departure, Dr. Sara Brenner, the FDA’s principal deputy
commissioner, was set to have the power to decide, but she also declined
the role after looking further into the legal implications, according to
the people. Currently the agency’s deputy chief medical officer, Dr.
Mallika Mundkur, who works under Prasad, is taking on the
responsibility.
Giving final approval to a drug carries significant legal risks,
essentially certifying that the medicine meets FDA standards for safety
and effectiveness. If unexpected safety problems later emerge, both the
agency and individual staffers could be pulled into investigations or
lawsuits.
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Dr. Marty Makary, commissioner of the Food and Drug Administration,
speaks during a press briefing at the White House, Wednesday, Jan.
7, 2026, in Washington. (AP Photo/Jacquelyn Martin)
 Traditionally, approval comes from
FDA drug office directors, made in consultation with a team of
reviewers. Under the voucher program, approval comes through a
committee vote by senior agency leaders led by Prasad, according to
multiple people familiar with the process. Staff reviewers don't get
a vote.
“It is a complete reversal from the normal review process, which is
traditionally led by the scientists who are the ones immersed in the
data,” said Kesselheim, who is a lawyer and a medical researcher.
Not everyone sees problems with the program. Dan Troy, the FDA’s top
lawyer under President George W. Bush, a Republican, says federal
law gives the commissioner broad discretion to reorganize the
handling of drug reviews.
Still, he says, the voucher program, like many of Makary’s
initiatives, may be short-lived because it isn't codified.
“If you live by the press release then you die by the press
release,” Troy said. “Anything that they’re doing now could be wiped
out in a moment by the next administration.”
The voucher program has ballooned after outreach by FDA officials
Initially framed as a pilot program of no more than five drugs, it
has expanded to 18 vouchers awarded, with more under consideration.
That puts extra pressure on the agency’s drug center, where 20% of
the staff has left through retirements, buyouts or resignations over
the past year.
When Makary unveiled the program in October there were immediate
concerns about the unprecedented power he would have in deciding
which companies benefit.
Makary then said that nominations for drugs would come from career
staffers. Indeed, some of the early drugs were recommended by FDA
reviewers, according to two people familiar with the process. They
said FDA staffers deliberately selected drugs that could be vetted
quickly.
But, increasingly, selection decisions are led by Prasad or other
senior officials, sometimes unbeknownst to FDA staff, according to
three people. In one case, FDA reviewers learned from
GlaxoSmithKline representatives that Prasad had contacted the
company about a voucher.
Access to Makary is limited because he does not use a government
email account to do business, according to people familiar with the
matter, breaking with longstanding precedent.
Under pressure from drugmakers, some FDA reviewers were told they
can skip steps
Once a voucher is awarded, some drugmakers have their own
interpretation of the review timeline — creating further confusion
and anxiety among staff.
Two people involved in the ongoing review of Eli Lilly's
anti-obesity pill said company executives initially told the FDA
they expected the drug approved within two months.
The timeline alarmed FDA reviewers because it did not include the
agency's standard 60-day prefiling period, when staffers check the
application to ensure it isn’t missing essential information. That
60-day window has been in place for more than 30 years.
Lilly pushed for a quicker filing turnaround, demanding one week.
Eventually the agency and the company agreed to a two-week period.
Lilly's CEO, David Ricks, told attendees at a health care conference
on Tuesday that the company expects FDA approval of its pill in the
second quarter of the year.
Nixon declined to comment on the specifics of Lilly's review but
said FDA reviewers can “adjust timelines as needed.”
Staffers were pushed to keep the application moving forward, even
though key pieces of data about the drug's chemistry appeared to be
missing, according to one person involved in the process. When
reviewers raised concerns about gaps in the application, the person
said, they were told by a senior FDA official that it was OK to
overlook the regulations if the science is sound.
Former reviewers and outside experts say that approach is the
opposite of how FDA reviews should work: By following the
regulations, staffers scientifically confirm the safety and
effectiveness of drugs.
Skipping review steps could also carry risks for drugmakers if
future FDA leaders decide a drug wasn’t properly vetted. Like other
experts, Kesselheim says the program may not last beyond the current
administration.
“They are fundamentally changing the application of the standards,
but the underlying law remains what it is,” he said. “The hope is
that one day we will return to these scientifically sound, legally
sound principles.”
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