FDA to offer faster drug reviews to companies promoting 'national
priorities'
[June 18, 2025]
By MATTHEW PERRONE
WASHINGTON (AP) — U.S. regulators will begin offering faster reviews to
new medicines that administration officials deem as promoting “the
health interests of Americans,” under a new initiative announced
Tuesday.
Food and Drug Administration Commissioner Marty Makary said the agency
will aim to review select drugs in one to two months. FDA's
long-standing accelerated approval program generally issues decisions in
six months for drugs that treat life-threatening diseases. Regular drug
reviews take about 10 months.
Since arriving at the FDA in April, Makary has repeatedly told FDA staff
they need to “challenge assumptions” and rethink procedures. In a
medical journal commentary published last week, Makary suggested the
agency could conduct “rapid or instant reviews," pointing to the
truncated process used to authorize the first COVID-19 vaccines under
Operation Warp Speed.
For the new program, the FDA will issue a limited number of “national
priority vouchers” to companies “aligned with U.S. national priorities,”
the agency said in a statement. The special designation will give the
selected companies access to extra FDA communications, streamlined staff
reviews and the ability to submit much of their product information in
advance.
Speeding up drug approvals has long been a priority of the
pharmaceutical industry, which has successfully lobbied Congress to
create a variety of special programs and pathways for faster reviews.
Many aspects of the plan announced Tuesday overlap with older programs.
But the broad criteria for receiving a voucher will give FDA officials
unprecedented discretion in deciding which companies can benefit from
the fastest reviews.
"The ultimate goal is to bring more cures and meaningful treatments to
the American public,” Makary said in a statement.
Makary said he will prioritize vouchers for companies pursuing products
that address health crises, deliver “innovative cures” or address other
unmet public health needs.
An administration official said the program wouldn't change FDA approval
standards.
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Food and Drug Administration (FDA) commissioner Marty Makary speaks
during a news conference at the Hubert Humphrey Building Auditorium
in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, file)
 “Without altering how new treatments
are evaluated — just when — the FDA’s new voucher program is a
common sense reform that maintains rigorous clinical standards while
streamlining needless bureaucracy," Kush Desai, a White House
spokesperson, wrote in an emailed statement Tuesday.
Separate from this week's announcement, Makary recently suggested
the FDA should be willing to ease its scientific requirements for
certain drugs targeting rare conditions. In such cases, the agency
could consider waiving its requirement for randomized studies, in
which researchers track patients over time to evaluate drug safety
and effectiveness. Such trials are generally considered the gold
standard of medical research, though the FDA has increasingly been
willing to accept smaller, less-definitive studies for rare or
life-threatening diseases.
In several recent cases, the FDA has faced criticism for approving
drugs based on preliminary data that didn't ultimately show benefits
for patients.
The push to rapidly accelerated drug approvals is the opposite
approach that Makary and his boss, Health Secretary Robert F.
Kennedy Jr., have taken on vaccines.
Promising a “return to gold-standard science,” Kennedy previously
announced that all new vaccines would have to be compared to
placebo, or a dummy shot, to win approval. Kennedy and Makary also
have announced a stricter policy on seasonal updates to COVID-19
shots, saying they will have to undergo new testing before they can
be approved for use in healthy children and most adults.
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