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The FDA’s accelerated approval
pathway will see major changes following December’s passage of the
Consolidated Appropriations Act, 2023 (2023 CAA), the latest version of the
annual legislation that funds the federal government. Experts say that the
changes should force drugmakers to be more diligent about proving the
clinical value of their early-stage pharmaceuticals — as long as the FDA uses
its enforcement powers.
Accelerated approval
withdrawals are rare
- According to an NPR
investigation, the FDA has withdrawn 28 accelerated approvals out of
hundreds that have been granted, and each withdrawal took an average of
seven years to complete.
- That fraught
process has come under scrutiny in recent months, as the FDA moved to
withdraw Covis Pharmaceuticals Inc.’s Makena (hydroxyprogesterone
caproate), a drug meant to reduce the incidence of preterm birth for
at-risk pregnant people. The drug was granted accelerated approval in
2011, but recent trials have not demonstrated that earned it earned the
designation.
- “The FDA has
said that it has failed to prove clinical benefit, so they sought to
withdraw it,” said Lauren Bloch, director of health policy and
regulatory affairs at Faegre Drinker LLP, during a Jan. 10 webinar on
the 2023 CAA. “That’s something that they have the authority to do, but
there was a good deal of controversy around whether there was really a
failure to prove clinical benefit, and whether it should have been kept
off the market.”
FDA gains more authority
to withdraw accelerated approval drugs
- That dispute
over the FDA’s authority, Bloch said, is one reason for the 2023 CAA’s
accelerated approval reforms.
- “Especially in
recent years, there have been questions about whether the FDA had clear
authority to take [withdrawal] actions related to accelerated approval,”
Bloch added. “The general thought was that they did, but that these
[powers] were vague.”
- The 2023 CAA is
meant to step up the FDA’s ability to track accelerated approval drugs
and withdraw unproven drugs from the market, according to a Jan. 10 post by
Joanne Hawana, an attorney at Mintz Levin PC. The FDA can now require a
drug sponsor to have a confirmatory trial underway before approval is
awarded, and drug sponsors must submit progress reports on post-approval
studies every six months, until the study is completed, among other
provisions.
FDA’S actions will
determine law’s success
- “I do think
it’s a step in the right direction, in terms of getting the FDA further
oversight,” Reshma Ramachandran, M.D., assistant professor of medicine
at Yale University, tells AIS Health.
- The reforms do
“at least put the ball in FDA’s court in terms of having a more
standardized process for withdrawing the drug,” Ramachandran says,
“instead of what we’re seeing now with Makena, where FDA is consistently
recommending withdrawal of the drug, but the sponsor has decided not to
go forward with voluntary withdrawal,” leading to an arbitration process
that is “taking forever.”
- But
Ramachandran says that giving the FDA more authority won’t solve all of
accelerated approval’s problems. The agency has to want to use that
authority.
- “A lot of it
will depend on implementation, because there’s still room for
flexibility for the sponsors,” Ramachandran says. Sponsors can “request
that FDA give them further discretion around completion of confirmatory
trials and what is going to lead to withdrawal.”
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