President Joe Biden recently nominated former FDA Commissioner
Robert Califf, M.D., to run the agency once more, ending nearly a year of
temporary leadership under Acting Commissioner Janet Woodcock,
M.D. Califf previously led the FDA during the Obama administration,
running the agency for roughly the last two years of Obama’s
term. Califf advocates for using “real-world evidence” in addition to
clinical trial data in medication approvals. And according
to one industry insider, Califf might look to reform and improve the
accelerated approval pathway following the controversial Aduhelm (aducanumab)
approval earlier this year.
Speedy Approvals May Be Reformed
- Kelly George, Ph.D., an associate principal at Avalere
Health, tells AIS Health that the accelerated approval process does
meet an important need despite recent controversies, such as
the approvals of Aduhelm and Sarepta Therapeutics’ eteplirsen.
- "The point of accelerated approval is being able
to potentially meet patients’ needs while we’re gathering more data,”
George says. “If there’s a suggestion of efficacy, there’s a suggestion of
a patient benefit, we’d rather have something on the market than
nothing.”
- “There’s certainly a number of conversations about
improving the process,” George adds. “Instead of products continuing to
stay in the market until FDA does something, you could switch the burden
and say the sponsor [company] automatically loses market access at a
certain point, unless FDA does something.”
Can Califf Move the Agency Forward?
- George believes that Califf’s ability to
“move the agency forward” in real-world evidence “is fantastic. The thing
about real-world evidence, which may not be applicable to Califf, is
it pulls the power away from sponsors and into...stakeholders’
hands.”
- “What Califf does in this space is he brings expertise
in both real-world evidence and clinical trials.…Those are two fantastic
ways to get data on a drug more quickly and efficiently. You can do
real-world evidence, once we have our feet on the ground in that space —
presumably you can do it cheaper and quicker."
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