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 Aaron Kesselheim, a Professor of Medicine at Harvard Medical School
who had served on the FDA’s advisory committee for nervous system
drugs since 2015, told Reuters on Thursday he was stepping down from
the panel.
"My rationale was that the FDA needs to re-evaluate how it solicits
and uses the advisory committees ... because I didn’t think that the
firm recommendations from the committee in this case ... were
appropriately integrated into the decision-making process,"
Kesselheim said in an email.
He cited FDA's decision to approve Sarepta Therapeutic Inc's drug,
eteplirsen, for Duchenne muscular dystrophy in 2016 as another
example of the regulator approving a drug against the
recommendations of its advisory committee.
Stat News first reported his departure.
On Tuesday, a member of the advisory group who voted against the
approval, Washington University neurologist Dr. Joel Perlmutter,
resigned from the committee, citing the FDA's approval of Aduhelm.
[to top of second column] |
 Mayo Clinic neurologist Dr.
David Knopman said he resigned on Wednesday.
The 11-member committee voted nearly unanimously
in November that Biogen's drug should not be
approved, citing inconclusive evidence that the
drug was effective.
The FDA on Monday gave the drug "accelerated
approval,” based on evidence that it can reduce
a likely contributor to Alzheimer’s, rather than
proof of a clear benefit against the disease.
(Reporting by Julie Steenhuysen and Carl
O'Donnell; editing by Grant McCool)
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