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 The drugmaker's shares closed down 3% after the agency's acting
commissioner Janet Woodcock asked the Office of the Inspector
General at the Department of Health and Human Services to probe if
the talks were inconsistent with the regulator's policies.
"We received the letter and are reviewing it for appropriate
action," Tesia Williams, a spokesperson of HHS's Office of the
Inspector General, said in an email to Reuters.
The inspector general is an internal watchdog office tasked with
rooting out waste, fraud and abuse. It conducts audits and
evaluations to help track the effectiveness of HHS Department
programs and employs federal agents who conduct criminal
investigations.
The inspector general's findings are likely to lead to
recommendations for FDA management. They could potentially also lead
to discipline for some staffers. If criminal behavior is suspected,
the inspector general can potentially refer the matter for possible
prosecution to the Justice Department.
Biogen said it would cooperate with any inquiry in connection to a
possible review.
The drug, Aduhelm, was approved by the FDA on June 7 despite strong
objection from its expert advisory panel, resulting in the
resignation of three of its 11 members.
"There continue to be concerns raised ... regarding contacts between
representatives from Biogen and FDA during the review process,"
Woodcock said in a letter posted on Twitter. (https://bit.ly/3jY9wV3bit.ly)
[to top of second column] |
 Woodcock, however, said she had
"tremendous confidence" in the integrity of the
staff involved in the review of the drug.
Aduhelm was approved despite one of its two
large-scale clinical trials failing to show a
benefit to patients. The move
was based on evidence that it can reduce brain plaques, a likely
contributor to Alzheimer's disease, rather than proof that it slows
progression of the lethal mind-wasting disease.
Stifel analyst Paul Matteis said the latest development was unlikely
to impact Aduhelm's status as an approved drug.
"Dr. Woodcock's letter appears to be more of a maneuver to alleviate
pressure on FDA and it centers around the nature of
interactions/discussions, not the actual essence of the approval
decision," he said.
Memos released by the FDA last month showed a clear struggle within
the agency ahead of its controversial decision to approve Aduhelm.
After months of internal deliberations, agency officials cleared the
drug using its accelerated approval pathway, which required a study
to confirm that the drug works as intended.
(Reporting by Manas Mishra, additional reporting by Sarah Lynch and
Dania Nadeem; Editing by Arun Koyyur and Maju Samuel)
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