Healthcare & Pharmaceuticals

U.S. review of Biogen Alzheimer's drug could have been handled better -FDA chief

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A sign marks a Biogen facility, some of whose employees have tested positive for the coronavirus after attending a meeting in Boston, in Cambridge, Massachusetts, U.S., March 9, 2020. REUTERS/Brian Snyder/File Photo/File Photo

July 14 (Reuters) - The U.S. Food and Drug Administration could potentially have done more to avoid the current controversies around its accelerated approval of Biogen Inc's (BIIB.O) Alzheimer's drug, Aduhelm, FDA acting Commissioner Janet Woodcock said during a Wednesday summit hosted by Stat.

The FDA last week called for an independent federal probe into its representatives' interactions with Biogen ahead of the regulator's approval of Aduhelm last month. read more

"The accelerated approval was based on very solid grounds," Woodcock said during Stat's Breakthrough Science Summit.

However, she said, "It is possible the process could have been handled in a way that would have decreased the amount of controversy involved."

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 last week.

During her interview with Stat, Woodcock also said COVID-19 booster shots are not needed in the United States at this time. She added that the FDA is still reviewing data to determine if boosters will be necessary in the future.

Woodcock said the FDA will not be able to sustain the speed at which it authorized COVID-19 medicines after the virus was first detected in the United States last year.

Woodcock said she is very engaged in reviewing e-cigarette regulatory submissions and hopes that the FDA will be able to provide more information on its reviews soon.

The FDA is working on new guidelines to reduce Americans' exposure to addictive opioid-based painkillers, she said, adding that recent federal funding for telehealth services could be important in combating addiction.

Reporting by Carl O'Donnell in New York and Trisha Roy in Bengaluru; Editing by Leslie Adler and Marguerita Choy

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