Post by icemandios on Feb 4, 2022 16:29:07 GMT
February 4, 2022 07:23 AM EST Pharma
SEC and FTC open two more investigations into Biogen's controversial Alzheimer's drug approval and marketing practices
Zachary Brennan
Senior Editor
Following Biogen’s announcement of miniscule 2021 sales for its controversial new Alzheimer’s drug yesterday, the company also revealed that the Federal Trade Commission and the Securities and Exchange Commission have opened two new, separate investigations into the troubled biotech.
The FTC, an antitrust regulator, has requested documents related to a civil investigative demand, similar to a subpoena, on the marketing and approval of the Alzheimer’s drug.
The FDA signed off on Aduhelm via its accelerated approval pathway, after an outside group of experts nearly unanimously called for the drug to be rejected as the company had yet to establish a link between the results from their studies and patient benefit.
In addition, Biogen newly disclosed on Thursday that the SEC is also seeking information relating to Aduhelm, also on its approval and marketing.
Earlier last month, Endpoints News brought readers inside of an internal sales call, in which executives stressed that their teams should continue to sell the drug, despite CMS issuing a draft national coverage decision saying that the drug should only be covered in CMS-approved clinical trials.
Exclusive: Biogen leaders warn sales teams: Only 2,000 patients might access Aduhelm over the next several years
Brendan Manquin
According to a recording of the Zoom call with sales teams, obtained by Endpoints, Biogen VP of US market access and reimbursement Brendan Manquin slammed the implications of the draft NCD, and said it means that even if Biogen runs a large, randomized placebo-controlled Phase III trial, on the order of 2,000 to 3,000 patients (with 33-50% on placebo), only about 1,000 to 2,000 patients will access Aduhelm “over the next several years.”
Three other investigations into Biogen’s Aduhelm are ongoing as concerns were raised early on regarding the close ties between the Billy Dunn, director of FDA’s office of neuroscience, and Biogen execs. Dunn’s deputy Eric Bastings also recently departed the FDA for a role as VP of development strategy at Ionis Pharmaceuticals, a company with close ties to Biogen.
The FDA is conducting its own internal investigation and another is being conducted by the US House committees on oversight and energy & commerce. The congressional investigation launched in July, as representatives sought from the company a variety of different internal and external documents and communications relating to assessments of Aduhelm’s safety, efficacy, and clinical benefit.
House committees kick off investigation into how Biogen's Aduhelm won approval
At the request of acting FDA commissioner Janet Woodcock, the Office of Inspector General of HHS also is investigating Aduhelm and the accelerated approval pathway in general.
Findings from the HHS investigation aren’t expected until next year, and the timelines on the other investigations have yet to be announced.
SEC and FTC open two more investigations into Biogen's controversial Alzheimer's drug approval and marketing practices
Zachary Brennan
Senior Editor
Following Biogen’s announcement of miniscule 2021 sales for its controversial new Alzheimer’s drug yesterday, the company also revealed that the Federal Trade Commission and the Securities and Exchange Commission have opened two new, separate investigations into the troubled biotech.
The FTC, an antitrust regulator, has requested documents related to a civil investigative demand, similar to a subpoena, on the marketing and approval of the Alzheimer’s drug.
The FDA signed off on Aduhelm via its accelerated approval pathway, after an outside group of experts nearly unanimously called for the drug to be rejected as the company had yet to establish a link between the results from their studies and patient benefit.
In addition, Biogen newly disclosed on Thursday that the SEC is also seeking information relating to Aduhelm, also on its approval and marketing.
Earlier last month, Endpoints News brought readers inside of an internal sales call, in which executives stressed that their teams should continue to sell the drug, despite CMS issuing a draft national coverage decision saying that the drug should only be covered in CMS-approved clinical trials.
Exclusive: Biogen leaders warn sales teams: Only 2,000 patients might access Aduhelm over the next several years
Brendan Manquin
According to a recording of the Zoom call with sales teams, obtained by Endpoints, Biogen VP of US market access and reimbursement Brendan Manquin slammed the implications of the draft NCD, and said it means that even if Biogen runs a large, randomized placebo-controlled Phase III trial, on the order of 2,000 to 3,000 patients (with 33-50% on placebo), only about 1,000 to 2,000 patients will access Aduhelm “over the next several years.”
Three other investigations into Biogen’s Aduhelm are ongoing as concerns were raised early on regarding the close ties between the Billy Dunn, director of FDA’s office of neuroscience, and Biogen execs. Dunn’s deputy Eric Bastings also recently departed the FDA for a role as VP of development strategy at Ionis Pharmaceuticals, a company with close ties to Biogen.
The FDA is conducting its own internal investigation and another is being conducted by the US House committees on oversight and energy & commerce. The congressional investigation launched in July, as representatives sought from the company a variety of different internal and external documents and communications relating to assessments of Aduhelm’s safety, efficacy, and clinical benefit.
House committees kick off investigation into how Biogen's Aduhelm won approval
At the request of acting FDA commissioner Janet Woodcock, the Office of Inspector General of HHS also is investigating Aduhelm and the accelerated approval pathway in general.
Findings from the HHS investigation aren’t expected until next year, and the timelines on the other investigations have yet to be announced.