In this photo illustration the Biogen logo is seen on a smartphone with a Food and Drug Administration (FDA) logo in the background. (Photo: Pavlo Gonchar/SOPA Images/LightRocket via Getty Images)
Jun 30, 2021
The Department of Health and Human Services' internal watchdog must launch a formal probe following a new expose showing Biogen "courting" a key U.S. Food and Drug Administration official and an apparent lack of independence between the federal agency and the pharmaceutical company in the lead-up to the controversial approval of Alzheimer's disease drug aducanumab, Public Citizen said Wednesday.
"The circumstances described in the STAT expose, if confirmed," said Dr. Michael Carome, director of Public Citizen's Health Research Group, "paint a damning picture of drug regulators who surrendered their independence and objectivity, essentially began working on behalf of Biogen, and fostered regulatory capture at the agency."
Carome's call for an inspector general probe, as well as a renewed demand for the removal of three leading officials responsible for the FDA's aducanumab approval earlier this month--acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni, and CDER's Office of Neuroscience (ON) director Billy Dunn, who's at the center of the allegations in the new STAT reporting out Tuesday--came in a pair of letters sent to Department of Health and Human Services (HHS) Secretary Xavier Becerra (pdf) and the HHS Office of Inspector General (OIG) (pdf).
The letters follow a crescendo of criticism over just why the FDA is letting a new drug with an annual $56,000 price tag hit the market over the recommendations of a independent panel of experts, the Peripheral and Central Nervous System Drugs Advisory Committee, who said there was insufficient evidence of its efficacy. Three panel members resigned in protest, including Dr. Aaron Kesselheim, a Harvard Medical School professor, who wrote in his resignation letter that it "was probably the worst drug approval decision in recent U.S. history."
In his letters, Carome cites a number of "troubling revelations" from STAT's reporting that show "unprecedented and inappropriately close collaboration" between FDA officials and Biogen, which is marketing the drug under the brand name Aduhelm. One example is a May 2019 "off the books" meeting between Biogen chief scientist Al Sandrock and Dunn, whom STAT described as the FDA's "top regulator of Alzheimer's drugs," because Sandrock "wanted to know if Dunn would be open to helping find a way to get the drug approved."
"It was clear that Billy Dunn was an ally, so the job for Biogen became figuring out how to support his efforts within the FDA," said a former Biogen employee who spoke with STAT.
A month after that off-the-books meeting, officials in Dunn's ON "were so willing to advance Aduhelm that they proposed as one option a regulatory shortcut called 'accelerated approval,'" the pathway it ultimately took.
According to STAT,
All of the investment that Biogen put into courting Dunn appeared to be paying off. Dunn's Office of Neuroscience offered Biogen a road map to Aduhelm's approval, suggesting five different scenarios or options for ways the drug could be reviewed by the agency to allow it to reach the market. Only one of those five option contemplated Biogen having to conduct another clinical trial before approval. Three would result in the drug's immediate approval.
In a statement, Carome called FDA's decision to approve aducanumab "a disastrous blow to the agency's credibility, public health, and the financial stability of the Medicare program," given the drug's high price tag and Medicare's current prohibition from negotiating drug prices with manufacturers.
"It is imperative that that HHS OIG and Congress thoroughly investigate this decision and the circumstances that preceded it," he said, "including the inappropriately close collaboration between the FDA and Biogen that corrupted FDA's review and decision-making process for the drug."
Two separate House committees have already begun investigations into the approval and pricing of Biogen.
In statement last week announcing the probes, Committee on Oversight and Reform chair Rep. Carolyn B. Maloney (D-N.Y.) and Committee on Energy and Commerce chair Rep. Frank Pallone, Jr. (D-N.Y.) expressed "serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefit."
"Our committees will be investigating this matter so Congress and the American people can better understand why this drug was approved, how Biogen set its price, and what impact this will have on research for future Alzheimer's treatments and federal healthcare programs," the lawmakers said.
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The Department of Health and Human Services' internal watchdog must launch a formal probe following a new expose showing Biogen "courting" a key U.S. Food and Drug Administration official and an apparent lack of independence between the federal agency and the pharmaceutical company in the lead-up to the controversial approval of Alzheimer's disease drug aducanumab, Public Citizen said Wednesday.
"The circumstances described in the STAT expose, if confirmed," said Dr. Michael Carome, director of Public Citizen's Health Research Group, "paint a damning picture of drug regulators who surrendered their independence and objectivity, essentially began working on behalf of Biogen, and fostered regulatory capture at the agency."
Carome's call for an inspector general probe, as well as a renewed demand for the removal of three leading officials responsible for the FDA's aducanumab approval earlier this month--acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni, and CDER's Office of Neuroscience (ON) director Billy Dunn, who's at the center of the allegations in the new STAT reporting out Tuesday--came in a pair of letters sent to Department of Health and Human Services (HHS) Secretary Xavier Becerra (pdf) and the HHS Office of Inspector General (OIG) (pdf).
The letters follow a crescendo of criticism over just why the FDA is letting a new drug with an annual $56,000 price tag hit the market over the recommendations of a independent panel of experts, the Peripheral and Central Nervous System Drugs Advisory Committee, who said there was insufficient evidence of its efficacy. Three panel members resigned in protest, including Dr. Aaron Kesselheim, a Harvard Medical School professor, who wrote in his resignation letter that it "was probably the worst drug approval decision in recent U.S. history."
In his letters, Carome cites a number of "troubling revelations" from STAT's reporting that show "unprecedented and inappropriately close collaboration" between FDA officials and Biogen, which is marketing the drug under the brand name Aduhelm. One example is a May 2019 "off the books" meeting between Biogen chief scientist Al Sandrock and Dunn, whom STAT described as the FDA's "top regulator of Alzheimer's drugs," because Sandrock "wanted to know if Dunn would be open to helping find a way to get the drug approved."
"It was clear that Billy Dunn was an ally, so the job for Biogen became figuring out how to support his efforts within the FDA," said a former Biogen employee who spoke with STAT.
A month after that off-the-books meeting, officials in Dunn's ON "were so willing to advance Aduhelm that they proposed as one option a regulatory shortcut called 'accelerated approval,'" the pathway it ultimately took.
According to STAT,
All of the investment that Biogen put into courting Dunn appeared to be paying off. Dunn's Office of Neuroscience offered Biogen a road map to Aduhelm's approval, suggesting five different scenarios or options for ways the drug could be reviewed by the agency to allow it to reach the market. Only one of those five option contemplated Biogen having to conduct another clinical trial before approval. Three would result in the drug's immediate approval.
In a statement, Carome called FDA's decision to approve aducanumab "a disastrous blow to the agency's credibility, public health, and the financial stability of the Medicare program," given the drug's high price tag and Medicare's current prohibition from negotiating drug prices with manufacturers.
"It is imperative that that HHS OIG and Congress thoroughly investigate this decision and the circumstances that preceded it," he said, "including the inappropriately close collaboration between the FDA and Biogen that corrupted FDA's review and decision-making process for the drug."
Two separate House committees have already begun investigations into the approval and pricing of Biogen.
In statement last week announcing the probes, Committee on Oversight and Reform chair Rep. Carolyn B. Maloney (D-N.Y.) and Committee on Energy and Commerce chair Rep. Frank Pallone, Jr. (D-N.Y.) expressed "serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefit."
"Our committees will be investigating this matter so Congress and the American people can better understand why this drug was approved, how Biogen set its price, and what impact this will have on research for future Alzheimer's treatments and federal healthcare programs," the lawmakers said.
The Department of Health and Human Services' internal watchdog must launch a formal probe following a new expose showing Biogen "courting" a key U.S. Food and Drug Administration official and an apparent lack of independence between the federal agency and the pharmaceutical company in the lead-up to the controversial approval of Alzheimer's disease drug aducanumab, Public Citizen said Wednesday.
"The circumstances described in the STAT expose, if confirmed," said Dr. Michael Carome, director of Public Citizen's Health Research Group, "paint a damning picture of drug regulators who surrendered their independence and objectivity, essentially began working on behalf of Biogen, and fostered regulatory capture at the agency."
Carome's call for an inspector general probe, as well as a renewed demand for the removal of three leading officials responsible for the FDA's aducanumab approval earlier this month--acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni, and CDER's Office of Neuroscience (ON) director Billy Dunn, who's at the center of the allegations in the new STAT reporting out Tuesday--came in a pair of letters sent to Department of Health and Human Services (HHS) Secretary Xavier Becerra (pdf) and the HHS Office of Inspector General (OIG) (pdf).
The letters follow a crescendo of criticism over just why the FDA is letting a new drug with an annual $56,000 price tag hit the market over the recommendations of a independent panel of experts, the Peripheral and Central Nervous System Drugs Advisory Committee, who said there was insufficient evidence of its efficacy. Three panel members resigned in protest, including Dr. Aaron Kesselheim, a Harvard Medical School professor, who wrote in his resignation letter that it "was probably the worst drug approval decision in recent U.S. history."
In his letters, Carome cites a number of "troubling revelations" from STAT's reporting that show "unprecedented and inappropriately close collaboration" between FDA officials and Biogen, which is marketing the drug under the brand name Aduhelm. One example is a May 2019 "off the books" meeting between Biogen chief scientist Al Sandrock and Dunn, whom STAT described as the FDA's "top regulator of Alzheimer's drugs," because Sandrock "wanted to know if Dunn would be open to helping find a way to get the drug approved."
"It was clear that Billy Dunn was an ally, so the job for Biogen became figuring out how to support his efforts within the FDA," said a former Biogen employee who spoke with STAT.
A month after that off-the-books meeting, officials in Dunn's ON "were so willing to advance Aduhelm that they proposed as one option a regulatory shortcut called 'accelerated approval,'" the pathway it ultimately took.
According to STAT,
All of the investment that Biogen put into courting Dunn appeared to be paying off. Dunn's Office of Neuroscience offered Biogen a road map to Aduhelm's approval, suggesting five different scenarios or options for ways the drug could be reviewed by the agency to allow it to reach the market. Only one of those five option contemplated Biogen having to conduct another clinical trial before approval. Three would result in the drug's immediate approval.
In a statement, Carome called FDA's decision to approve aducanumab "a disastrous blow to the agency's credibility, public health, and the financial stability of the Medicare program," given the drug's high price tag and Medicare's current prohibition from negotiating drug prices with manufacturers.
"It is imperative that that HHS OIG and Congress thoroughly investigate this decision and the circumstances that preceded it," he said, "including the inappropriately close collaboration between the FDA and Biogen that corrupted FDA's review and decision-making process for the drug."
Two separate House committees have already begun investigations into the approval and pricing of Biogen.
In statement last week announcing the probes, Committee on Oversight and Reform chair Rep. Carolyn B. Maloney (D-N.Y.) and Committee on Energy and Commerce chair Rep. Frank Pallone, Jr. (D-N.Y.) expressed "serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefit."
"Our committees will be investigating this matter so Congress and the American people can better understand why this drug was approved, how Biogen set its price, and what impact this will have on research for future Alzheimer's treatments and federal healthcare programs," the lawmakers said.
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