The Department of Health and Human Services\u0026#039; internal watchdog must launch a formal probe following a new exposé showing Biogen \u0022courting\u0022 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.\r\n\r\n\u0022The circumstances described in the STAT exposé, if confirmed,\u0022 said Dr. Michael Carome, director of Public Citizen\u0026#039;s Health Research Group, \u0022paint 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.\u0022\r\n\r\nCarome\u0026#039;s call for an inspector general probe, as well as a renewed demand for the removal of three leading officials responsible for the FDA\u0026#039;s aducanumab approval earlier this month—acting FDA Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni, and CDER\u0026#039;s Office of Neuroscience (ON) director Billy Dunn, who\u0026#039;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).\r\n\r\nThe 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 \u0022was probably the worst drug approval decision in recent U.S. history.\u0022\r\n\r\nIn his letters, Carome cites a number of \u0022troubling revelations\u0022 from STAT\u0026#039;s reporting that show \u0022unprecedented and inappropriately close collaboration\u0022 between FDA officials and Biogen, which is marketing the drug under the brand name Aduhelm. One example is a May 2019 \u0022off the books\u0022 meeting between Biogen chief scientist Al Sandrock and Dunn, whom STAT described as the FDA\u0026#039;s \u0022top regulator of Alzheimer’s drugs,\u0022 because Sandrock \u0022wanted to know if Dunn would be open to helping find a way to get the drug approved.\u0022\r\n\r\n\u0022It was clear that Billy Dunn was an ally, so the job for Biogen became figuring out how to support his efforts within the FDA,\u0022 said a former Biogen employee who spoke with STAT.\r\n\r\nA month after that off-the-books meeting, officials in Dunn\u0026#039;s ON \u0022were so willing to advance Aduhelm that they proposed as one option a regulatory shortcut called \u0026#039;accelerated approval,\u0026#039;\u0022 the pathway it ultimately took.\r\n\r\nAccording to STAT,\r\n\r\n\r\nAll of the investment that Biogen put into courting Dunn appeared to be paying off. Dunn\u0026#039;s Office of Neuroscience offered Biogen a road map to Aduhelm\u0026#039;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\u0026#039;s immediate approval.\r\n\r\n\r\nIn a statement, Carome called FDA’s decision to approve aducanumab \u0022a disastrous blow to the agency’s credibility, public health, and the financial stability of the Medicare program,\u0022 given the drug\u0026#039;s high price tag and Medicare\u0026#039;s current prohibition from negotiating drug prices with manufacturers.\r\n\r\n“It is imperative that that HHS OIG and Congress thoroughly investigate this decision and the circumstances that preceded it,\u0022 he said, \u0022including the inappropriately close collaboration between the FDA and Biogen that corrupted FDA’s review and decision-making process for the drug.\u0022\r\n\r\nTwo separate House committees have already begun investigations into the approval and pricing of Biogen.\r\n\r\nIn 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 \u0022serious concerns about the steep price of Biogen\u0026#039;s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug\u0026#039;s clinical benefit.\u0022\r\n\r\n“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\u0026#039;s treatments and federal healthcare programs,\u0022 the lawmakers said.