As per US News, Thursday’s Congressional report asserts that the FDA approval process for the controversial Alzheimer’s treatment Aduhelm was “riddled with errors” despite remaining reservations about the drug’s ability to halt the progression of the disease.
The report concludes that the agency’s actions with Biogen, the manufacturer of Aduhelm, “raise severe concerns about FDA protocol violations.” However, the 18-month inquiry conducted by two congressional committees also criticized Biogen for pricing the medicine too high.
Biogen managers opted on an annual cost of $56,000 for Aduhelm because the company sought to “position Aduhelm as one of the most successful pharmaceutical launches of all time,” while knowing the high price would burden Medicare and patients.
In addition, Biogen intended to spend up to several billion dollars on an extensive marketing campaign aimed at doctors, patients, advocacy groups, insurers, lawmakers, and communities of color, who were grossly underrepresented in the company’s scientific studies of the medicine.
The dispute surrounding Aduhelm (aducanumab) dates back to its clearance in June 2021. Following the drug’s clearance, the Cleveland Clinic and the U.S. Department of Veterans Affairs, among others, decided not to administer Aduhelm infusions because to its uncertain efficacy and dangers of brain swelling and hemorrhage.
The New York Times reported that once Medicare severely restricted its coverage of Aduhelm, which remained expensive even after its annual price was cut in half to $28,800, the drug was effectively removed off the market.
What made the FDA’s clearance process for Aduhelm so peculiar?
According to the report, an unusual arrangement referred to as a “collaborative workstream” began in July 2019, in which FDA officials met repeatedly with Biogen to analyze data from one failed trial and another that appeared to be somewhat successful, advising the company on whether to seek approval for the drug.
During the course of one year, there were at least 52 meetings, but not all were properly documented in accordance with FDA regulations, according to the report. In addition, “there was no formal documentation of at least 66 phone calls or meaningful email exchanges,” according to the report.
According to the Times, the FDA is currently studying two more Alzheimer’s treatments for possible approval by early next year, including one that Biogen helped develop. In light of this, the study emphasized that the agency “must take urgent action to guarantee that its processes for examining future Alzheimer’s disease medicines do not rise to the same suspicions about FDA’s review integrity.”
The Times said that in response, the FDA stated, “We fully cooperated with the committees’ examination and continue to study their findings and recommendations.”
However, it emphasized that the agency must contact often with corporations during the approval process. The statement continued, “We will continue to do so since it is in the greatest interest of patients.” However, the agency has already begun adopting adjustments in accordance with the recommendations of the committees. In the meanwhile, Biogen defended their medicine following the publication of the findings.
“Biogen stands by the honesty of our conduct. According to the congressional investigation, an FDA examination concluded, “There is no evidence that these discussions with the sponsor before submission were anything other than appropriate.” The company stated in a statement. The Times noted that members of the investigative congressional committees had harsh words for both the FDA and Biogen.
Rep. Frank Pallone (D-N.J.), leader of the House Energy and Commerce Committee, stated in a statement that the research “details the unorthodox FDA review process and corporate greed that led FDA’s contentious decision to award Aduhelm fast approval.”
His committee collaborated with the House Committee on Oversight and Reform, chaired by Rep. Carolyn Maloney, to conduct the inquiry (D.-N.Y.). She stated in a statement that she hoped the study would serve as “a wake-up call for FDA to alter its methods and a call to action for my congressional colleagues to continue supervision of the pharmaceutical sector to ensure they do not prioritize profits before people.”