The US House Committees on Oversight and Reform & Energy and Commerce Thursday jointly released a report criticizing the US Food and Drug Administration’s (FDA) approval of Alzheimer’s drug Aduhelm. The report says that the FDA and Aduhelm-manufacturer Biogen acted in concert to get the drug approved in a hastened manner despite doubts about Aduhelm’s efficacy and failed clinical trials.

The committees described the approval process as “rife with irregularities” and concluded:

The criticism surrounding Aduhelm’s approval may have been avoided had FDA adhered to its own guidance and internal practices. FDA must take swift action to ensure that its processes for reviewing future Alzheimer’s disease treatments do not lead to the same doubts about the integrity of FDA’s review. Biogen, which currently has another Alzheimer’s drug under review by FDA, must provide more transparency into its pricing and analyses of clinical benefit to ensure that new drugs are effective and available for those who need them.

The 18-month investigation also addressed the $56,000-a-year price of Aduhelm.

Both entities conducted several meetings concerning the drug’s clinical trials, some without the proper logs required by FDA protocols. The report says this irregular “collaborative workstream” began in July 2019 to discuss options following a failed drug trial.

Biogen stated that it “stands by the integrity of the actions taken” and “will continue to appropriately engage diverse stakeholders at every step, including patients and their families, health care providers, and the scientific community.”