Congress Issues Report on FDA’s Aduhelm Approval

House committees are concerned with the atypical protocol that was followed.

Two House committees published a report at the end of the year highlighting the irregular means the Food and Drug Administration (FDA) used to approve Biogen’s Alzheimer’s drug Aduhelm. The report was the conclusion of an 18-month investigation conducted by the House Committee on Oversight and Reform and the House Committee on Energy and Commerce.

They found that the FDA’s review and approval of the drug were “rife with irregularities” and that the agency broke its own protocols. Among the findings were the overriding of the concerns of its panel of outside advisors as well as allowing the approval of Aduhelm based on limited evidence rather than thorough proof.

The report concluded, “The findings in this report raise serious concerns about FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm.”

As the Lord Leads, Pray with Us…

  • For members of the committees for oversight and commerce as they seek to hold the FDA accountable.
  • For FDA officials as they navigate the approval process for new medications.
  • For scientists and researchers as they determine the efficacy and safety of new pharmaceuticals.

Sources: Reuters, Healthcare Finance News


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