The 8 major points from the article are:
- 1. FDA officials failed to document communications with Biogen
2. Internal clashes caused last-minute chaos at the FDA
3. Collaboration between the FDA and Biogen was ‘atypical’
4. Biogen was banking on a blockbuster
5. The company was ‘pushing the limit’ on price
6. Biogen knew Aduhelm would be a budget-breaker
7. The FDA proposed allowing Aduhelm for all Alzheimer’s patients
8. Biogen aimed to target communities of color with marketing, not clinical data
The High Price of Aduhelm’s Approval: An Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans
From the conclusions paragraph
Recommendations from the congressional report: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. The findings
also justify experts’ and stakeholders’ concerns about FDA’s accelerated approval of Aduhelm.
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.221 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
- 1. FDA Must Fully Implement Its Own Internal Review Recommendation and Ensure All Substantive Interactions with Drug Sponsors Are Properly Memorialized
2. FDA Should Follow Through on Its Internal Review Recommendation and Establish a Protocol for Joint FDA-Drug Sponsor Briefing Documents for Advisory Committees.
3. FDA Should Provide Updated Guidance for Industry Regarding Development and Review of New Alzheimer’s Drugs.
4. Biogen and Other Drug Sponsors Should Communicate Safety and Efficacy Concerns to FDA
5. Biogen and Other Drug Sponsors Should Consider Value and Patient Access When Setting Prices.