FDA criticized for working too closely with biotech company to approve Alzheimer’s drug

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• Judy Woodruff:

  New findings from a congressional investigation into the Food and Drug Administration and the biotech company Biogen find that the FDA broke its own protocols to approve a new Alzheimer's drug last year.

  The findings conclude that the regulator worked too closely with Biogen, despite significant concerns over the limited benefits and side effects of the new drug Aduhelm.

  Geoff Bennett has that.

• Geoff Bennett:

  Judy, when the FDA approved the drug back in June of 2021, Biogen had hoped to earn billions of dollars off of it within a few years.

  But the congressional report found numerous problems in the lead-up to that approval, including, the FDA's interactions with Biogen were — quote — "atypical" and included collaboration in at least 115 meetings, calls and e-mails about the drug.

  The FDA approved Aduhelm for Alzheimer's patients, despite the lack of clinical trial data and concerns among FDA advisers. And Biogen set an unjustifiably high price of $56,000 a year for patients in order to — quote — "make history."

  STAT has worked on its own investigations into all of this. And reporter Damian Garde joins us now.

  It's great to have you here.

  Damian, this report is the result of an 18-month investigation by two House committees. Investigators reviewed some 500,000 documents from the FDA and from Biogen. And investigators concluded that the FDA went way beyond its normal protocol bringing this drug to market.

  Tell us more about that. In what ways?

• Damian Garde, STAT News:

  Yes.

  So, I mean, as they concluded the process was — quote — "rife with irregularities." And what it really boils down to is, in the normal process by which drugs are approved, the FDA is a neutral regulator, somewhat of an oppositional relationship they might have with the drug company seeking approval. They're meant to vet the data very seriously, very earnestly, such that a person or a doctor prescribing a drug can be certain that its benefits and risks have been thoroughly examined by an independent body.

  In this case, what we learned — or what we had reported previously, but really learned in detail with this investigation, is that the FDA worked more like a collaborator, as you said, worked hand in glove with Biogen on preparing the materials that would go before those independent advisers and on, furthermore, working behind the scenes to find a way to approve this medicine, over the concerns that basically the entire neurological community had voiced at that point.

• Geoff Bennett:

  Well, let's talk about the price, because Aduhelm has an annual price tag of $56,000, which Biogen executives previously called fair and responsible.

  How did they arrive at that price?

• Damian Garde:

  That's what's fascinating.

  We have heard so much backlash to drug pricing and the rising cost of new medicines in recent years, and we have heard every conceivable defense for those prices from drug companies. Thanks to this investigation, we got an inside look at how the company actually came up with it.

  And what we learned basically is that they surveyed insurance companies and neurologists to test a range of prices and see how people felt about them. They concluded that charging about $20,000 or $15,000 a year would be the way to maximize the most number of patients who could have access to this drug. Anything over $40,000 a year was definitely going to run into pushback and backlash from physicians and payers.

  Biogen chose, as we know, $56,000 a year, in the name of what they described in internal documents as revenue maximization and, as you mentioned before, this goal to make history with what would have been, by their calculations, the largest pharmaceutical product in history.

• Geoff Bennett:

  The report also delves into the FDA's initial decision to approve Aduhelm for Alzheimer's patients across the board, even though it was really indicated for people in mild, early stages of the disease.

  Tell us more about that.

• Damian Garde:

  That part is especially fascinating, because what we learn from the internal documents is that even Biogen was shocked that the FDA was considering and ultimately decided to approve it for all six million Americans with Alzheimer's disease, rather than, as you mentioned, the subset in whom the drug had been studied.

  What's interesting is, Biogen didn't push back against that, which the congressional committees kind of knocked them for. But the mystery remains, why did the FDA do this? We have seen a lot of these internal documents. We have seen their justification for it. But it's unclear why the agency, knowing how controversial this drug was at the time, would choose to approve it for such a large number of people.

• Geoff Bennett:

  So, in response to all of this, Biogen has refuted the report's implication, saying it stands "by the integrity of the actions we have taken."

  The FDA previously determined in its own review that officials acted appropriately, but said it started implementing the report's recommendations.

  The FDA, as you well know, is now evaluating two other Alzheimer's drugs for possible approval early next year. What are the implications of this report on that process?

• Damian Garde:

  Yes, it's fascinating timing.

  As you mentioned, any day now, probably next week, we're going to learn that another Alzheimer's treatment, a different one with less baggage, I would say, attached to it will likely win FDA approval. That process is technically separate from the one that happened with Aduhelm.

  But the timing is uncomfortable. I think, for the FDA. The entire world has just seen this book-length rebuke of the process by which they approved the last Alzheimer's drug, and in approving a new one, the process of rebuilding that reputation, I guess, really begins now, to neurologists, to patients, really to everyone in this community.

  They want to trust that FDA approval means that the risks and benefits are well understood and that the label reflects the evidence behind a given treatment. But, I mean, there's no guarantee exactly that the next approvals are going to be received as they would have been if not for this entire Aduhelm debacle.

• Geoff Bennett:

  Damian Garde, thanks so much for your time and for your insights.

  Appreciate it.

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