Two congressional committees recently released damning results of an 18-month investigation into the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, Aduhelm. The systems that enabled Biogen’s actions, however, went largely unscrutinized.
The report listed extensive and serious concerns about Aduhelm’s rollout, including “atypical” interactions and collaboration between the FDA and Biogen; inappropriate use of the FDA’s Accelerated Approval Program; initially approving the product for anyone with Alzheimer’s despite only testing it on patients in early and mild stages of the disease; and the company setting an “unjustifiably high price” for the drug. The report also noted that Biogen planned to spend billions of dollars on sales marketing for Aduhelm — more than twice its development costs for the product — with a specific strategy of targeting communities of color.
With each new story about problems in the pharmaceutical industry comes a chorus of complaints and calls for it to do better. The congressional report itself made its fifth and final recommendation that Biogen and other drug sponsors “should consider value and patient access when setting prices.”
While these calls are understandable, I believe they are misguided. There is no reason to expect a publicly held company like Biogen to act any differently than it did. In fact, it would be surprising if a shareholder-owned pharmaceutical company did not make every effort to maximize the profitability of its products. That is its statutory obligation.
It’s time to give up on pharmaceutical companies acting in the public interest over their shareholders’ interests and to start focusing on the systems that enable this behavior. As a starting point, here are four systemic changes that would have prevented Biogen from acting against the public interest.
First, while the House report rightly called on the FDA to take actions to improve its approval processes, it did not mention the broader systemic issue — the increasingly cozy relationship between the pharmaceutical industry and the FDA — that enabled these lapses to occur. With about 75% of the agency’s drug division now funded by the pharmaceutical industry via user fees, critics have repeatedly warned that such funding agreements enable weaker evidence to be used as evidence for drugs’ effectiveness. It has also made it more difficult to include provisions that would fast-track approval of generic drugs, as this cuts into large companies’ bottom lines. Despite these criticisms, Congress passed legislation in September 2022 to extend this funding model for another five years. It is unreasonable to expect the FDA to take a strict regulatory approach toward its paying customers.
Second, even modest drug-pricing negotiation regulations would have ensured that Biogen could not set an astronomical and irrational starting price. These regulations were repeatedly watered down in Congress’ most recent effort to adopt pricing negotiation in the Inflation Reduction Act, even though modest reductions would have saved the Centers for Medicare and Medicaid Services an estimated $102 billion over 10 years. Negotiating prices is all the more important for a product like Aduhelm, for which Medicare was estimated to account for more than 85% of the drug’s target patient population at the time of its launch. The Inflation Reduction Act also permits price negotiations for many years after approval, potentially incentivizing companies to charge more at the outset in order to have a better bargaining position once that period elapses.
Third, Biogen planned to heavily market to Black and Latino patients and their health care providers, even though clinical trials of the drug included only 3% Hispanic participants and 0.6% Black participants. Mandating better representation of marginalized communities in clinical trials could have minimized such disparities. Biogen eventually promised to increase diversity in its Phase 4 confirmatory trials, but only after it was required to do so by the Centers for Medicare and Medicaid Services.
Fourth, Biogen planned to heavily invest in funding patient groups. This is part of a broader pattern, in which patient groups have served as mouthpieces for the pharmaceutical industry in exchange for funding. This strategy is profitable for the pharmaceutical industry, because patient groups are generally presumed to speak for the public and are frequently called on by policymakers to testify on health issues. Although it is usually a terrific investment for the industry, it can make it difficult for the public to discern whether a patient group is speaking for the people it represents or echoing industry talking points. Even modest transparency requirements around corporate funding would vastly improve trust in patient groups, preventing companies like Biogen from influencing Alzheimer’s advocacy efforts.
As long as pharmaceutical companies are expected to do anything outside of maximizing profits, people will continue to be frustrated. Let’s stop expecting better from industry and start focusing on the systems that enable their practices. Any other strategy will continue to disappoint.
Daniel Eisenkraft Klein is a Ph.D. candidate at the University of Toronto’s Dalla Lana School of Public Health, studying pharmaceutical marketing strategies and funding of advocacy groups, and an expert consultant for the Opioid Industry Documents Archive, which is jointly hosted by the University of California, San Francisco, and Johns Hopkins University. The opinions expressed here are his own. He reports having received funds from a Social Sciences and Humanities Research Council Doctoral Fellowship, Defining Moments Canada, the University of Toronto, Johns Hopkins University, Ontario Western University, and Health Canada, though none of this funding conflicts with this work.
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