- Having already come under scrutiny from the U.S. government, Biogen's recently approved treatment for Alzheimer's disease is now also on the radar of two more federal agencies that want information about how the drug gained approval and how it's been marketed since.
- In a regulatory filing Thursday, Biogen said the Federal Trade Commission had sent a type of subpoena known as a "civil investigative demand," looking for more details about the drug, called Aduhelm. The company said it has also received an inquiry related to Aduhelm from the Securities and Exchange Commission.
- These requests affirm that federal regulators remain intently focused on Biogen's drug and the unusual circumstances surrounding its approval. Shortly after it was cleared for market last June, two committees in the House of Representatives launched a joint investigation to examine Aduhelm's approval and pricing. The U.S. health department's inspector general is also looking into the process that the Food and Drug Administration used to approve Aduhelm.
Aduhelm's approval was historic — providing, for the first time in the U.S., a medicine meant to treat the root cause of Alzheimer's, rather than just symptoms of the disease. But it was also highly controversial. The clinical trial data backing Aduhelm were mixed and complicated. Biogen and the FDA also maintained an unusually close relationship while study results were being analyzed and submitted for review.
The pushback against Aduhelm grew stronger when, shortly after receiving approval, Biogen revealed an initial list price of $56,000 for the average patient eligible to receive its drug.
This price, along with the way FDA staff handled Aduhelm's review, triggered the investigations from the health department's inspector general and the House Committees on Oversight and Reform and Energy and Commerce. Now, with the FTC and SEC knocking on Biogen's door, it would appear that regulatory interest in the drug is growing.
In its annual report, Biogen specified that the agencies are seeking information about Aduhelm's approval, as well as the ways in which the drug has been marketed and the sites that have been administering it.
Ahead of Aduhelm's approval, Biogen and its development partner Eisai had earmarked $600 million to spend on commercialization activities. The companies also identified at least 900 treatment sites they're hoping will use Aduhelm.
So far, though, that work and investment hasn't translated to big sales. Biogen recorded $3 million worth of Aduhelm sales last year, which was a small fraction of what analysts had forecasted following the drug's approval. And only a fraction of the sites identified by the companies have agreed to administer the drug.
Biogen and others expect that, for Aduhelm to rebound, it would need favorable coverage from Medicare, the government insurance program for people aged 65 and older. But some investors have serious doubts about whether that will happen, especially after last month, when Medicare proposed a policy that would strictly limit which patients would be eligible to receive Aduhelm or other Alzheimer's drugs that work like it.
Biogen is now campaigning to change Medicare's position before a finalized version of the policy comes in April.