The accelerated approval of a controversial drug used to treat Alzheimer’s disease has triggered US lawmakers to push for more oversight from the FDA
FDA commissioner Robert Califf has pledged to reform the agency’s accelerated drug-approval programme.Nearly a year after the US Food and Drug Administration gave the green light to a controversial, lawmakers are attempting to amend the process that led to its approval.
Aducanumab is not the only reason that this drug-approval pathway is coming under fire: since its inception, the programme has led to 279 treatments reaching the market, with nearly two-thirds in the past decade alone . The programme’s increasing popularity signals a shift away from its original intent, says Diana Zuckerman, president of the National Center for Health Research, a non-profit organization in Washington DC.
The pathway has turbocharged the number of immunotherapies and cancer treatments on the market. But some of these drugs cost hundreds of thousands of dollars per year, despite, in many cases, limited data showing their clinical utility. Gonsalves argues that the programme has been co-opted by the pharmaceutical industry to speed approvals. Cancer treatments approved through the pathway have made it to market on average about three years earlier than they would through standard routes.
Clinical trials on the Alzheimer’s treatment aducanumab are continuing after the drug’s fast-track approval.The FDA granted Biogen nine years to complete its confirmatory trial on aducanumab — a timeline that Alexander calls “frankly offensive”. Biogen has since said it will complete the trial in four years, and a spokesperson for the company says that data from the trial — not yet published or peer-reviewed — show a slowing in clinical decline for some people who are taking the drug.
Jeremy Kahn, a spokesperson for the FDA affirmed in an email that the agency is committed to ensuring the integrity of the accelerated-approval programme and noted that the agency believes people who lack treatment options for serious diseases are willing to"accept some uncertainty" in clinical benefit for new treatments. Clinical benefit has been verified in the vast majority of accelerated approvals, he added.
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