The U.S. Food and Drug Administration (FDA) has been revered as the gold standard in pharmaceutical safety and efficacy review since the 1960s. More recently, partly in response to the HIV/AIDS epidemic and the pressing need for new treatments, the FDA established an accelerated approval process to hasten the review of new drug applications so that drugs could be approved and brought to market as soon as possible. Although accelerated approval has led to the availability of new treatments for patients with few other options, this Note argues that, today, the FDA grants accelerated approval too hastily and may be sacrificing scientific rigor in doing so.
On June 7, 2021, the FDA announced the accelerated approval of Aduhelm™ (aducanumab), sponsored by pharmaceutical manufacturer Biogen, for the treatment of Alzheimer’s disease. This approval occurred despite intense criticism of the drug’s efficacy from the scientific community and concerns about potentially dangerous side effects. Using Aduhelm as a case study, this Note illustrates the benefits and risks of the FDA’s accelerated approval process and proposes areas for improvement. It suggests revisions to the role of advisory committees that weigh in on whether a drug should be approved, offers ways to further incentivize pharmaceutical companies to confirm a new drug’s clinical benefits, and theorizes how a controversial drug approval from the FDA could be challenged in court.