News Briefs

EmployersRX, a coalition of organizations representing health care purchasers that aims to bring down drug costs, has joined the growing number of groups expressing concern about the cost of a recently approved novel Alzheimer’s disease drug. “The approval of Aducanumab despite its questionable effectiveness, and its unjustifiable price, demonstrate the profound need for substantial reforms to how the United States approves and prices prescription drugs,” wrote the group in a letter to congressional leaders dated June 21. The FDA approved Biogen, Inc.’s Aducanumab (aducanumab-avwa) earlier this month even though an independent advisory council advised against it, sparking outcry over concerns about its efficacy as well as its annual wholesale acquisition cost of $56,000.

In other Aducanumab-related news, The Wall Street Journal reported on June 22 that the FDA’s approval of the drug came despite objections from the agency’s drug statistics office, which argued that clinical trial data fell short of the proof typically required to put a new product on the market. The article, which cites “newly released internal memos,” reveals that the FDA ultimately decided to approve the drug in part because Alzheimer’s patients have “a serious, progressive, ultimately fatal disease and are desperate for treatments,” in the words of Peter Stein, director of the FDA’s office of new drugs.

© 2021 MMIT

AIS Health Staff

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