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Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling of its polarizing approval of a new Alzheimer’s drug. She was emphatic in her defense of the therapy and the agency’s approval decision in an interview at STAT’s Breakthrough Science Summit, but said “it’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved.” (Cohrs, 7/14)

In a striking reflection of concern over the approval of the controversial new Alzheimer’s drug Aduhelm, two major American health systems have decided that they will not administer it to patients. The Cleveland Clinic, one of the largest and most respected medical centers in the country, said in a statement that a panel of its experts had “reviewed all available scientific evidence on this medication,” which is also called aducanumab. (Belluck, 7/14)

At least half-a-dozen private health insurers in some of the nation’s largest states are balking at covering Biogen’s controversial drug for Alzheimer’s disease, saying it is an experimental and unproven treatment despite being approved by the federal government one month ago. Six affiliates of Blue Cross and Blue Shield in Florida, New York, Michigan, North Carolina, and Pennsylvania say in newly adopted policies they will not cover the Cambridge biotech’s drug, Aduhelm, because they consider it “investigational” or “experimental” or because “a clinical benefit has not been established.” Aduhelm, which is priced at $56,000 a year, is intended to slow cognitive decline in patients with early Alzheimer’s symptoms, regardless of their age. (Saltzman, 7/14)

The Food and Drug Administration last month foisted a nearly impossible decision on insurers: Should they pay for an expensive new Alzheimer’s drug that may not actually help patients? Normally, if a drug gets FDA approval, that means it has some benefit to patients. But the FDA decided to greenlight Biogen’s controversial drug Aduhelm without that guarantee. That decision leaves patients, clinicians, and insurance companies in the dark. (Cohrs, 7/15)

In an embarrassing rebuke, the Food and Drug Administration has scolded Amgen (AMGN) over a drug advertisement that made misleading claims and, as a result, might confuse physicians and thwart the use of lower-cost biosimilar versions. The agency noted that a banner ad for the Neulasta bone marrow stimulant cited a study claiming there is a statistically significant higher risk of developing febrile neutropenia — a life-threatening complication of cancer treatment — when using a pre-filled syringe than an injector placed on the patient’s body. Amgen markets the OnPro injector kit, which was the subject of the animated ad. (Silverman, 7/14)