�������ýҕ�l

The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug. Dr. Janet Woodcock announced the extraordinary step via Twitter. It’s the latest fallout over last month’s approval of Aduhelm, an expensive and unproven therapy that the agency OK’d against the advice of its own outside experts. (Perrone, 7/9)

In a letter to the Department of Health and Human Services’ independent Office of the Inspector General, the F.D.A.’s acting commissioner, Dr. Janet Woodcock, acknowledged the scrutiny the agency has faced about the approval process for the drug, which is known as Aduhelm and has a $56,000 annual price tag. She pointed to interactions between representatives from the drug’s developer, Biogen, and the agency, saying some “may have occurred outside of the formal correspondence process.” “To the extent these concerns could undermine the public’s confidence in F.D.A.’s decision, I believe it is critical that the events at issue be reviewed by an independent body,” Dr. Woodcock wrote. She noted that the review should look at whether any of the communication between the agency’s staff and Biogen’s representatives violated F.D.A. rules. (Robbins, 7/9)

The drug’s approval has been highly controversial, partly because of its annual price pegged at $56,000, and partly because evidence of the drug’s effectiveness was inconclusive. During the time when the agency was considering the drug, called Aduhelm, FDA reviewers met with the company, Biogen Inc., that makes the drug. They collaborated with the company to prepare a joint review document presented to an FDA panel of outside advisers at a public meeting in 2020. The watchdog group Public Citizen called in December for an inspector general investigation “to scrutinize the unprecedented close collaboration.” (Burton, 7/9)

Neurologist Matthew S. Schrag was surprised when he heard the Food and Drug Administration had approved a controversial Alzheimer’s drug. There was scant evidence the treatment worked, in his view. Even more concerning to Schrag: the FDA’s apparent embrace of a long-debated theory about Alzheimer’s disease, which afflicts more than 6 million Americans. The amyloid hypothesis, which has dominated the field for decades, holds that toxic clumps in the brain, called amyloid beta, are the main driver of the disease and that removing them will slow cognitive decline. (McGinley, 7/10)

Biogen Inc.’s new $56,000-a-year Alzheimer’s drug could wind up costing thousands of dollars more per patient than the company has said because of quirks in the way the therapy and others like it are packaged and paid for. Medicare and other insurers could wind up paying $61,000 to $62,000 a patient on average depending on the dosages each needs, according to an analysis published online Friday by the journal Health Affairs. (Walker, 7/9)