✦ The HHS Office of Inspector General on Aug. 4 revealed that it will investigate the how the FDA implements its accelerated approval pathway in the wake of the agency approving the controversial Alzheimer’s drug Aduhelm (aducanumab). FDA Acting Commissioner Janet Woodcock, M.D. — who was not involved in the decision to approve Aduhelm — had asked the OIG to investigate the approval process for the drug, citing concerns raised about “contacts between representatives from Biogen and FDA during the review process.” In its announcement, the OIG said it will review “interactions between the FDA and outside parties as well as other aspects of the [accelerated approval] process, such as deciding on this pathway and scientific disputes,” and that it will make recommendations based on a sample of drugs using the pathway, including Aduhelm.
✦ A new lawsuit filed by Kaiser Foundation Health Plan accuses drugmaker Merck & Co. of conspiring with Indian pharmaceutical manufacturer Glenmark Pharmaceuticals in a “pay-for-delay” scheme to prevent generic versions of cholesterol medications Vytorin and Zetia from entering the market, Modern Healthcare reported. The lawsuit, filed in the U.S. District Court of Northern California on July 16, alleges that the drugmakers reached a “quid pro quo” agreement in which Glenmark agreed to drop a patent challenge against Merck and Merck promised not to launch a generic competitor during Glenmark’s 180-day drug exclusivity period — resulting in Kaiser overpaying by “hundreds of millions” of dollars for the drugs. The suit accuses Merck of breaking antitrust laws in California, Washington D.C., Hawaii and Oregon.
✦ Nearly 1.5 million Medicare Part D enrollees had out-of-pocket spending above the catastrophic coverage threshold in 2019, which means they are required to pay 5% of their total drug costs unless they qualify for low-income subsidies. That’s one takeaway from a recent issue brief from the Kaiser Family Foundation, which also found that the number of Part D enrollees with out-of-pocket drug spending above the catastrophic threshold in a given year has more than tripled between 2010 and 2019, and has been at or above 1 million each year since 2015. In addition, more than 1.4 million Part D enrollees had out-of-pocket spending above the catastrophic threshold in two or more years during the five-year period between 2015 and 2019, and nearly 2 million enrollees had spending above the catastrophic threshold in two or more years over a 10-year period.