On Wednesday, a federal court in Amarillo, Texas heard a case from Alliance Defending Freedom (ADF) that would potentially end legal access to mifepristone, one of two abortion pills in the United States. The lawsuit claims that the FDA acted illegally in approving mifepristone due to alleged harmful side effects and seeks retroactively to set aside that approval. The suit is presided over by Matthew Kacsmaryk, a former President Donald Trump nominee. In response the Women’s March held two protests, a morning “kangaroo court” and an evening street protest with activists wearing clown costumes. ,
The hearing brought attention to the issue of drug prices, as Novo Nordisk announced plans to reduce the list prices of several of its insulin products by up to 75 percent. This follows Eli Lilly slashing the prices of its insulin products and expanding a program to cap the out-of-pocket prices of $35 a month. The Danish company will also reduce the wholesale price of unbranded biologics in order to match its branded products. ,
Fourteen Democratic governors are asking seven of the nation's leading pharmacy retailers to clarify their plans for dispensing abortion pills after Walgreens announced that it won’t sell abortion pills or ship them in at least 20 states where Republican Attorneys General asked them not to. President Biden is scheduled to tout his administration’s efforts to reduce prescription drug costs at an event in Las Vegas. The White House has released the list of the first 27 drugs needed to pay Medicare back for hiking their medications faster than inflation price. Centers for Medicare and Medicaid Services will release details on how they plan to negotiate lower prescription drug prices for Medicare beneficiaries. ,
The FDA rejected the argument of the ADF, saying that the terms of Mifepristone’s use were replaced more than a decade ago by subsequent FDA programs created by Congress. Kacsmaryk questioned both sides on the U.S. Supreme Court cases that set out when extraordinary relief is allowed, while also considering how he could draft a preliminary injunction in the plaintiffs' favor. A decision from Kacsmaryk is expected soon, and if he rules against the FDA, it is unclear how quickly access to Mifepristone could be curtailed. ,
The ADF argued that the FDA misused its authority when it originally approved mifepristone and that the decision to allow abortion pills to be distributed by mail violates the 150-year-old Comstock Act, which prohibits mailing any drug used for “producing abortion”. At the hearing, the judge expressed skepticism about the government's process for approving mifepristone and questioned the safety of a more recent FDA decision allowing the medication to be dispensed by mail The Adderall shortage has not let up, with doctors warning of potential complications if pregnant women take the medication.