Speaker Nancy Pelosi’s, D-California, drug bill passes in the House; the FDA approves Vyondys 53, from Sarepta Therapeutics, to treat Duchenne muscular dystrophy; San Francisco tackles homelessness, mental illness, and substance abuse.
High drug costs are at the center of an ongoing debate in the House and Senate. However, on Thursday, the House voted 230-192 to pass Pelosi’s controversial drug pricing plan, HR 3, according to The Center for Biosimilars®, a sister site of The American Journal of Managed Care®. Included in the plan, known as the Elijah E. Cummings Lower Drug Costs Now Act, is a $2000 yearly medication spending cap for seniors and Medicare rebates from drug makers if their prices exceed inflation. With Republican lawmakers instead throwing their support behind HR 19, the Lower Costs, More Cures Act, HR 3 faces a likely veto from the White House should it pass the Senate floor.
Also on Thursday, the FDA changed its mind, approving Vyondys 53 (golodirsen), a drug to treat Duchenne muscular dystrophy (DMD), according to STAT. The medication, which is the second from developer Sarepta Therapeutics to treat DMD after Exondys 51 (eteplirsen), was previously rejected in August amid concerns of infusion port infections and kidney toxicity—adverse effects not mentioned in this approval. Exondys 51 costs more than $1 million per year, and Sarepta says Vyondys 53 will be priced at a similar level. The drugs treat rare mutations at exons 51 and 53, respectively, in the 13% and 8% of patients with DMD whose disease is caused by them.
A new controversial California state law, SB-1045, recently backed by San Francisco Mayor London Breed, aims to take on homelessness, mental illness, and substance use through expanded conservatorship, according to Kaiser Health News. The law gives the city permission to force the homeless, a majority of whom suffer from mental illness and substance abuse—and have visited emergency departments or been jailed multiple times in just 1 year—into treatment. But the ultimate aim is to provide them with a care coordination team and increase their awareness of the services available to help them. It was just in November that Breed and city supervisors Hillary Ronen and Matt Haney agreed on Mental Health SF, meant to reform the city’s mental health care system.