After languishing on the U.S. Senate floor for more than a year, the Affordable Prescriptions for Patients Act (S. 1041) finally got a unanimous vote July 21 and is now on its way to the House, again. Aimed at reining in patent thickets, the bill limits the number of patents a biologics sponsor can assert against a biosimilar when engaging in the voluntary “patent dance” laid out in the Biologics Price Competition and Innovation Act. The number is no more than 20 patents, a limit the bill’s bipartisan sponsors called “reasonable.”
In a rapid-fire voting session, the U.S. House suspended the rules July 20 to pass, by voice vote, a slate of bipartisan health bills ranging from reducing animal testing in drug development to clarifying Medicare coverage of wheelchairs.
Citing the significant advancements made in lab testing technologies since the Clinical Laboratory Improvement Amendments (CLIA) were enacted nearly 40 years ago, the U.S. CDC and Center for Medicare and Medicaid Services are considering updating the regulations to reflect today’s technology.
