The nomination of Erica Schwartz as the next director of the U.S. CDC moved incrementally forward, gaining the support of a key Republican senator. Meanwhile, a delay in the scheduled committee vote July 23 to send her nomination to the Senate floor suggested she will need all the support she can get.
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.”
While the pace of executive orders (EOs) coming out of the White House continues to decline, the impact of new EOs on U.S. health agencies, life sciences industries and the practice of medicine remains just as disconcerting as a year ago.
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.
Two med-tech companies agreed to settlements with the U.S. government to resolve False Claims Act (FCA) allegations that they submitted Medicare claims for medically unnecessary testing and devices.
There have been plenty of complaints about U.S. Health and Human Services Secretary Robert Kennedy interfering with science. Now he’s facing allegations of a different kind of interference. Sen. Ron Wyden, D-Ore., the ranking member of the Senate Finance Committee, asked the U.S. Office of Special Counsel to immediately open an investigation into election interference claims against the secretary.
U.S. Health and Human Services Secretary Robert Kennedy was the 800-pound gorilla that couldn’t be ignored as the Senate Health, Education, Labor and Pensions Committee held a joint confirmation hearing July 15 for President Donald Trump’s nominees for CDC director and the head of the Administration for Strategic Preparedness and Response.
The U.S. Court of Appeals for the Seventh Circuit revived Teva Pharmaceuticals USA Inc.’s breach-of-contract suit against Eli Lilly and Co. July 13, as it chided the lower court for dismissing the complaint at the pleadings stage.
