Pharmacy benefit managers (PBMs) are under the microscope again, this time for the price markups their affiliated specialty pharmacies charge for generic drugs used to treat cancer, HIV, multiple sclerosis and other serious conditions.
It was in with the new and out with the old Jan. 3 as the gavel came down on the first session of the 119th U.S. Congress. Although Republicans will control both the House and Senate for the next two years, their narrow majority could prove a challenge to passing some of President-elect Donald Trump’s agenda, including his proposal to cut the corporate tax rate to 15% for companies that manufacture their products in the U.S.
As 2025 gets underway, a new European Commission will start work on its new five-year mandate, with plans for multiple pieces of legislation that have implications for biotech and pharma – and the life sciences industry more broadly – due to be put forward.
The first round of the U.S.’ Medicare negotiations accounted for a lot of digital ink and headlines in 2024. Next year is sure to bring more of the same as Medicare is to announce up to 15 Part D drugs to be negotiated in the second round by Feb. 1, even as several constitutional challenges to the process continue in federal appeals courts across the country.
The end of the year will be the end of an era at the FDA, as Bob Temple shuts his door at CDER for the last time Dec. 31. After more than half a century at the FDA’s drug center, Temple has become the backbone of CDER’s new drug program, providing expertise and stability as other personnel have come and gone.
With no time to spare, the U.S. Congress is coming together on a continuing resolution (CR) to keep the federal government running beyond Dec. 20. Intended to fund the government at current levels through March 14, the CR itself is temporary. But of the 1,500-plus pages in the package House leadership released late Dec. 17, only about 100 pages pertain to the actual CR. More than a third of the package is devoted to the health-care sector.
If a bipartisan group of U.S. House members has its way, at least some of the legislation congressional committees have passed to target pharmacy benefit manager (PBM) practices could yet make it into law this year. That is if congressional leaders listen to the rank-and-file members.
The Biosecure Act missed its expected ride through the U.S. Congress via the National Defense Authorization Act, but it may not be the end of the road for the bill that would prohibit direct or indirect U.S. government contracts with listed “biotechnology companies of concern.”
With the U.S. Congress sitting on its hands on reforms to the 340B drug discount program, states are stepping into the gap. While most state efforts have been aimed at forcing biopharma companies to give the federally mandated drug discounts to an increasing number of contract pharmacies, California is looking in a different direction. According to unofficial election results, a slim majority of the state’s voters said yes to Proposition 34, which would require certain providers that benefit from the drug discounts to spend at least 98% of their 340B revenues on direct patient care.
The drug and device industries have a lot hinging on the results of the Nov. 5 U.S. presidential and congressional elections. Tax policies. The reach of the FTC. Legislation aimed at drug prices, competition, pharmacy benefit managers and lab-developed tests. Cabinet and agency appointments that could reshape Medicare drug negotiations, the 340B program, FDA Orange Book device patent listings, regulatory flexibility and Bayh-Dole march-ins. And that’s just the top of the list.
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