Legislation
With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
US lawmakers will undoubtedly continue to work on pharmacy benefit manager reform legislation in 2025, given its bipartisan support. But policies impacting rebates that could lead to higher premiums in Part D may be a tough sell in the midst of the benefit redesign.
Neither Kamala Harris nor Donald Trump mentioned drug pricing reforms in their presidential convention speeches.
Congressional Budget Office responses to questions from US lawmakers on pharmacy benefit managers could add to the momentum for PBM reforms to go further than the current leading proposals.
Letter to US FDA by a bipartisan group of House members cites clinical trials sponsored by Eli Lilly and Pfizer as examples of a widespread industry practice. But any legislation to curtail such practices is not expected to be part of the BIOSECURE Act.
The agency is clearly on the radar of former President Trump and his new coterie of tech moguls.
A change in leadership of the US FDA device center is taking place with an eye towards stability in the longer term, but the upcoming elections could lead to more disruptive personnel changes.
Another House hearing again showcases the bipartisan desire to enact reforms to the US pharmacy benefit management sector. Legislators also sound ready to push for more significant actions than “transparency” measures would promise, but that means waiting until 2025.
The shake up in the US presidential campaign line up could have implications for future drug pricing policies. VP Kamala Harris has been an advocate for “march in” rights and could push that policy harder than incumbent President Joe Biden.
As the reauthorization deadline nears, CDER and CBER leaders stressed that sunsetting the program would hurt pediatric rare disease development, while endorsing a new Democrat-proposed stick for rare disease research.
The House Oversight Committee held its third hearing on pharmacy benefit manager reforms in 14 months, but could not elicit an admission from executives that they are responsible for increasing drug prices.
In this final article in a series on the ongoing amendments to the pharmaceutical reform package, the Pink Sheet looks at the tougher environmental risk assessment requirements that pharma companies are likely to face in the not-too-distant future.
A number of legislative proposals will be coming under scrutiny at the newly constituted European Parliament in the coming months, including the pharma reform package and draft legislation on EU-level compulsory licensing and “unitary” supplementary protection certificates.
A US House of Representatives bill to provide obesity drug coverage to a very select group of Medicare beneficiaries, passed only after Democrats debated whether the proposal is a “first step” towards broader coverage or a misstep counter to Medicare’s goals.
A Trump-aligned think tank doesn’t have too much to say about the US FDA – which is probably a good thing for the agency. But it does reinforce the reality that abortion politics will continue to impact the agency – and that ties to industry may be a bipartisan area of concern.
US federal agencies are entering a new era of uncertainty and increased litigation over their regulatory interpretations, but the FDA may benefit from the unique circumstances that have evolved through user fee legislation.
Clene leadership spoke with the Pink Sheet about its push for accelerated approval for its ALS nanoparticle treatment. A new nudge from Congress asking the US FDA to consider survival data in accelerated approval could help.
The House Appropriations Committee indicates in fiscal year 2025 appropriations report language that lawmakers will closely monitor the FDA’s implementation of clinical trial diversity action plans.
Two targeted treatments for six different types of cancer and two antifungal drugs are the first products that Pharmac has proposed should be funded after it received a boost to its budget in June. Separately, the government is seeking feedback on a bill to repeal the sweeping new therapeutic products law that was passed by its predecessor.