Legislation
Republican presidential candidate Donald Trump says he will let Robert F. Kennedy Jr. “go wild on medicines” if he wins the White House. That could spell challenges for the US FDA in 2025.
Judges on the Third Circuit panel in the BMS and JNJ IRA cases seemed sympathetic to industry’s concerns about the government using the term “maximum fair price” in the IRA’s Medicare drug price negotiation program.
Some of the industry’s biggest challenges, and potential solutions, were hot topics at the BioFuture conference in New York.
Woodcock and the Haystack Project want to modify a foundational concept of modern FDA drug efficacy assessments, which may be seen as an attempt to more formally codify and define regulatory flexibility.
Olivér Várhelyi’s plans for his new role boil down to continuing legislative projects and other initiatives that have already been set in motion.
The second of six implementing acts for the Health Technology Assessment Regulation has now been adopted. It deals with how the European Medicines Agency is to cooperate with the European Commission and HTA experts in Europe.
Drug discount program reform would have the best chance of enactment if Republicans gain control of both the House and Senate and former president Trump is re-elected.
The updated directive could risk the supply of critical medicines and fail to incentivize greener product development more generally, warns European industry group EFPIA.
Whether the legislation aimed at discouraging use of Chinese contractors passes in its current form or not, industry will continue to face more pressure to decouple its operations.
The outcome of the November presidential election may impact whether the government is willing to defend FDA's relaxation of the mifepristone REMS. The case poses risks for the broader drug approval process.
New updates to 2006 regulations expand the existing framework governing drug shortages in Belgium.
The 2025 social security financing bill includes measures to reduce spending on reimbursed drug costs, change the way that industry paybacks are calculated, and tackle medicine shortages.
But the prospects for attaching the legislation to a federal spending package in December will be dependent on the outcome of the upcoming elections.
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.
Instead of $5bn in 2025, the redesign could cost the federal government two to four times that amount, the Congressional Budget Office told Republican lawmakers. And the Part D premium stabilization demonstration will cost an additional $7bn, the office projected.
The French pharma industry body Leem says that the scale of its contribution to health insurance cost savings is undermining the industry’s financial sustainability.
An agreement to extend government funding until 20 December means no shutdown for the US FDA or other agencies, but also that a busy December awaits for biopharma lobbyists.
High unmet needs is among the terms and definitions in the EU’s regulatory reform package that are “very subjective” and require more clarity to improve predictability for the pharmaceutical industry, EUCOPE’s secretary general, Alexander Natz, tells the Pink Sheet.
With BIOSECURE's legislative progress on pause until after the election, a Pink Sheet infographic looks back on the Capitol Hill progress to date and looks ahead to the potential impact if it is enacted, using Evaluate Pharma data to highlight the likely holes in pharma’s supply chain.