Legislation
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.
There are increased complexities associated with potential regulatory divergence between the UK and the EU when the Medicines and Healthcare products Regulatory Agency takes over responsibility for UK-wide new drug approvals from January 2025, writes the ABPI's Rick Greville.
John Murphy, who will take over the Association for Accessible Medicines in October, said in an interview that the number and types of voices advocating for the generics industry must increase.
Senate HELP Committee chair Sanders is trying to broker a deal between Novo Nordisk and the major pharmacy benefit managers that will lead to lower list prices for Ozempic and Wegovy. Prominent Republican raises international reference pricing.
As amended, the Give Kids A Chance Act would renew the rare pediatric disease voucher program for five years and give the FDA new authority to bring enforcement action when pediatric studies are overdue. However, it would not remove the exemption from pediatric study requirements for non-cancer orphan drugs, which Democrats had sought.
The new European Commissioners will face a grilling from members of the European Parliament before they can be confirmed in their posts.
The Pharmacy Benefit Management sector remains nearly universally unpopular with both Democratic and Republican lawmakers in the US. But a September 11 hearing stands out as an event where at least the witnesses suggested that there is value in the PBM business model.
The new US Medicare drug price negotiation authority got a brief mention during the 10 September presidential debate, not that anyone is likely to be talking about it afterwards.
With the BIOSECURE Act halfway to congressional approval, stakeholders are pushing for a financial boost to ensure the US gains the business Chinese companies will lose, but that may be a big lift.
The European Commission has registered a European citizens' initiative that explains how the EU can foster equitable, timely, affordable, safe and legal access to innovative psychedelic-assisted treatments. Work towards securing the one million signatures needed for the next step is starting soon.
If the US Congress continues to target trials at Chinese military hospitals, the impact could be relatively small, while a broader focus could upend multinational development programs.
Under current law, drugs or biologics must receive rare pediatric disease designation before 1 October to be eligible for a priority review voucher. The sunset provisions caused a spike in designation requests and a push by pediatric and rare disease advocates for an extension.