Legislation
The European Commission's 100-day countdown to deliver a Critical Medicines Act, aimed at improving the EU's resilience to supply chain disruptions and price volatility, began last December. Meanwhile, negotiations over the proposed package that will reform the over 20-year-old EU pharmaceutical legislation are now in the hands of the Council of the EU. The Pink Sheet examines what to expect for these key pieces of legislation this year.
The UK’s “world-first” tailored regulatory framework for point of care manufacturing is set to enter into force this summer.
Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.
EU joint clinicals assessments introduced under the HTA Regulation have now gone live for cancer medicines and advanced therapies.
Stakeholders have until 15 January to respond to a European Commission proposal that aims to harmonize pharmacovigilance activities by marketing authorization holders, national competent authorities and the European Medicines Agency.
Pharmaceutical industry says the transition from paper to electronic product information, as part of EU pharmaceutical reforms, should not be held back by member states' readiness.
6 January 2025 will be remembered in Washington, DC, as the date Congress certified Donald Trump’s second presidential election victory and a snowstorm shut down most of the city, but for FDA watchers it will be the day the agency released more than two dozen new draft and final guidances.
The agency’s actions may signal its optimism about near-term reauthorization despite the PRV program and other bills aimed at tackling rare and childhood diseases not making the December 2024 government spending bill.
Despite GOP criticism of the Part D stabilization program and its budgetary impact, the Trump Administration may decide to keep it in part to avoid blame for a premium increase.
The FDA will stay open, but its rare disease priority review voucher program will wind down after not being renewed on 20 December. PBM reform and other industry priorities also were nixed at the last minute in an effort to avoid a government shutdown.
President-elect Trump is backing a government funding bill that cuts pharma priorities, but it remains unclear whether the plan will garner enough votes to prevent a government shutdown.
A Catalyst fix, a pediatric rare disease voucher reauthorization that should prevent future workload imbalances for FDA, and a boost for out-of-state coverage in Medicaid are among Congress’s year end commitments to pediatric and rare disease patients that now seem in doubt.
As application of the Health Technology Assessment Regulation nears, the European Commission has launched two new websites to help developers kick start the joint clinical assessment process and request a joint scientific consultation.
Some pharma industry CEOs appear to have done well in their meeting with President-elect Donald Trump and his health care team.
Former Sen. Richard Burr suggested to the Pink Sheet that Trump’s HHS leadership picks will have less ability to enact their agendas than people expect.
A new congressional report on the public health response to the COVID-19 pandemic underscores that the FDA and its top managers may be in the hot seat.
The incoming Trump Administration’s “Department Of Government Efficiency” has big plans for sweeping cuts to the federal bureaucracy and regulation. The US FDA likely will feel some effects, but could avoid the most damaging mandates.
The European Commission’s proposed pharma legislation overhaul could expand the definition of a gene therapy medicinal product, posing challenges both from a regulatory and public perception perspective.
The pharma industry arguably suffered none of the possible downside risks during the first Trump Administration, but its relationship with Biden could not have been much worse. And while sponsors may hope a Trump return could improve their fortunes, having Robert F. Kennedy Jr. supervising the FDA is likely not the prescription they prefer.
The expected nominee for FDA commissioner has not been very kind to the agency in his public statements and President-elect Donald Trump appears to be urging him to shake things up.