Distribution/Supply Chain
Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.
The new act aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU. It should recognize differences between generics and innovative products, says industry group EUCOPE.
Lilly is broadening the range of single-use vial dosage forms of its obesity drug and lowering prices of existing doses for self-paying customers, but maintains it can handle increased demand as compounding ends.
Eli Lilly's move is said to be part of broader industry campaign to invest in America and avoid President Trump's tariffs, but the company also said tax reform is necessary to make the investments.
A declaratory order removing semaglutide from the FDA shortages list duplicates much of the language in a December decision still in litigation that declared Eli Lilly’s tirzepatide products Mounjaro and Zepbound were no longer in shortage.
President Trump’s 10% tariff on active pharmaceutical ingredients and finished dosage forms could push some generic drug makers to exit therapeutic categories if they cannot absorb the new costs, which could lead to shortages.
At a lively AAM Access! conference in Florida, AAM President and CEO John Murphy acknowledged the negative effects of potential tariffs, but also suggested that the second Trump Administration could be an opportunity for the generics and biosimilars sectors to advance market reforms.
Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.
European regulators should develop a harmonized medicines shortages prevention and mitigation system and look to target the root causes of shortages, says pharmaceutical industry federation EFPIA.
The UK’s “world-first” tailored regulatory framework for point of care manufacturing is set to enter into force this summer.
Canada’s health products regulator is inviting feedback on a range of new and revised guidelines and regulatory tools that explain how drug and device companies will be able to comply with significant changes proposed to its shortages framework.
Compounding pharmacies have 60 days, and outsourcing facilities 90 days, to transition patients to branded products.
Efforts to de-risk the pharma supply chain’s reliance on China likely will not completely disappear if the BIOSECURE proposal dies.
Marketing authorization holders are being encouraged to insert their data on shortages of centrally authorized medicines in the new platform before it becomes mandatory to do so in February 2025.
Drug companies are being invited to participate in a new pilot project that the five Nordic countries will run to see if they can improve the availability of certain critical products that are used in hospitals.
More than 90% of companies have submitted new medicines packaging artwork to the UK’s drug regulator, the MHRA. The agency urges the remaining marketing authorization holders of its 31 December deadline to comply with the new Windsor Framework arrangements.
Throckmorton is known for enhancing the FDA’s drug shortage work by building bridges between the compliance and quality teams, as well as opioid oversight.
The Therapeutic Goods Administration says it wants to balance regulatory burden on sponsors with the need to improve its monitoring of medicine shortages.
With a looming deadline of 1 January 2025 for firms supplying Northern Ireland to comply with the Windsor Framework, UK generics and biosimilars association the BGMA has warned of potential supply interruptions due to requirements that include a “UK only” label for all packs as well as UK-based batch testing for biologicals.
As Sandoz publishes a report on US drug shortages, including a call for policy and other improvements, the firm’s North America head and AAM Chair Keren Haruvi discussed potential solutions to ongoing supply-chain failures.