EU Critical Medicines Act Seeks to Enhance Supply and Access Requirements
The European Commission has proposed a new Critical Medicines Act aimed at reinforcing the security of supply and ensuring the availability of critical medicines and medicines of common interest across the EU. The Act introduces new obligations for pharmaceutical companies such as enhanced supply chain transparency, mandatory stockpiling, and regular reporting obligations. At the same time, it creates opportunities for investment and funding to expand EU-based manufacturing, diversify supply chains, and foster innovation. By shifting procurement practices to include award criteria beyond price considerations by prioritizing quality, supply security, and EU production, the Act aims to address vulnerabilities in the current supply system and reduce reliance on third countries. However, to avoid becoming another layer of red tape for industry, a final Critical Medicines Act must carefully balance new regulatory requirements with the need to maintain competitiveness and support a resilient, innovative pharmaceutical sector.
On-shoring Pharmaceutical Manufacturing: Navigating Regulatory Obligations and Strategic Considerations
The Trump administration’s Executive Order entitled, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” notes a desire to bolster supply chains, enhance national security, and ensure compliance with evolving regulatory frameworks. Nevertheless, the decision to relocate manufacturing operations for U.S. Food and Drug Administration (FDA)-approved drugs is fraught with regulatory obligations – including those administered by the FDA – and strategic considerations that must be thoroughly analyzed.
UK Life Sciences Sector Boosted By Raft Of New Policy Measures
A new policy document from the U.K. Government makes the life sciences sector a major focus for changes aimed at facilitating industrial growth. Marie Manley and Dr. Kwabena Tenkorang explain the relevant proposed changes, including reforms to speed up clinical trials, regulatory reforms, the introduction of low-friction procurement and the creation of a Health Data Research Service.
U.S. Executive Orders Shine Spotlight on India’s Life Sciences Industry
Three recent U.S. Executive Orders have significant consequences for India with its outsized role in global generic drug supply. The policy changes offer both opportunity and increased scrutiny for Indian drug manufacturers. Arif Noorani and Ryan Tan discuss proactive steps manufacturers can take.
UK Windsor Framework Enters Into Force
Recent UK regulatory developments of potential interest to international life sciences companies include: reforms aimed at speeding up medicines approvals and market access, global firsts with respect to certain orphan drug and cancer diagnostic approvals, and updates on unified packaging and labeling across the UK. Article authored by Dr. Chris Boyle and Dr. Kwabena Tenkorang.
The Union of AI and Drug Discovery and Development Requires New Thinking for Structuring and Negotiating Strategic Transactions, and a Rigorous Analysis of Applicable Regulatory Considerations
The use of artificial intelligence and machine learning (AI/ML) in drug discovery and development is well established and here to stay. With AI tools developing the potential to impact virtually every stage of the life sciences product life cycle, the FDA continues to refine its framework for the use of AI to support regulatory decision-making. On April 7, the FDA ended its consultation period on two draft guidance documents, one containing recommendations on the use of AI to support FDA regulatory decision-making and another providing a “comprehensive approach” to the management of risk throughout the total product life cycle of AI-enabled devices. We also saw, in January of this year, the U.S. administration issue the Executive Order Removing Barriers to American Leadership in Artificial Intelligence. These developments, and potential developments, need to be carefully taken into account by life sciences companies that are considering transacting with an AI/ML tool provider.
“Refreshed” UK-wide Innovative Licensing and Access Pathway (ILAP) Applications Now Open
Commercial and pre-commercial developers of potentially transformative medicines or drug-device combination products can now utilize a unique accelerated regulatory pathway in the UK. Article authored by Marie Manley and Victoria Kerr. (more…)
Unauthorized Drug Importation by Alternative Funding Programs: What Pharmaceutical Companies Need to Know and Options on How to Respond
Some entities known as Alternative Funding Programs (AFPs) are engaged in the unauthorized importation of specialty drugs into the United States and may pose a growing threat to the U.S. drug supply. Article authored by Benjamin B. Correa and Kathy P. Lee.
How Life Sciences Companies Can Respond To DOJ’s Focus on Clinical Trial Fraud
For the past two years, clinical trial fraud has been a key enforcement area for the U.S. Department of Justice’s (DOJ) Consumer Protection Branch (CPB). David Ludlow and Julea Lipiz set out considerations for life sciences companies to help mitigate scrutiny of their trial results and related products.
SEC Interest in FDA-Related Disclosures by Life Sciences Companies Highlighted
A recent SEC enforcement action against Cassava Sciences over misleading statements made to the FDA about clinical trial (CT) results highlights the importance of life sciences companies exercising care in how they disclose FDA-related information to investors. Lara Mehraban explains.
