What's Happening?
The FDA has introduced a PreCheck program aimed at encouraging the onshoring of drug production in the United States. This initiative is part of a broader effort to promote domestic manufacturing of critical medicines, following an executive order. The PreCheck program consists of two main components: providing early technical advice to selected manufacturers before their facilities become operational, and holding pre-submission meetings to expedite assessments of quality information. During a full-day meeting held at the end of September, industry representatives, including those from major pharmaceutical companies like AbbVie, Amgen, Eli Lilly, and Sanofi, expressed general support for the program. However, they also highlighted significant regulatory hurdles that remain unaddressed by the current scope of the PreCheck initiative.
Why It's Important?
The PreCheck program is seen as a promising step towards strengthening the U.S.-based pharmaceutical manufacturing sector, which is crucial for ensuring a resilient and secure domestic supply chain. By fostering collaboration between the FDA and industry, the program aims to streamline the process from site design to production. However, industry leaders have pointed out that existing regulatory challenges, such as pre-approval inspections and post-approval changes, continue to impede the growth of domestic manufacturing. Addressing these issues is vital for the program to achieve its full potential and for the U.S. to reduce its reliance on foreign drug production, thereby enhancing national security and public health.
What's Next?
The FDA has opened a call for written comments from industry representatives, which will close on October 30. This feedback will be crucial in shaping the future of the PreCheck program and addressing broader regulatory concerns. The agency may need to integrate the PreCheck initiative with other FDA programs to tackle the challenges faced by drug manufacturers. Industry leaders are advocating for changes in the timing of inspections and the process for authorizing post-approval changes, which could accelerate onshoring efforts and improve the efficiency of existing production facilities.
Beyond the Headlines
The PreCheck program represents a shift towards proactive collaboration between the FDA and the pharmaceutical industry, which could lead to long-term changes in regulatory practices. By prioritizing collaboration over oversight, the FDA aims to create a new paradigm in pharmaceutical regulation. This approach could set a precedent for other sectors, encouraging similar collaborative efforts to address regulatory challenges and promote domestic production across various industries.
