Arlington, VA – Edward Price, President and CEO, SEQENS N.A. and a member of SOCMA’s Bulk Pharmaceutical Task Force, today called for reasonable regulations and increased collaboration between stakeholders during testimony before the House Committee on Energy & Commerce hearing on Pharmaceutical Supply Chains in a Global Economy.
BPTF urged pharmaceutical ingredient developers and manufacturers, the U.S. Food and Drug Administration (FDA) and state and federal legislators to work together to expand capacities and facilities for U.S. manufacturing of APIs.
As of 2019, nearly 80 percent of APIs are manufactured overseas because of economic constraints in the U.S. and the need for specialized equipment, technology, science, training and skill set not readily available in the U.S., Price said during his testimony.
“The reality of today’s pharmaceutical supply chain (especially in generics) is that the overwhelming majority of drug product manufacturers are not drug substance manufacturers, and the majority of drug substance manufacturers are not drug product manufacturers,” said Price.
“Many early-stage pharmaceutical companies want to work in the U.S., which has positively benefited my company’s two facilities located in Massachusetts,” he said. “As a U.S.-based API manufacturer, SEQENS N.A. is uniquely positioned because we produce the key raw material for use in any drug product or therapeutic that our customers may be looking to bring to market.”
With increased concerns about safety and reliability to prevent drug shortages, Price urged the FDA to ensure each pharmaceutical supplier is reviewed and audited on its own operations and current Good Manufacturing Practices are followed versus a broad-based regional review to ensure proper quality and safety practices.
BPTF also asked the government to:
- Target “at-risk products” and sectors of the industry to address existing shortages and have the FDA partner with companies to develop and make sure there is adequate safe, supply of at-risk drugs, giving exclusivities, or expediting reviews.
- Improve the academic base for the pharmaceutical industry by promoting STEM education so industry can have a steady stream of qualified workers in the U.S.
For a copy of the full testimony, visit: www.bptf.us.
The Bulk Pharmaceuticals Task Force, an affiliate of SOCMA, is an industry trade organization representing manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients.
SEQENS North America is a Pharmaceutical Development CDMO based in Newburyport, Mass., an integrated global leader in pharmaceutical synthesis and specialty ingredients with 24 manufacturing sites and 3 R&D centers in Europe, North America and Asia.