Toggle

Regulations & EHS&S



SOCMA's BPTF testifies before US House Committee on Energy & Commerce about pharmaceutical supply chain


4th November 2019
Edward Price, President and CEO of SEQENS and a member of SOCMA’s Bulk Pharmaceutical Task Force BPTF), has called for reasonable regulations and increased collaboration between stakeholders. During a testimony before the House Committee on Energy & Commerce hearing on Pharmaceutical Supply Chains in a Global Economy on 30th October, the BPTF urged pharmaceutical ingredient developers and manufacturers, the US 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% of APIs are manufactured overseas because of economic constraints in the US and the need for specialized equipment, technology, science, training and skill set not readily available in the US, Price said during his testimony.
 
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 (GMP) are followed versus a broad-based regional review to ensure proper quality and safety practices.

The BPTF also asked the US 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.