ASHP Taking Steps to Address Drug Manufacturing Quality and National Security Risks

By Paul Abramowitz posted 27 days ago

  

Dear Colleagues,

A recently released report from the U.S.-China Economic and Security Review Commission underscores the need to address our nation’s dependence on China for the manufacturing of pharmaceuticals and their active product ingredients (API). In particular, the report recommends that Congress hold hearings on the topic and pursue new quality oversight mechanisms for foreign-sourced drug products.

The report shines a light on some foreign manufacturing practices that may pose national security and public health risks. We have previously called for the Department of Health & Human Services and the Department of Homeland Security to conduct a risk assessment of national security threats associated with manufacturing and distribution of critical drugs, their APIs, and associated medical devices used for preparation or administration. Relying predominantly on other countries for necessary ingredients to manufacture crucial drugs, APIs, and devices required to safely prepare and administer drugs presents a potential threat to the stability of the U.S. drug supply. Approximately 80 percent of API manufacturers are located outside of the U.S. - this leaves our supply chain vulnerable to disruption and puts API sourcing at risk.

To identify meaningful solutions, early next year ASHP will convene a summit in partnership with stakeholders and experts including government, medicine, nursing, hospitals, standards-setting bodies, manufacturers, supply chain and others to examine manufacturing quality and foreign sourcing of drug products and formulate recommendations to protect the safety and quality of the U.S. drug supply. This will build on our previous summits convened by ASHP, including the 2018 “Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Health Care Critical Infrastructure.” We will share more with you in the coming months as we continue to engage our partners and experts in this important area.

Please know that ASHP takes the long-term safety and quality of our nation's pharmaceutical supply very seriously, and will allocate the necessary resources to lead efforts to help ensure that our patients have consistent access to a safe and effective supply of necessary medicines.

Thank you for being a member of ASHP and for everything that you do for your patients and our profession.

Sincerely,

Paul

Clarification: A prior version of this blog indicated that more than 80 percent of API is produced in China and India. The blog was updated to reflect FDA’s data, indicating that approximately 80 percent of API manufacturers are located outside of the U.S.

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23 days ago

I have an editorial out in the Annals of Pharmacotherapy that touches on this very topic https://doi.org/10.1177%2F1060028019881692 . I also have one in press on the reasons behind NDMA contamination that might be helpful in this regard.  

26 days ago

​The recent findings with Dollar Tree/Dollar General also indicates there is room for improvement with controlling importation of products from questionable companies.

27 days ago

Thank you for taking on this important issue.  As you have stated it is vitally important that the United States leads in API production.