FDA's Woodcock details national security risks of global supply chains
Democrats and Republicans alike have become increasingly concerned in recent years about the potential downsides of the tight integration of US and Chinese supply chains in multiple industries. Such concerns manifested in a recent Subcommittee on Health of the Committee on Energy and Commerce hearing, titled ‘Safeguarding Pharmaceutical Supply Chains in a Global Economy’.
Janet Woodcock, director of the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA), was among the experts who testified at the hearing.
Woodcock was unable provide information to quell concerns about the negative implications of the reliance of the US pharmaceutical industry on Chinese manufacturing facilities.
In a statement, Woodcock said, “We do not have information that would enable us to assess the resilience of the US manufacturing base, should it be tested by China’s withdrawal from supplying the US market. We do know that the US drug supply is being compromised by drug shortages, in most cases triggered by manufacturing quality problems by US-based, as well as foreign, producers.”
Woodcock’s statement reflects the limited picture the FDA has of global supply chains.
The FDA knows that the number of registered active pharmaceutical ingredient (API) facilities more than doubled between 2010 and 2019. However, the agency lacks information on how the volume of Chinese APIs used in US medicines has changed over that period, rendering it unable to tell how reliant the industry is on imported ingredients.
A similar data gap is undermining efforts to assess the resilience of the US manufacturing base. In the absence of data on the volumes of Chinese APIs and spare capacity in the US, FDA is unable to do the gap analysis needed to gauge how the country would cope without imported ingredients.
Some people involved in relations between the US and China see these knowledge gaps as a problem, given the nature of global supply chains. Michael Wessel, commissioner of the US-China Economic and Security Review Commission, articulated those concerns at the hearing.
Wessel said, “As with China’s decision to threaten the supply of rare earths to Japan several years ago, China could weaponize its position in the supply chains to our disadvantage and peril.”
To mitigate the threat, Wessel wants the US to identify critical medicines and ensure they are supplied by multiple, domestic sources.
