Marco Rubio (R-FL) and a group of bipartisan senators (including Elizabeth Warren (D-MA)) is promoting a bill which would limit US reliance on drugs and drug ingredients coming from China.

These senators view reliance on China as a national security threat. They have a point. While we would never rely on China for traditional security apparatus, we have been happy to allow China to provide the basis of our pharmaceuticals. As this pandemic is showing us, shortages cause problems, including higher death rates.

So what are some of the specifics?

1. Direct the Department of Defense (DoD) to determine the extent of its dependency on foreign entities for drugs, active pharmaceutical ingredients (API), and pharmaceutical components. Additionally, DoD would be required to determine whether this creates a national security issue and to make recommendations to eliminate US dependency on foreign sources.

Part of this information is already available with the Food and Drug Administration (FDA). The FDA already knows the location of manufacture and any change to the location or the process requires the manufacturer to file a Type II variation. The problem is that the FDA does not disclose this — despite the Freedom of Information Act (FOIA) agency requests — because it considers this information “proprietary”. This needs to change. The FDA needs to tell us where the source of the API and the Finished Dosage formulation is. 

It would be helpful if this bill mandated that the manufacturer must disclose the location of manufacturer of the specific batch of the product on the label so that pharmacists on down know where the product is actually made.

2. Requires drug makers to provide the Food and Drug Administration (FDA) with information to determine volume of APIs used in pharmaceuticals.

This is a good idea in principle. The Drug Shortages Task Force can use this to project upcoming shortages. But then what? We should mandate a risk-mitigation strategy where any drug that is on the “national list of essential medicines” has at least two sources of API/dosage, not in the same geography. That way, even if one of these locations is in China, we have a back up.

3. Restores Buy American Act’s intent for DoD and Department of Veterans Affairs (VA) purchases

Nationalization and protectionism is very shortsighted. Here is an example. Oxford (Jenner Institute) is in advanced stages with a vaccine candidate for COVID-19 which will be manufactured at the Serum Institute in Pune, India. This is the most advanced clinical candidate for vaccines today. By adding this clause to the legislation, we will be twisting ourselves into a pretzel if that candidate succeeds in clinical studies, depriving the VA of the vaccine, which will require us to go back and amend the law (if this bill were to eventually pass).

A less significant bill (because it is not bipartisan) is being promoted by Tom Cotton (R-AR) and Ted Cruz (R-TX). In essence, this would require the FDA to establish a registry to track APIs and institute a country-of-origin label for imported drugs. The bill would provide economic incentives for producing pharmaceuticals and medical equipment in the United States. The bill also would prohibit federal agencies and health facilities from purchasing APIs and other pharmaceutical products manufactured in China without an FDA waiver certifying that China is the sole source.

Currently, both bills are referred to the Senate Finance committee, and neither Rubio nor Cotton are on this committee. It is quite likely that Chuck Grassley, Chairman of the Finance Committee, would ultimately create his own bill and potentially take parts of bills when Congress returns. Grassley has long been a China hawk, and has repeatedly called into question our reliance on China for pharmaceuticals.

While these may just be merely messaging bills — Rubio in particular got out in front of the pandemic and essentially was one of the lead authors of the Paycheck Protection Program — they may well lead to anti-China drug policy in the near future.

More generally, China may be the concern when it comes to national security, but India and other nations where drug manufacturing is done do not live up to western standards. This leads to all sorts of quality problems and can drive shortages. I will continue to return to these broader issues in future blogs.

This article first appeared at the American Enterprise Institute.

Image: Reuters.