Noem Orders Study on Drug Shortages; Senate, White House Already On It

Given that her Presidential aspirations have zeroed out, you’d think Governor Kristi Noem might focus on governing instead of grandstanding. But Friday she issued yet another executive order that clamors for attention but takes no real or original action.

Executive Order 2023-07 orders the Department of Health to “investigate the medication shortages in South Dakota to determine the extent of this State’s reliance upon foreign-sourced medications and raw materials” and “identify all opportunities to mitigate medication or raw material shortages in South Dakota.”

Noem hotly touts her latest executive order as proof that she’s a better leader than Joe Biden:

My top priority as Governor is the health and safety of the people of South Dakota…. The Biden Administration’s failure to address this shortage is causing patient care to suffer, creating delays in treatment, and increasing the risk of medication errors and the use of less effective alternative treatments. Once again, South Dakota will step up and be the leader that Biden refuses to be [Gov. Kristi Noem, press release, 2023.05.12].

But this executive order isn’t leading; it’s plagiarizing a March 2023 report by the United States Senate Committee on Homeland Security and Governmental Affairs:

Noem EO 2023-07	HSGA report
Shortages of critical medications present serious health and national security risks that carry devastating, yet avoidable consequences for individuals who take prescription and over-the-counter medications	…drug shortages continue to present serious health and national security risks. These risks carry devastating, yet avoidable consequences for all Americans, including our military.
Medication shortages in the United States increased by thirty percent from 2021 to 2022 and reached a five-year high at the end of 2022, with 295 active drug shortages	Between 2021 and 2022, new drug shortages increased by nearly 30 percent. At the end of 2022, drug shortages experienced a record five-year high of 295 active drug shortages.
These shortages have cascading effects on patient care, causing delays in treatment, increasing the risk of medication errors, and requiring the use of less effective alternative treatments.	These shortages have cascading effects on patient care, causing delays in treatment, increasing the risk of medication errors, and requiring the use of less effective alternative treatments.
Continued overreliance on foreign sources for medications and their raw materials contributes to this issue.	However, drug shortages are not a new problem. They are caused by a number of factors, including economic drivers, insufficient supply chain visibility, and a continued U.S. overreliance on both foreign and geographically concentrated sources for medications and their raw materials.
Lack of transparency in pharmaceutical supply chains limits the ability to identify and address critical medication shortages.	Neither the federal government nor industry has end-to-end visibility of the pharmaceutical supply chain—from the key starting materials, APIs, finished dosage and various other manufacturers that are “upstream”—to the “downstream” suppliers, which include purchasers and providers. This lack of transparency limits the federal government’s ability to proactively identify and address drug shortages.
Efforts by the industry to prevent and mitigate drug shortages remain insufficient.	To date, federal and industry efforts to prevent and mitigate drug shortages remain insufficient.

EO 2023-07 demands the Department of Health report by June 12 on possible actions the state and the federal government may take to mitigate those shortages. DOH may as well plagiarize the recommendations produced by the Senate HSGA report:

1. Invest in domestic advanced manufacturing capabilities for critical generic drug products regularly in shortage: The federal government should build upon its efforts to engage industry and academic partners through private-public partnerships that incentivize strategic onshoring and advanced domestic manufacturing technologies for critical generic drugs. These partnerships should encourage the use of advanced manufacturing technologies for critical drugs prone to shortages and bolster ongoing collaboration between academia and industry to further build opportunities for workforce training programs that bridge the gap from research and development to commercialization. The federal government should also explore opportunities to engage in long-term contracts with diverse suppliers of critical generic drugs.
2. Conduct regular interagency medical supply chain risk assessments: To ensure the federal government is adequately prepared to identify and mitigate vulnerabilities in the medical supply chain, Congress should require HHS, DOD, and DHS to jointly conduct regular risk assessments. These assessments should also account for cybersecurity threats. The federal government, in coordination with industry partners should also regularly update the Essential Medicines list and use that as a guide for investing in critical drug products in the U.S.
3. Require manufacturers of life-supporting and life-sustaining drug products to report increased demand and export restrictions to the FDA: To improve the FDA’s ability to predict and prevent potential drug shortages, Congress should require manufacturers to report when they experience an increase in demand or export restriction. Congress should also require GPOs and distributors to report low hospital fill rates (e.g. what is ordered versus received), for example, if a hospital receives less than 80 percent of the product they ordered, to help increase the FDA’s visibility into downstream supply chain distributors and providers, and help minimize the gap between supply and demand.
4. The FDA should take steps to ensure its supply chain data can be used to monitor supply chain vulnerabilities and conduct predictive modeling: The FDA should prioritize its development of a key starting material database and improve coordination with interagency and industry partners to assess end-to-end supply chain visibility. As part of its continued data modernization efforts, the FDA should document how it plans to utilize manufacturer volume data to proactively identify supply chain risks and predict drug shortages.
5. Streamline private and public efforts to predict and mitigate potential supply chain vulnerabilities: The federal government should better coordinate efforts to integrate data sharing between interagency and industry partners through a singular initiative to map the entire pharmaceutical supply chain—from key starting material and API sources to distribution information. The initiative should use digital technologies to regularly conduct predictive analyses and proactively identify vulnerabilities.
6. Provide the FDA with mandatory recall authority for all drug products: Congress should provide the FDA with mandatory recall authority for drug products that present a serious danger to individuals’ health.

The Department of Health could also plagiarize the White House’s immediate March response to the Senate HSGA report. On March 22, the Biden Administration reminded us that President Biden signed an executive order last September to promote domestic biotechnology and biomanufacturing innovation. The White House followed up on order in March with additional recommendations for research and development in domestic biotech.

So Governor Noem is only following, not leading. The White House is already promoting increased domestic production of drugs. The Senate HSGA report recommends increased federal action and authority via the FDA to gather information and address drug shortages. Governor Noem has spent her career saying the federal government should have less power, not more, but the problems of monitoring and managing supply chains—especially busting up industry consolidation and pushing companies to produce less profitable pharmaceuticals, key problems identified in the Senate HSGA report—require government intervention in the market. And given the global complexity of those supply chains, there’s darned little one tiny state like South Dakota can do to contribute to solving medication shortages short of drilling wells in Castlewood and striking insulin.