COVID-19 is bringing more pressure to bear on Congress to pass S. 2723, the Mitigating Emergency Drug Shortages (MEDS) Act, which has been sitting in the Senate Health, Education, Labor and Pensions (HELP) Committee since Sen. Susan Collins (R-Maine) introduced it in October 2019 – a few months before the novel coronavirus emerged.
More than a dozen hospital associations and professional groups wrote to HELP leadership last week urging the committee “to advance this critical piece of legislation expeditiously.” The letter cited “concerns with the integrity of the drug supply chain and the potential impact on downstream drug shortages” due to the COVID-19 outbreak in China where many active pharmaceutical ingredients (APIs) and drugs are manufactured. The letter also mentioned vulnerabilities in the U.S. drug supply chain that were highlighted by previous public health emergencies such as H1N1, Ebola and Hurricane Maria.
“A major concern with the COVID-19 outbreak in China is the overreliance on a single nation for a significant portion of the United States’ drug supply,” the groups said. The MEDS Act would require an examination of that overreliance as a risk to national security and mandate that the Department of Health and Human Services (HHS) develop a report to Congress with recommendations to incentivize the domestic manufacturing of drugs and APIs.
The bill also would require manufacturers to report to the FDA the exact location of manufacturing for critical drugs, the exact source of all their raw materials, and their redundancy and contingency plans to ensure a stable supply. “This is all critical information to understand the true risk to the supply chain and potential drug shortages due to pandemics such as COVID-19,” according to the letter.
In addition, the legislation would require API manufacturers to report potential supply disruptions to the FDA. Currently, only manufacturers of finished drugs have to notify the agency of such risks. Expanding the reporting requirements to API manufacturers would create “an early warning system that would allow the FDA upstream visibility to appropriately assess risk and rapidly work to identify alternative sources of supply,” the organizations said.
So far, the FDA has had only one report of a drug shortage due to COVID-19, even though it has identified 20 sole-source drugs that are made in China. In the case of the shortage, the agency was informed after the shortage was reported that it was related to the outbreak’s impact on the manufacturing of an API used in the drug. While the FDA didn’t disclose the name of the drug for commercial reasons, it said alternatives are available.
At a White House Coronavirus Task Force meeting Sunday, March 1, FDA Commissioner Stephen Hahn said no other drug shortages have been linked to COVID-19.
The impact to medical device supplies is a little more of a question mark, as current law doesn’t require device manufacturers to report potential disruptions or even to respond to FDA queries about possible shortages. The MEDS Act doesn’t address that issue.
Regardless, as it has in prior emergencies, the FDA has taken proactive steps to keep in contact with device manufacturers and others in the supply chain, including hospitals and group purchasing organizations, asking them to keep the agency apprised of device shortages.
“We are aware of 63 manufacturers which represent 72 facilities in China that produce essential medical devices,” Hahn said last week. “We have contacted all of them. ... We are aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers. While the FDA continues to assess whether manufacturing disruptions will affect overall market availability of these products, there are currently no reported shortages for these types of medical devices within the U.S. market.”