Today, supplies of more than 300 commonly used drugs in the U.S. are experiencing shortages. That's compared to supplies of maybe 40 or 50 commonly used drugs in the U.S. experiencing shortages 20 years ago, according to Rep. Larry Bucshon (R-Ind.), vice chair of the House Energy and Commerce Subcommittee on Health.
The shortages, combined with the U.S.'s increased independence on foreign nations for critical drug ingredients, represent a national security issue he and other congressional lawmakers hope to address, Bucshon — who will retire at the end of the year — said during a panel discussion with The Hill.
"Keeping Pharmacy Shelves Filled: Solutions to Address Drug Shortages," hosted by The Hill and sponsored by the Healthcare Distribution Alliance, also included panelists such as former FDA Commissioner Dr. Mark McClellan, Brookings Senior Fellow Dr. Marta Wosińka and more. Kathleen Koch, contributing editor at The Hill, moderated the panels.
“Active pharmaceutical ingredients are really critical for the U.S., and has started to go into the national security space,” Bucshon said. “Maybe 20% at the most 25% of those are produced in the U.S."
“We saw during the pandemic how that could be problematic, so I’m concerned about that particularly since a lot of manufacturing happens in China because of the tension that we have with the Chinese, and they have threatened sometimes to withhold APIs,” he added.
Bucshon also spoke about bipartisan legislation he has been working on that aim to better empower the U.S. Department of Health and Human Services (HHS) and drug companies to avoid future shortages and mitigate national security concerns about the drug supply chain.
Rep. Doris Matsui (D-Calif.) and Bucshon introduced a bill in January —the MAPS Act — that would empower HHS to create a supply chain map for the U.S. of certain drugs and key ingredients. The database accompanying the map would also include information such as the country of origin and quantity manufactured. No federal agency currently has a complete view of the drug supply chain in the U.S.
“Our hope is that with this map, HHS and all the experts know what they’re doing as it relates to supply chain, as it relates to distribution, as it relates to product manufacturing,” Bucshon said. “If you have the data, then you can understand what the vulnerabilities are and then maybe you can address them.”
Bucshon also noted that the will among congressional lawmakers to address these national security concerns and alleviate drug shortages in the U.S. is largely bipartisan.
“There's some disagreement between the political parties on how to solve production differences, but they're very, very small,” he said.
Industry experts at the event agreed the map would be an essential step forward for the federal government to determine vulnerabilities in the current U.S. drug supply chain and invest in strengthening it.
“The maps bill can be helpful,” Wosińka said. “The maps bill would help us asses potentially the exposure of where the drugs come from instead of just using this to assess vulnerability."
With that type of information, Wosińka explained, "We can start thinking about where the government would need to invest."
Bucshon and other panelists also discussed working to alleviate generic drug shortages, which account for a significant proportion of drugs currently facing shortages.
Much of the current shortage problems stems from shortages among generic versions of drugs, according to McClellan. The low margin on generic production has made stable generic drug production increasingly difficult, added.
“One is the existing, persistent shortages of which largely are generic, sterile injectable drugs and hospitals,” Wosińka added. “That's really where 60 percent of shortages are coming from.”
