Policy statement endorses diversifying supply chains, experimenting with government manufacture of generics
Calling the shortage a “growing public health crisis,” the AMA’s House of Delegates has adopted a policy in support of multi-site manufacturing, greater redundancy, and maintaining a minimum number of manufacturers for essential medicines. It also opposes including drugs that are in short supply on approved pharmacy formularies when similarly effective drugs are available but excluded from formularies or coverage plans.
“Drug shortages are the highest we’ve seen in a decade, making it more and more difficult for patients and physicians across the country to get necessary medications,” Jack Resneck, Jr., M.D., the AMA’s immediate past president, said in a statement. “We must continue to push for actions to mitigate drug shortages that will help ensure the drug supply chain is more resilient and adaptable so our patients can get the medications they need when they need them.”
The AMA cites data from the American Society of Health-System Pharmacists showing that the nation faces its highest levels of drug shortages since 2014. During the first quarter of 2023 the drug classes facing the greatest shortages were central nervous system therapies, antimicrobials, fluids/electrolytes, hormones, and chemotherapies.
The policy is based on a report from the AMA’s Council on Science and Public Health that identified three primary causes for the drug shortages: changes to the prescribing landscape, the challenges posed by advertising and patient demand, and the fragile economics of generic drug manufacturing. These are in addition to factors such as earlier policy choices causing a decline in domestic manufacturing, production quotas, and weather issues.
The report suggests potential solutions, such as exploring non-profit or government-owned generic drug manufacturing. For its part, the AMA's policy calls for stabilizing the generic drug market through activities led by non-profit or public entities, prioritizing instances of generic drugs that are at risk for, or have a history shortages. It encourages government entities to experiment with innovative incentive models for private companies.
In July the U.S. Senate took a step towards addressing the drug shortage when the Health Education Labor and Pensions Committee passed the Drug Shortage Prevention Act on a bipartisan vote. The law would require manufacturers of over the counter and prescription drugs to notify the U.S. Food & Drug Administration when they are unlikely to be able to meet demand for a particular drug.
In its policy statement the AMA pledged to “continue its commitment to work with other interested parties to further evaluate and implement recommendations that contribute to solutions for this critical public health issue.”