Time for new ideas to address rising drug shortages

Kevin B. O'Reilly , Senior News Editor

As drug shortages continue to worsen and negatively affect patient care across the U.S., the AMA has adopted policy to strengthen its ongoing efforts to address this growing public health crisis. 

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The AMA’s recently adopted policy supports diversifying drug manufacturing and supply chains and stabilizing the generic drug market, as well as opposing practices such as pharmacy benefits manager formulary restrictions that worsen drug shortages. According to statistics from the American Society of Health-System Pharmacists, a spike in new drug shortages in 2022 has led to the highest levels of drug shortages in the U.S. since 2014.

“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,” said AMA Immediate Past President Jack Resneck Jr., MD.

“The nation’s drug supply shouldn’t be in constant turmoil because there aren’t enough manufacturers, or the profit margin is too thin to incentivize production,” Dr. Resneck added. “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.”

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Aimed at combating these drug shortages, the policy was informed by an AMA Council on Science and Public Health report that examined three root causes for drug shortages: the evolving prescribing landscape, modern challenges of advertising and patient demand, and the economics and fragility of generic drug manufacturing. The report also noted that drug shortages can be the result of factors such as decades-long policy choices causing a decline in domestic manufacturing, production quotas, and severe weather.

With a limited number of generic drug manufacturers, the majority of which are located overseas, any disruption to the marketplace can result in a multi-month-long shortage. The report outlines potential solutions, including exploring nonprofit or government-owned generic drug manufacturing.

At the most recent AMA Interim Meeting, the House of Delegates adopted new policy to:

  • Support activities which may lead to the stabilization of the generic drug market by nonprofit or public entities. Stabilization of the market may include, but is not limited to, activities such as government-operated manufacturing of generic drugs, the manufacturing or purchasing of the required active pharmaceutical ingredients, or fill-finish. Nonprofit or public entities should prioritize instances of generic drugs that are actively, at-risk of, or have a history of being, in shortage, and for which these activities would decrease reliance on a small number of manufacturers outside the United States.
  • Encourage government entities to stabilize the generic drug supply market by piloting innovative incentive models for private companies which do not create artificial shortages for the purposes of obtaining said incentives.

Delegates also amended existing policy to:

  • Support innovative approaches for diversifying the generic drug manufacturing base to move away from single-site manufacturing, increasing redundancy, and maintaining a minimum number of manufacturers for essential medicines.
  • Support the public availability of FDA facility inspection reports to allow purchasers to better assess supply-chain risk.
  • Oppose the practice of preferring drugs in shortage on approved pharmacy formularies when similarly effective drugs, in patient-appropriate formulations, are available in adequate supply yet otherwise excluded from formularies or coverage plans.
  • Continue to monitor proposed methodologies for and the implications of a buffer supply model for the purposes of reducing drug shortages and will report its findings as necessary.

Learn more with this Leadership Viewpoints column by AMA President Jesse M. Ehrenfeld, MD, MPH, about the reforms needed to alleviate persistent drug shortages.