House Subcommittee Holds Hearing on Chronic Drug Shortages in the U.S.

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ACP weighed in with statement in favor of legislation that ensures price transparency, allows drug price negotiation and bolsters the competitive market for generic drugs

March 8, 2024 (ACP) -- The American College of Physicians recently provided a statement to a House subcommittee that held a hearing on mitigating drug shortages, bolstering the resiliency of the global pharmaceutical supply chain and reversing the harmful effects of drug shortages on patient care.

"ACP is encouraged to see that Congress is working toward solutions to address this important issue, and we support bipartisan policies that will strengthen the supply chains of essential medications in this country," said George Lyons Jr., Esq., ACP director of legislative affairs. "We hope the statement will inform Congress of specific legislation we cite that they can pass to address drug shortages in the future."

The hearing, held by a subcommittee of the House Ways and Means Committee on Feb. 6, featured testimony from witnesses representing oncologists, pharmacists, supply chain managers and medical educators. "These witnesses informed the subcommittee on the drug supply chain, the need for transparency and the harmful effects upon those with debilitating health conditions as a result of not being able to receive their drugs," Lyons explained. "The hearing is one of two House jurisdictional hearings on drug shortages. The other was before the House Energy and Commerce Committee last year."

In its invited statement, ACP told the subcommittee that "the effect of drug shortages on the health care system and patients cannot be overstated. … ACP is concerned that under the status quo, a lack of strategy to mitigate drug shortages will result in the development of more serious health issues and, in turn, lead to diminished quality of life, poorer outcomes and additional financial burden to the health care system."

According to Lyons, ACP supports policies that would bolster collaboration between the federal government and pharmaceutical companies to ensure there is an adequate supply of pharmaceutical therapies and vaccines to protect and treat the U.S. population. The letter mentions that ACP supports several bills that could improve consumer access to affordable prescription drugs and mitigate the effects of drug shortages.

"Specifically, if necessary to mitigate an existing shortage and protect the general welfare of the public, ACP supports the government invoking federal law to allow generic drugmakers to bypass a drug manufacturer's patent to produce a drug for the government," Lyons said. "Further, we are supportive of exploring the role of the U.S. Food and Drug Administration in ameliorating drug shortages. We believe that the FDA could play a part in improving communication and documentation along the supply chain -- e.g., among product manufacturers, the FDA, suppliers, pharmacists and physicians -- to prevent and reduce drug shortages."

What are the chances that legislation will pass? "This is a key issue in Congress, as both Democrats and Republicans are interested in the issue," Lyons said. "Both the House and Senate have conducted hearings, and ACP has submitted statements and letters to the House committees as well as the Senate HELP (Health, Education, Labor and Pensions) Committee."

Among the bills that ACP supports, legislation to require openness in pricing is most likely to become law, Lyons said. "While this legislation was excluded from current appropriations negotiations, there has been bipartisan support in Congress to pass legislation aimed at more pricing transparency for hospitals, pharmacy benefit managers and drug companies," he said. "The House passed legislation calling for more transparency, and it awaits an outcome in the Senate."

However, Lyons noted, passage is less likely for legislation that would increase the number of drugs for which Medicare can negotiate the price and for legislation that would implement measures to ease the entrance and availability of generics in the marketplace.

"There is considerable opposition to these measures by pharmaceutical companies," he explained. "Drug companies have sued Medicare to challenge and/or delay implementation of its ability to implement regulations for negotiating drug prices, even after it was given that authority with the enactment of the Inflation Reduction Act."

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