Congress, FDA working to reduce drug shortages

FDA and Congress are putting forth new proposals to mitigate drug shortages, which continue to have a major impact on the US healthcare system.

Senator Susan Collins (R-ME) and Senator Tina Smith (D-MN) recently introduced the Mitigating Emergency Drug Shortages (MEDS) Act, which is garnering support from the American Society of Health-System Pharmacists and other organizations.

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“We strongly support the MEDS Act as an important step toward ending drug shortages and believe that it will achieve lasting solutions, including requiring manufacturers to be transparent about causes of drug shortages and sources of active pharmaceutical ingredients, while also establishing contingency plans to maintain supplies in the event of manufacturing disruptions,” said ASHP CEO Paul W. Abramowitz, PharmD, FASHP, in a statement. “The ongoing shortages of vital, life-saving medications continue to jeopardize patient care in the United States.

“Pharmacists and other healthcare providers struggle to obtain reliable supplies of essential medications, resulting in delay or prevention of treatment, serious harm to patients, and unnecessary added costs to our healthcare system,” Abramowitz, added.

Meanwhile, FDA’s inter-agency Drug Shortages Task Force issued a report, “Drug Shortages: Root Causes and Potential Solutions,” which attempts to identify root causes and offer solutions.

The Task Force analyzed 163 drugs that went into shortage from 2013 to 2017 and compared these medicines to similar drugs that did not go into shortage.

“Many manufacturers reported discontinuing the production of drugs before a shortage for commercial reasons (e.g., loss of profitability). These results suggest a broken marketplace, where scarcity of drugs in shortage or at risk for shortage does not result in the price increases predicted by basic economic principles.,” said Acting FDA Commissioner Norman E. "Ned" Sharpless, MD, and Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in the statement.

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The Task Force offers 3 key recommendations to address the root causes of shortages:

• Take steps to increase understanding of the impacts of drug shortages and companies’ contracting practices that may contribute to them. “Currently, there is little private- or public-sector effort to collect and analyze comprehensive information to characterize shortages, quantify their effects, or closely observe the contracting practices that may be driving them,” Sharpless and Woodcock said. “This information would help improve stakeholders’ understanding of the impact shortages have on the Nation’s health care and support private- and public-sector strategies to prevent or mitigate them in the future.”
   

• Develop a system to measure and rate a facility’s quality management maturity. “The rating would evaluate the robustness of a manufacturing facility’s quality system and its ability to deliver high-quality products reliably and without disruption,” Sharpless and Woodcock said.
   

• Consider new contracting approaches that help ensure a reliable supply of drugs. “This may include providing financial incentives to make certain that manufacturers, especially of older generic drugs, earn sustainable returns on their products,” Sharpless and Woodcock said. “The combination of more complete information about contracting practices and greater transparency of the quality management maturity of specific manufacturing sites would enable payers, purchasers, and GPOs to consider new contracting approaches aimed at making sure there is a reliable supply of medically important drugs.”

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