FDA and Congress are putting forth new proposals to mitigate drug shortages, which continue to have a major impact on the US healthcare system.
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.
Related: Generic Epipen for kids may help with shortage
“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.
Related: Epipen shortage: Pharma maker, retailer offer aid
The Task Force offers 3 key recommendations to address the root causes of shortages:
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