In response to the continuing shortage of drugs for cancer and other serious ailments, Representatives Diana DeGette (D-CO) and Tom Rooney (R-FL) introduced H.R. 2245,The Preserving Access to Life-Saving Medications Act, that would provide the Food and Drug Administration (FDA) with tools to help address and prevent future medication shortages. The new legislation will require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug and biological product shortages. This legislation is similar, but not identical to S. 296 introduced in February by Senator Amy Klobuchar (D-MN). Unlike the Senate bill, H.R. 2245 requires notification of shortages of all biological products, sets specific fines for non-compliance with reporting requirements, and authorizes a General Accountability Office study to examine the causes behind drug shortages.
ASH met with Representatives DeGette prior to the bill's introduction to brief her on the drug shortages of greatest concern to hematologists and oncologists and to ensure that the legislation addresses issues relevant to the supply and distribution of these drugs. In addition, ASH has requested a Congressional hearing on this topic as a means to call attention to the problem and determine effective approaches to addressing access issues when shortages occur. Read the latest update on the status of hematologic drug shortages, how ASH has responded to drug shortages, and what resources are available for physicians dealing with shortages.
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