CLC Urges Strong Drug Shortage Provisions in User Fee Legislation
June 15, 2012
Dear Chairman Harkin, Chairman Upton, Ranking Member Enzi, and Ranking Member Waxman:
We are writing to express our appreciation for your efforts to address the crisis of drug shortages by including in the user fee bill enhanced requirements for reporting shortages. The undersigned cancer patient, physician, and researcher organizations and those they represent have experienced the disruptions in care and research that have resulted from shortages of life-saving cancer drugs. No group of patients – from the youngest children to seniors – has escaped the effects of drugs in short supply, and we applaud your efforts to address these problems.
To date the most serious cancer drug shortages have been sterile injectable drugs, but there have recently been shortages of biological products used in cancer treatment. The disruptions in manufacturing and distribution that have caused severe shortages of sterile injectables threaten all forms of cancer treatment. As you resolve the differences between the House and Senate bills, we urge that you remove any doubt about the application of the enhanced reporting requirements to biological products. We believe this step is critical to providing cancer patients, physicians, and researchers the full benefit of the drug shortage protections Congress has crafted.
Thank you in advance for considering this important clarification of the drug shortage provisions of the legislation you have developed.
Cancer Leadership Council
American Cancer Society Cancer Action Network
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