Bill Greene, Pharm.D., BCPS, FASHP, chief pharmaceutical officer at St. Jude Children’s Research Hospital in Memphis, stressed the need for immediate action to solve the ongoing drug shortage crisis during a hearing last Thursday held by the health subcommittee of the House of Representatives Energy and Commerce Committee.
Greene’s testimony described the challenges that shortages pose for caregivers at St. Jude and other hospitals around the country. He noted that shortages cause delays or termination of research in important fields like pediatric oncology, including at least 85 Children’s Oncology Group (COG) clinical trials. To illustrate the impact that shortages have on patients, Greene shared the story of Lucy, a five-year old brain tumor patient, who experienced thiamine deficiency due to the unavailability of a multivitamin solution.
ASHP submitted a statement for the record to the subcommittee that provided examples of policy options that Congress should pursue to alleviate drug shortages, including the early warning system included in H.R. 2245, The Preserving Access to Life-Saving Medications Act. The Society also advocated examining the impact of the Drug Enforcement Administration’s (DEA’s) quota system on shortages of controlled drugs and inclusion of a generic drug user fee in the reauthorization of the Prescription Drug User Fee Act (PDUFA) for use as economic incentives for manufacturers.