House Committee Hearing Further Examines Worsening Drug Shortages

Posted February 12, 2012

The frequency of drug shortages has increased “dramatically” in recent years, requiring action on the part of physicians and scientists at St. Jude’s Children’s Research Hospital, the hospital’s chief pharmaceutical officer told the House Energy and Commerce Subcommittee on Health at a hearing Feb. 9.

“The most common childhood cancer is acute lymphoblastic leukemia, with about 3,000 cases per year. Approximately 90 percent of patients with ALL can be cured using a combination of up to 10 drugs,” said Bill Greene, PharmD, BCPS, FASHP, chief pharmaceutical officer of St. Jude’s Children’s Research Hospital. “Over the last decade, however, eight of those 10 drugs have become difficult, and at times impossible, to obtain. These frequent shortages insert additional and unnecessary complexity to curing children with ALL and other cancers.”

The subcommittee held the hearing to discuss the proposed generic drug user fees and build on its initial hearing on drug shortages last September.

“Every day we are hearing from providers in our districts about the increased difficulties in acquiring the drugs necessary to treat their patients,” said Rep. Joe Pitts (R-Pa.), subcommittee chairman.

Janet Woodcock, MD, director for the Center of Drug Evaluation and Research of the Food and Drug Administration, described in her testimony the steps FDA is taking to help alleviate and address the drug shortage crisis. When the FDA learns of potential shortages, it works directly with manufacturers to help prevent the shortage or minimize its effect by developing workaround solutions to manufacturing, or helping the manufacturer find additional sources of raw materials, she said. She also noted that since President Obama issued an Executive Order providing the FDA with additional authority on drug shortages, the agency has successfully prevented 114 drug shortages. Dr. Woodcock also noted that shortages have multiple causes, including economic issues.

Nevertheless, Dr. Greene testified that drug shortages are “making it difficult to provide the best possible patient care.” Shortages cause delays or termination of research in pediatric oncology, including at least 85 Children’s Oncology Group clinical trials. Shortages also add costs to the health care delivery system, he said.

He urged Congress to pass legislation (H.R. 2245 and S. 296) immediately to give FDA the tools it needs to prevent and minimize the impact these drug shortages have on pediatric care and research.

At the subcommittee’s earlier hearing last fall, ASCO incoming Government Relations Committee Chair Charles W. Penley, MD, testified how oncology drug shortages are impacting patient care.  ASCO will continue to engage with lawmakers, federal agencies and other stakeholders to work toward a comprehensive solution to our nation’s drug shortage crisis.

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