ASH Calls on Congress to Take Action to Prevent Drug Shortages

2011-12-15

(WASHINGTON) – The American Society of Hematology (ASH), the world’s largest professional society concerned with the causes and treatment of blood disorders, today urged the Senate Committee on Health, Education, Labor, and Pensions to expand authority of the Food & Drug Administration and provide economic incentives to manufacturers of low cost generic drugs to prevent drug shortages.

In written testimony provided to theSenate Committee on Health, Education, Labor, and Pensionsfor their December15 hearing, “Prescription Drug Shortages: Examining A Public Health Concern And Potential Solutions,” the Society provides the perspective of its more than 16,000 member hematologists on the increasing problem of shortages of life-saving drugs. As a direct result of shortages of critical drugs, physicians have had to choose alternate, less effective, or sometimes more toxic therapies for their patients with hematologic diseases when their first-line treatments were no longer available.

The Society’s testimony also outlines the profound effects that shortages have – ranging from emotional distress to life-threatening outcomes – on patients with blood-related diseases, particularly those with cancers such as leukemia, lymphoma, myeloma, and sickle cell disease. In addition to detailing the specific, profound effects of current drug shortages on hematologists and their patients, ASH’s testimony outlines the Society’s specific recommendations toCongress to help alleviate the crisis, including:

  • Increasing FDA authority under The Preserving Access to Life-Saving Medications Act (S. 296/H.R. 2245)
  • Improving FDA communication with stakeholders
  • Examining the impact of current FDA requirements on shortages
  • Developing a national drug registry
  • Providing economic incentives to manufacturers of critical drugs, specifically looking at expanding “orphan drug” status to incentivize continuous production of generics

In addition to submitting comments to the Senate Committee on Health, Education, Labor, and Pensions, the Society has also submitted formal comments to the Senate Finance Committee, the House Energy & Commerce Committee Subcommittee on Health and the Environment, and FDA that expand on these recommendations and reinforce the Society’s stance that the current situation is unacceptable and action must be taken now to alleviate critical shortages.

Reporters who wish to arrange an interview with an ASH spokesperson may contact Andrea Slesinski at 614-352-5096 or aslesinski@hematology.org.

The American Society of Hematology is the world’s largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems by promoting research, clinical care, education, training, and advocacy in hematology. The official journal of ASH is Blood, the most cited peer-reviewed publication in the field, which is available weekly in print and online.

back to top