Bethesda, Md.— The American Society of Health-System Pharmacists (ASHP), together with 22 other health care organizations representing patients, clinicians, and hospitals, sent a
letter today to the Senate Committee on Health, Education, Labor and Pensions (HELP) urging improvements in draft legislation addressing the drug shortage crisis.
The Senate HELP Committee is currently drafting language to help solve the drug shortage crisis as part of its work to reauthorize the Prescription Drug User Fee Act. The signers of the letter acknowledge their appreciation of the Senate’s draft legislation; however, they are urging several improvements to ensure that the goal of eliminating generic drug shortages can be accomplished. Their suggestions include:
- Instituting civil monetary penalties or another enforcement mechanism to ensure compliance with the requirement for drug manufacturers to report production interruptions or product discontinuations;
- Including clinicians, patients, and supply chain members in the task force created by the legislation in order to promote inter- and intra-agency coordination, planning and decision making, as it is essential for the Food and Drug Administration (FDA) and other agencies to hear from these groups;
- Strengthening the language to require the FDA to provide public notification about drug shortages, including adding the reason for the shortage and the anticipated duration, when possible;
- Requiring the FDA and the Drug Enforcement Administration to work collaboratively, with appropriate flexibility where needed, in the development of quotas for manufacturers producing controlled drugs; and
- Urging the committee to call for additional resources to be allocated to the FDA to address drug shortages.
The letter also expresses support for certain aspects of the draft legislation, including:
- The early notification requirement, as the FDA has successfully helped to avert shortages when it has received advanced notification; and
- The inclusion of both biologics and biosimilar products in the draft bill, as their use is expected to become increasingly prevalent.
According to data available on ASHP’s Drug Shortages Resource Center, which has tracked drug shortages for more than 10 years, the recent shortage is the worst in U.S. history. “The number of drug shortages has significantly increased over the last four years,” said ASHP CEO Paul W. Abramowitz, Pharm.D., FASHP. “This is a public health crisis that is putting patients at risk.”
The following organizations signed the letter:
- Academy of Managed Care Pharmacy
- Susan G. Komen for the Cure Advocacy Alliance
- American Academy of Emergency Medicine
- American Academy of Emergency Medicine Resident and Students Association
- American College of Clinical Pharmacy
- American Psychiatric Association
- American Society for Parenteral and Enteral Nutrition
- American Society of Clinical Oncology
- American Society of Health-System Pharmacists
- American Society of Hematology
- Children’s Hospital Association
- Association of Community Cancer Centers
- Cleveland Clinic
- Continuum Health Partners
- Hematology/Oncology Pharmacy Association
- Hopkins
- Institute for Safe Medication Practices
- Medical University of South Carolina Children's Hospital
- National Community Pharmacists Association
- NYU Langone Medical Center
- Society of Critical Care Medicine
- Stanford Hospital and Clinics
- Trinity Health
- University of Michigan Health System
- University of Utah
About ASHP
For more than 60 years, ASHP has helped pharmacists who practice in hospitals and health systems improve medication use and enhance patient safety. The Society's 35,000 members include pharmacists and pharmacy technicians who practice in inpatient, outpatient, home-care, and long-term-care settings, as well as pharmacy students. For more information about the wide array of ASHP activities and the many ways in which pharmacists help people make the best use of medicines, visit ASHP's website, www.ashp.org, or its consumer website, www.SafeMedication.com.
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