The American Society of Health-System Pharmacists (ASHP) applauds the U.S. House of Representatives for yesterday’s nearly unanimous passage of the Food and Drug Administration Reform Act (H.R. 5651).
“The House’s overwhelming 387-5 vote moves our health care system closer than ever to a meaningful solution to the public health crisis caused by drug shortages,” said ASHP CEO Paul W. Abramowitz, Pharm.D., FASHP. “We are gratified that our efforts have led to us to this point and look forward to continuing to work with Congress as the House and Senate work out the differences in their bills.”
H.R. 5651 requires drug manufacturers to notify the Food and Drug Administration (FDA) as soon as possible if they experience a product interruption and six months in advance if a product will be discontinued. Manufacturers who do not comply with this requirement would automatically receive a letter from the FDA asking the reason for non-compliance. Companies would have 30 days to respond. Early notification is a critical element in alleviating shortages. In 2011, the FDA was able to avoid 195 shortages because they had advance notice from manufacturers.
ASHP, in collaboration with key partners, including the American Hospital Association, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices, worked closely with a bipartisan group of legislators to develop the drug shortages provisions in the bill.
The legislation also requires the FDA to develop a drug shortage list and include where applicable, the name of the drug, the manufacturer, the reason for and duration of the shortage. The bill also requires the Secretary of Health and Human Services, the Government Accountability Office, and the Attorney General to conduct studies on drug shortages and report their findings to Congress.
ASHP has a long history of leading efforts to help the health care community manage issues related to drug shortages, including maintaining the ASHP Drug Shortages Web Resource Center and publishing guidelines to help practitioners manage drug product shortages.
The Society was a co-convener of a summit in November 2010 that brought together stakeholders to develop recommendations for new approaches to prevent patient harm and minimize disruptions in care caused by drug shortages.
ASHP is the national professional organization whose nearly 40,000 members include pharmacists and pharmacy technicians who provide patient care services in acute and ambulatory settings, including hospitals, health systems, and clinics, as well as pharmacy students. For 70 years, the Society has been on the forefront of efforts to improve medication use and enhance patient safety. 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.