Senate Bill to Tackle Worsening Drug Shortages

Author(s):

Laura Enderle, Assistant Editor

Lawmakers say patients’ access to lifesaving drugs is in danger unless major policy changes are implemented.

US lawmakers took a “critical first step” in dealing with the issue of drug shortages, according to the American Society of Health-System Pharmacists (ASHP). Senators Amy Klobuchar (D, MN) and Bob Casey (D, PA) introduced a bill earlier this month that would give the FDA new tools to prevent and manage shortages of lifesaving medications.

According to ASHP figures, the number of medically necessary drugs in short supply has doubled over the past 5 years. Shortages are caused by a variety of factors, from scarcity of raw materials to big pharma mergers and acquisitions. When they do occur, pharmacists, physicians, and patients are often “among the last to know,” Senator Klobuchar said.

The Preserving Access to Life-Saving Medications Act (S. 296), introduced February 7, 2011, would increase the extent to which pharmaceutical companies share knowledge on impending shortages with regulators, health care professionals, and patients. Senator Casey said advanced knowledge is “one of the most important tools for combating problems associated with drug shortages.”

S. 296 would require drug makers to notify the FDA of any incident likely to result in a shortage, including major business decisions, changes in manufacturing, or any other interruption with the potential to impact production and distribution. It would also direct the FDA to provide timely public updates on shortages and identify immediate actions to address them.

In drafting the legislation, Senators Casey and Klobuchar incorporated recommendations developed by ASHP and other health care organizations at a summit held in November 2010. ASHP welcomed the bill, as did summit co-conveners the Institute for Safe Medication Practices, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the American Hospital Association.

“We are pleased to see a legislative proposal offered to address this critical issue and will advocate strongly for its passage,” said ASHP executive vice president and chief executive officer Henri R. Manasse, PhD, ScD. The complete text of S. 296 is available here. (link to: )

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