June 27, 2012

Pharmacy Groups: Allow Wider Sharing
of Repackaged Scarce Drugs

Washington, D.C.Key pharmacy groups have joined other provider organizations in trying to make sure the proposed FDA Safety and Innovation Act does enough to resolve ongoing drug shortages. A version of the bill passed the Senate last month.

One of the issues addressed in letters sent to members of Congress is the legality of repackaging noncontrolled medications in short supply for use within the same health system, not just the same building; the associations say a House version of the bill includes a better approach.

"In addition, if there is a willingness among the conferees to enable both hospital and non-hospital providers (such as oncology clinics) within the same health system to have access to repackaged drugs in short supply, we would endorse such a technical correction," the organizations add.

The 20 groups, including the American Society of Health-System Pharmacists, National Community Pharmacy Association, the Hematology/Oncology Pharmacy Association, the Institute for Safe Medical Practices, the American College of Clinical Pharmacy, and the Academy of Managed Care Pharmacy, say they strongly support early notification requirements in both versions of the bill, noting early notification helped the FDA avoid 195 shortages in 2011.

The letters also request that drugs and biologics be included within the early notification requirements and be broadly defined to cover "complex and critical uses such as drugs used in surgery and emergency medicine, drugs used in cancer treatment, as well as drugs and biologics used to treat blood and other disorders." The groups also ask that human plasma protein therapies and their recombinant analogs not be exempt from early notification requirements.

While no civil monetary penalties for failing to notify FDA are included in either version of the bill, the provider associations strongly endorse them while also suggesting some alternative actions to make drug companies more accountable.

"We continue to believe that monetary penalties would represent the most effective mechanism to encourage reporting; however, given that this is currently not an option in either bill, we support the approach taken in the House version whereby a failure to report by a manufacturer would trigger an automatic letter by FDA to that company requesting an explanation of why it did not report to FDA," the letter to House and Senate leadership explains. "As these letters and responses would be a matter of public record, as are other FDA enforcement actions, manufacturers would be held accountable for justifying failure to report a stoppage in production of a life-saving product that could result in patient harm or death."

U.S. Pharmacist Social Connect