As reported last month (“Rheumatologists Struggle with Drug Shortages,” October 2011, p. 51), a bill (S. 296) proposed in the U.S. Senate would require drug manufacturers to notify the U.S. Food and Drug Administration (FDA) of factors that might lead to a drug shortage.
The FDA invites public comments regarding the Center for Drug Evaluation and Research’s approach to addressing drug shortages, and seeks insight about the causes and impacts of drug shortages and possible strategies for preventing or mitigating drug shortages. Because this issue affects the rheumatology community, the ACR encourages members to comment by December 23, 2011.
Comments may be submitted online at www.reg ulations.gov. To read the Federal Register announcement and for instructions to submit comments in writing, visit www.gpo.gov/fdsys/pkg/FR-2011-09-29/pdf/2011-25116.pdf.