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NABP e-News: August 21, 2008
Appellate Court Ruling Upholds Injunction of FDA Pedigree Rule
The US Court of Appeals for the Second Circuit in New York has upheld an injunction of the Food and Drug Administration (FDA) rule regarding pedigree requirements for wholesalers. FDA issued the requirements, which went into effect on December 1, 2006, to implement provisions of the Prescription Drug Marketing Act of 1987, as amended by the Prescription Drug Amendments of 1992. The injunction prohibits FDA from implementing the language in the regulation that 1) requires a pedigree to identify each prior sale, purchase, or trade of a drug back to the drug's original manufacturer, and 2) that specifies the different types of information, including lot numbers and container sizes, that must be included in a pedigree. The injunction does not affect other parts of the regulation.
FDA has indicated that, as long as the court's order is in effect, it does not intend to initiate any enforcement actions against any wholesalers solely for failing to include lot numbers, dosage, container size, or number of containers on a pedigree; or for failing to provide a pedigree that goes back to the manufacturer so long as the pedigree otherwise identifies the last authorized distributor of record that handled the drugs. More information is available on the FDA Web site.
Kansas Board Partners with KBI in Pilot Program to Combat Methamphetamine Use
The Kansas State Board of Pharmacy has partnered with the Kansas Bureau of Investigation (KBI) in a pilot program to combat methamphetamine use in western Kansas. The Board and KBI are joining forces with MethShield, a real-time Web-based tool that enables pharmacists, retailers, and law enforcement officials to track the sale of over-the-counter medications containing pseudoephedrine, a precursor substance used in the illicit manufacture of methamphetamine. The year-long pilot program was set to begin in mid-August at 128 pharmacies and drugstores across 62 counties in Kansas. A similar tracking system introduced in Australia was described in a presentation at the NABP 103rd Annual Meeting in 2007. The system, called Project STOP, is a real-time Web-based tool developed by the Pharmacy Guild of Australia to track the sale of pseudoephedrine-containing products. Like MethShield, it enables pharmacies, law enforcement, and regulatory agencies to share information. Since its inception in Queensland, Project STOP reportedly has contributed to a 23% decrease in the number of clandestine drug laboratories and has assisted in more than 30 arrests.
Comments Due August 27 on Proposed Rule to Study Drug Effects on Pregnant Women
Food and Drug Administration is accepting comments thought August 27, 2008 on its proposed rule calling for drug labeling to provide more complete information about the effects of medicines used during pregnancy and breast-feeding. FDA proposes that the pregnancy and lactation subsections of labeling include a summary of the risks of the medicine to the fetus or breast-feeding infant, and a discussion of the data supporting that summary. Revised labeling also would include clinical information useful for counseling pregnant or lactating women about medications, and for prescribing and managing the use of those medications. The proposed rule would eliminate the current pregnancy categories A, B, C, D, and X, and would require some companies to fund studies on approved drugs in an attempt to create a consistent and concise format of information. The proposed rule (Docket No. FDA-2006-N-0515) is published in the May 29, 2008 Federal Register. More information and the proposed rule is available from the FDA Center for Drug Evaluation and Research.
Amgen Strengthens Safety Information on Labeling for Erythropoiesis Stimulating Agents
NABP As of August 6, 2008, Amgen has strengthened the safety information on labeling for Epogen®/Procrit® (Epoetin alfa) and Aranesp® (darbepoetin alfa) for health care professionals and patients. The manufacturer revised the prescribing information to clarify the Food and Drug Administration (FDA)-approved conditions for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer and revised directions for dosing to state the hemoglobin level (> 10 g/dL) at which treatment with an ESA should not be initiated. The new label states that ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
The new medication guide contains information that FDA has determined is necessary for patients’ safe and effective use of ESAs and that could affect patients’ decision to take this drug. More information is available on the FDA MedWatch Web site
