Reports: ‘Track and trace’ may be part of PDUFA reauthorization
NEW YORK — Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.
Politico reported that the Food and Drug Administration and industry stakeholders were debating about what a track-and-trace system, designed to keep counterfeit drugs out of the supply chain, would look like. Industry leaders, represented by the Pharmaceutical Distribution Safety Alliance, proposed requiring individual serial numbers for each lot of drugs, which could be checked against a central database.
The news site reported that industry stakeholders would prefer a national system over a system of state-by-state pedigree laws, but the FDA was not satisfied with what it was reported to regard as a weaker tracking system.
GSK, Auxilium to co-promote testosterone therapy
MALVERN, Pa. — The U.S. subsidiary of British drug maker GlaxoSmithKline and U.S.-based Auxilium Pharmaceuticals will co-promote a testosterone-replacement drug, the two said Monday.
GSK and Auxilium announced an agreement for the co-promotion of Testim 1% (testosterone gel), used in men with conditions related to deficiency or absence of the hormone.
"Today, GlaxoSmithKline and Auxilium have forged a collaboration to expand our reach to U.S. physicians who treat men with low testosterone and its resulting symptoms, known as hypogonadism, which we believe is a prevalent but poorly recognized condition," Auxilium president and CEO Adrian Adams said. "While the Auxilium sales force has consistently performed well in an increasingly competitive environment, adding the strength and breadth of GSK’s U.S. commercialization organization will further enhance our sales efforts with U.S. physicians who treat this condition."
Under the agreement — for which precise financial terms were not disclosed — GSK will have the exclusive right to co-promote Testim with Auxilium in the United States through September 2015. Auxilium will be responsible for commercial drug manufacturing, supply and regulatory activities, while GSK will receive compensation based on net sales and tail payments.
Testosterone therapies are about $1.6 billion per year, including $1.4 billion for testosterone gels, according to IMS Health.
Touro College of Pharmacy graduates first class
NEW YORK — The first new pharmacy school in New York in almost 70 years, and the only one in Manhattan, graduated its first class in a commencement ceremony at the New York Academy of Medicine on Friday.
The Touro College of Pharmacy, located in Harlem, announced the graduation of 63 students of the class of 2012. The school, part of the larger Touro College and University system, opened in 2008.
Students at the school undergo a "2+2" educational model that includes two years of instruction and two years of full-time experiential education. The college has established affiliations for students at 83 sites that include pharmacies, hospitals, community organizations, public agencies and public insurance organizations. The school says its mission is to improve public health by educating a diverse student body that will serve underrepresented communities and work to minimize health disparities.