May 2008

pharmpro.com 43

Industry News

FDA Embarks on Major Hiring Initiative

Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as the FDA begins a multi-year hiring initiative. The FDA is hiring hundreds of individuals with bCience and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. It takes a large pool of talented people for the FDA to protect and promote the public health," said )ohn Dyer, FDA's Deputy Commissioner for Operations and Chief Operating Officer. "Each month there is a delay in bringing critical staff on board impairs the agency's ability to fulfill this mission," In fiscal year 2008 alone, the FDA is looking to fill more than 600 new positions and to backfill over 700 others to implement the FDA Amendments Act of 2007. the Food Protection Plan and the Import Safety Action Plan. The Office of Personnel Management has granted Direct-Hire Authority to the FDA, an operating division of the Department of Health

and Human Services. OPM's actions reflect the Administration's commitment to strengthening the agency quickly. Direct-Hire Authority is an appointing authority 0PM can give to federal agencies for filling vacancies when a critical hiring need or severe shortage of candidates exists. It expedites hiring of qualified candidates by eliminating certain rating and ranking preferences, .

'"^Genzyme And FDA At Odds Over Myozyme Manufacturing

Cenzyme recently announced that the FDA informed the company of its opinion that Myozyme produced at the I60L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the I60L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale. Larger scale production has aiready been approved In more than 40 countries. Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale, includ-

ing patients who participated in the Late-Onset Treatment Study (LOTS), Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe, Myozyme is the only treatment for Pompe disease - a severe, progressively debilitating and life-threatening inherited disorder affecting a very small number of people throughout the world. The FDA will require Genzyme to submit a separate biologies iicense application |BLA) to gain approval for Myozyme produced at the 2000L scale. The agency proposed that Genzyme initiate a rolling BLA review process by submitting results from the LOTS study. Genzyme expects the FDA to give the BLA priority review and to act on the application by the end of this year. The LOTS study, which met its co-primary efficacy endpoints, was undertaken to evaluate the safety and efficacy of Myozyme in juvenile and adult patients with Pompe disease. Genzyme had already been preparing to submit results from this study to the FDA to fulfill a post-market ing commitment. Genzyme anticipates that this process will culminate in the availability of two commercial versions of Myozyme in the United States one produced at the 160L scale and the other produced at the 2000L scale.

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