Regulatory Roundup: FDA Approves the Influenza Vaccine Formulation for the 2011-2012 Flu Season

As part of FDA’s restructuring initiative (see “FDA Office of Compliance to Become a Super Office”), Commissioner Margaret Hamburg has announced that Dr. Steven Spielberg, former Dean of Dartmouth Medical School and currently Director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City, will serve as Deputy Commissioner for Medical Products and Tobacco, a newly created position. This position “will provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products,” according to Hamburg’s July 13 memo to the staff on the subject. It seems that Janet Woodcock will continue to serve as head of the Center for Drug Evaluation and Research, now under Speilberg. Deborah Autor, director of CDER’s Office of Compliance, will move to take on the role of Deputy Commissioner for Global Regulatory Operations and Policy. Dr. Murray Lumpkin, deputy commissioner for International Programs and director of the Office of International Programs, will take on the role of Senior Advisor and Representative for Global Issues. In addition to a directorate for food safety, another new position being created is a Chief Operating Officer of a new Office of Operations. No name for this position has been given as of yet. Other smaller changes are being made as well.

The European Commission’s Directorate General for Health and Consumer Policy (DG SANCO) opened for public comment EMA’s revised version of the Guideline on Good Distribution Practice of Medicinal Products for Human Use. Revisions to the 1994 guideline address new challenges in storing and distributing drug products and also aim to meet new requirements under the Directive 2011/62/EU on falsified medicines. Comments are due by Dec. 31, 2011.

FDA has approved the influenza vaccine formulation for the 2011-2012 flu season. Six manufacturers will produce and distribute the vaccine throughout the United States: CSL Limited’s Afluria; GlaxoSmithKline Biological’s Fluarix; ID Biomedical Corporation’s FluLaval; MedImmune Vaccines’ FluMist; Novartis Vaccines and Diagnostics Limited’s Fluvirin; and Sanofi Pasteur’s Fluzone, Fluzone High-Dose, and Fluzone Intradermal. The latter, Fluzone Intradermal, was approved in Ma 2011 and is only available to adults aged 18 to 64; this vaccine is delivered into the skin, rather than the muscle, using a small needle.