“Biogenerics: It’s Not If, But When…and May Well be 2007″: Former FDA Commissioner Mark McClelland

The former Commissioner expects biogenerics to be high on FDA's agenda this year.  But we can also hope that safety will be properly addressed....the industry is currently having enough trouble ensuring the safety of its small molecule drugs. This just in from the Generic Pharmaceutical Manufacturers Association.  Former FDA Commissioner McClellan Says Biogenerics Legislation Is on the Horizon for 2007 Phoenix, AZ -- Former Food and Drug Administration (FDA) Commissioner Dr. Mark McClellan today said that he has always believed that when it comes to biogenerics, it is "an issue of when -- not if -- and it may well be this year" --  that Congress would pass legislation to create a clear, efficient abbreviated approval pathway for biogenerics. Dr. McClellan spoke at GPhA's Annual Meeting in Phoenix, Arizona. "I've always thought it was important to have a pathway for [biogenerics]," said Dr. McClellan. Dr. McClellan's remarks echo those delivered via satellite by Senator Orrin Hatch (R-UT) and Representative Henry Waxman (D-CA) yesterday. Both lawmakers were optimistic that biogenerics legislation will pass Congress this year. Biopharmaceuticals are everyday medicines used to treat conditions like heart disease, multiple sclerosis and cancer, but their costs are exceedingly high, sometimes as much as $200,000 per patient, per year. Generic versions of these products would enable more patients to have access to these life- saving medicines. In discussing biogenerics today, Dr. McClellan asked those supporting getting generic versions of these life-saving medicines to consumers to encourage the FDA to move forward with guidance documents and a white paper. "It was encouraging to hear speaker after speaker say that 2007 can be the year when biogenerics legislation becomes a reality," GPhA President and CEO Kathleen Jaeger. "Momentum is clearly growing, and that's good news for consumers, businesses, older Americans and the entire health care community." GPhA is urging Congress to approve the Access to Life-Saving Medicine Act, bipartisan legislation that would mandate that the FDA create a clear and efficient abbreviated approval pathway for generic versions of biopharmaceuticals. Former FDA Commissioner McClellan Says Biogenerics Legislation Is on the Horizon for 2007 Phoenix, AZ -- Former Food and Drug Administration (FDA) Commissioner Dr. Mark McClellan today said that he has always believed that when it comes to biogenerics, it is "an issue of when -- not if -- and it may well be this year" --  that Congress would pass legislation to create a clear, efficient abbreviated approval pathway for biogenerics. Dr. McClellan spoke at GPhA's Annual Meeting in Phoenix, Arizona. "I've always thought it was important to have a pathway for [biogenerics]," said Dr. McClellan. Dr. McClellan's remarks echo those delivered via satellite by Senator Orrin Hatch (R-UT) and Representative Henry Waxman (D-CA) yesterday. Both lawmakers were optimistic that biogenerics legislation will pass Congress this year. Biopharmaceuticals are everyday medicines used to treat conditions like heart disease, multiple sclerosis and cancer, but their costs are exceedingly high, sometimes as much as $200,000 per patient, per year. Generic versions of these products would enable more patients to have access to these life- saving medicines. In discussing biogenerics today, Dr. McClellan asked those supporting getting generic versions of these life-saving medicines to consumers to encourage the FDA to move forward with guidance documents and a white paper. "It was encouraging to hear speaker after speaker say that 2007 can be the year when biogenerics legislation becomes a reality," GPhA President and CEO Kathleen Jaeger. "Momentum is clearly growing, and that's good news for consumers, businesses, older Americans and the entire health care community." GPhA is urging Congress to approve the Access to Life-Saving Medicine Act, bipartisan legislation that would mandate that the FDA create a clear and efficient abbreviated approval pathway for generic versions of biopharmaceuticals.