“Biogenerics: It’s Not If, But When…and May Well be 2007″: Former FDA Commissioner Mark McClelland
March 3, 2007
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 2007Phoenix, 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 2007Phoenix, 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.
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