I am a little skeptical after reading how Ms. Hamburg handled the Avandia
situation.
Posted by Jef Akst, "The Scientist.com"
24th February 2010
The National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) announced a new collaboration this morning (Feb 24) that will support efforts in translational and regulatory science, including a contribution of $6.75 million in regulatory research grants over the next three years.
Since Margaret Hamburg took the reins as FDA commissioner last year, she has not been shy about her feelings regarding regulatory science -- research that relates the regulatory requirements of biomedical product development to the science that ensures the safety and efficacy of those products. If the production of new therapeutics were a rower, Hamburg has said, it would have one strong arm -- that of fundamental biomedical research and discovery -- but one scrawny arm -- the regulatory science counterpart. And unless the scrawny arm begins to bulk up, the translational side of research will largely just be moving in circles.
"Just as biomedical research has evolved in the past decades, regulatory science -- the science and tools we use to assess and evaluate product safety, efficacy, potency, quality and performance -- must also evolve," she said at the annual Regulatory Affairs Professional Society conference last September.
With today's announcement of the partnership between the NIH and the FDA, it seems Hamburg has got the NIH on her side. After years of working side by side, NIH director Francis Collins said in a meeting announcing the collaboration, and many recent talks with Hamburg at a local diner, the two agencies have finally come together in a collaboration that they call "the first of its kind."
In addition to the funding resources the new initiative will provide, the NIH and FDA are forming a joint leadership council, cochaired by Collins and Hamburg, to help integrate regulatory considerations from the FDA into biomedical research, and conversely, the latest science from the NIH into the regulatory review process. The initiative also plans to reach out to the scientific community, including private and nonprofit organizations bringing medicines to market, to seek input on how the two agencies can work together, starting with a public meeting this spring.
The goal of the "new partnership [is] developing more life saving cures and getting them to Americans faster," Health and Human Services Secretary Kathleen Sebelius said at the meeting this morning. "[It] is a great example of our new focus on leveraging all of our assets to reach our highest potential."
situation.
Posted by Jef Akst, "The Scientist.com"
24th February 2010
The National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) announced a new collaboration this morning (Feb 24) that will support efforts in translational and regulatory science, including a contribution of $6.75 million in regulatory research grants over the next three years.
Since Margaret Hamburg took the reins as FDA commissioner last year, she has not been shy about her feelings regarding regulatory science -- research that relates the regulatory requirements of biomedical product development to the science that ensures the safety and efficacy of those products. If the production of new therapeutics were a rower, Hamburg has said, it would have one strong arm -- that of fundamental biomedical research and discovery -- but one scrawny arm -- the regulatory science counterpart. And unless the scrawny arm begins to bulk up, the translational side of research will largely just be moving in circles.
"Just as biomedical research has evolved in the past decades, regulatory science -- the science and tools we use to assess and evaluate product safety, efficacy, potency, quality and performance -- must also evolve," she said at the annual Regulatory Affairs Professional Society conference last September.
With today's announcement of the partnership between the NIH and the FDA, it seems Hamburg has got the NIH on her side. After years of working side by side, NIH director Francis Collins said in a meeting announcing the collaboration, and many recent talks with Hamburg at a local diner, the two agencies have finally come together in a collaboration that they call "the first of its kind."
In addition to the funding resources the new initiative will provide, the NIH and FDA are forming a joint leadership council, cochaired by Collins and Hamburg, to help integrate regulatory considerations from the FDA into biomedical research, and conversely, the latest science from the NIH into the regulatory review process. The initiative also plans to reach out to the scientific community, including private and nonprofit organizations bringing medicines to market, to seek input on how the two agencies can work together, starting with a public meeting this spring.
The goal of the "new partnership [is] developing more life saving cures and getting them to Americans faster," Health and Human Services Secretary Kathleen Sebelius said at the meeting this morning. "[It] is a great example of our new focus on leveraging all of our assets to reach our highest potential."