10.03.11
Since the beginning of the year, the U.S. Food and Drug Administration (FDA) has made considerable progress in the way it reviews and approves medical products, U.S. Department of Health and Human Services Secretary Kathleen Sebelius contends.
In January, the FDA announced 25 steps it would take this year to improve the predictability, consistency, and transparency of its premarket review programs. As of late September, more than half of those steps have been completed and others are well on their way to implementation, she told medical device executives and industry leaders during plenary luncheon on the closing day of AdvaMed 2011—The MedTech Conference in Washington, D.C.
For example, the FDA recognized the need for greater consistency in the scientific programs and policies in the Center for Devices and Radiological Health. So FDA officials created an internal Center Science Council that will actively monitor quality and performance, Sebelius said.
"And going forward, we will create a network of experts to help the Center resolve complex scientific issues,"she added. "This will ultimately lead to more timely reviews, especially as we confront new technologies."
Sebelius urged the industry to work with the FDA to secure additional resources—specifically, user fees—to help make the review process more effective.
She highlighted the work of the White House Office of Science and Technology Policy, which she said is working to assemble a team of entrepreneurs to place in residence at the FDA. Sebelius also said the FDA is working with the Medicare and Medicaid programs to establish a process for pre-market evaluations that reduce the time and uncertainty for coverage decisions for these programs, which she said are as essential as getting the products to market.
“So there's plenty of room for improvement, and we are committed to working on new ways to make the review process as consistent and effective as possible,” Sebelius said. “But ultimately, we can't make real progress through changes in policies and processes alone. It will take additional resources, and that means user fees.”
In January, the FDA announced 25 steps it would take this year to improve the predictability, consistency, and transparency of its premarket review programs. As of late September, more than half of those steps have been completed and others are well on their way to implementation, she told medical device executives and industry leaders during plenary luncheon on the closing day of AdvaMed 2011—The MedTech Conference in Washington, D.C.
For example, the FDA recognized the need for greater consistency in the scientific programs and policies in the Center for Devices and Radiological Health. So FDA officials created an internal Center Science Council that will actively monitor quality and performance, Sebelius said.
"And going forward, we will create a network of experts to help the Center resolve complex scientific issues,"she added. "This will ultimately lead to more timely reviews, especially as we confront new technologies."
Sebelius urged the industry to work with the FDA to secure additional resources—specifically, user fees—to help make the review process more effective.
She highlighted the work of the White House Office of Science and Technology Policy, which she said is working to assemble a team of entrepreneurs to place in residence at the FDA. Sebelius also said the FDA is working with the Medicare and Medicaid programs to establish a process for pre-market evaluations that reduce the time and uncertainty for coverage decisions for these programs, which she said are as essential as getting the products to market.
“So there's plenty of room for improvement, and we are committed to working on new ways to make the review process as consistent and effective as possible,” Sebelius said. “But ultimately, we can't make real progress through changes in policies and processes alone. It will take additional resources, and that means user fees.”