Food and Drug Administration head Dr. Margaret Hamburg said her agency, which determines the safety of everything from baby food to medical devices, is in need of a scientific overhaul in order to keep up with innovation.
In a speech at the National Press Club in Washington, D.C., Hamburg said the watchdog agency is relying on “20th century approaches to 21st century therapies” and urged Congress to increase the agency’s funding in the future to keep up with new scientific discoveries.
Today the federal watchdog agency also released a report, ” Advancing Regulatory Science for Public Health,” outlining a series of initiatives it’s undertaking in order to achieve the commissioner’s goals.
Many of the proposed changes already been made public, this summer when the FDA released recommendations from an internal report on the 510(k) clearance process, and in its $4.03 billion FY 2011 budget request to Congress — when it earmarked $25 million for advancing regulatory science.
Specifically, the agency will look to make substantial investments in accelerating the delivery of new medical treatments including stem cell-based therapies, personalized medicine, safer pain medications and an emphasis on applying regulatory science to “modernize the understanding and control of medical product manufacturing process.”
The agency said the “Quality by Design” of the initiative would ultimately lead to lower development and manufacturing costs for drugs, devices and biotechnology.
Points of emphasis include:
- “Continuous processing, in which materials constantly flow in and out of the equipment and reduce overall manufacturing time and cost;”
- “The use of process analytical technology (PAT) to monitor and control manufacturing processes as opposed to just testing products;”
- “New statistical approaches to detect changes in process or product quality.”
The agency’s report also highlighted several partnerships created to help further regulatory science:
- A Joint Leadership Council recently created by FDA and NIH to promote the expansion of regulatory science
- The creation and support of academic “Centers of Excellence in Regulatory Science,” to carry out applied regulatory science research both independently and in collaboration with the FDA
- Enhanced strategic collaboration and coordination with other governmental agencies to develop new programs to advance regulatory science and innovation
- Enhanced support and focus for the “Critical Path Initiative” to catalyze and enable partnerships and consortia that advance regulatory science and public health through innovation and modernization of the medical product development and evaluation process
Partnership with the Reagan-Udall Foundation on projects in support of regulatory science
Hamburg also stressed the importance of continued increases in funding to the FDA.
“There is no other agency in government that does what we do,” Hamburg told reporters. “If we can’t do our job and do it well, there’s no one there to backstop us.”
A full copy of the report is available on the agency’s website.
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