Regulators must catch up with medical science, says FDA
pharmafile | November 2, 2010 | News story | Research and Development, Sales and Marketing | Advancing Regulatory Science, Critical Path Initiative’, Dr Margaret Hamburg, FDA, regulatory affairs
The head of the FDA has declared a need for ‘regulatory science’ to catch up with the advances in medical research in order to help deliver advances for patients.
The FDA’s new Advancing Regulatory Science initiative was launched in early October, and is a new blueprint which aims to overcome obstacles to new medical break-throughs.
FDA commissioner Dr Margaret Hamburg launched the new initiative at a US national Press Club event, admitting that regulatory science was not as robust as it should be.
“To put it simply, there is a troubling gap between advances in science and available patient care,” Dr Hamburg said. “We need to build a bridge across this gap, and that bridge, in my view, is regulatory science.
“We cannot take advantage of the breakneck speed of biomedical research unless we also emphasise innovation in regulatory science. Just as biomedical research has evolved over the past few decades, regulatory science must also evolve in important and powerful ways.”
She added that regulatory science had been ‘underappreciated, and underfunded’ for some time.
“We are left relying on 20th century approaches for the review, approval and oversight of the treatments of the 21st century. So now is the time to move forward.”
Hamburg stressed that external partnerships will be the focus, particularly with academic centres.
She said new pilots and feasibility studies would be launched to investigate methods of eliminating potentially harmful drugs earlier, and the verifying of promising and safe candidates faster, and more reliably.
This would include measures such as using advanced genetic data and biomarkers to find faster paths to disease targets, and supporting efforts to optimise clinical trials design.
A key part of the plan is to set-up centres of excellence in regulatory science, which would most likely be housed in academic centres, and would bringing academia, FDA and industry together in collaboration.
The FDA’s ‘Critical Path Initiative’ is an existing project which has similar objectives, but the regulator says the new programme will go further. It will be supported by a four part framework:
• Leadership, co-ordination, strategic planning and transparency to support science and innovation
• Support for mission-critical applied research, both at the FDA and collaboratively
• Support for scientific excellence, professional development and a learning organisation
• Recruitment and retention of outstanding scientists.
The agency hopes to secure a $25 million budget for the next financial year 2011 in order to expand partnerships with academia, industry and government around the country.
A new office dedicated to regulatory science will lead strategic development and co-ordination within FDA, and early efforts will focus on recruiting key personnel and building senior leadership.
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