The Personalized Medicine Coalition (PMC), Washington, DC, has praised the recent FDA user fee legislation passage through Congress noting that its personalized medicine-relevant positions will enhance innovators confidence in the regulatory system and bring more targeted therapies to patients quickly.
"The inclusion of pharmacogenomics and biomarker-developed therapy provisions in this legislation is a sign that Congress recognizes the ability of personalized medicine treatment approaches to improve patient outcomes," said Amy Miller, vice president for public policy at PMC. "We look forward to continuing to work with policymakers to put in place additional incentives for personalized medicine innovation."
The bill reauthorizes user fees that industry will pay to the FDA for the review of new products. Provisions directly related to personalized medicine include:
- The development of FDA’s capacity to review submissions involving pharmacogenomics and biomarkers by integrating and training staff with pharmacogenomics and biomarker expertise into the product review process.
- The creation of an expedited approval process for "breakthrough therapies"–drugs that are both developed using biomarkers and used to treat serious or life-threatening ailments.
- A requirement that the FDA notify Congress 2 months in advance of the agency’s planned release of any guidance or draft guidance document related to the regulation of laboratory-developed tests.
"With the passage of this important bill, policymakers can now turn their attention to other issues surrounding medical innovation, improving patient care, and reducing systemic health care costs," said Edward Abrahams, president of PMC. "Personalized medicine and targeted therapeutics will help us get there."