Congress Recognizes Value of Personalized Medicine Approaches in FDA User Fee Authorization Legislation

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Regulatory uncertainty has long been a concern for personalized medicine innovators and the Turning the Tide Against Cancer conference earlier this month reinforced the need for regulatory changes to facilitate personalized medicine.  While that uncertainty is not gone, the Food and Drug Administration (FDA) user fee reauthorization legislation, which passed its last major hurdle through Congress yesterday, contains personalized medicine-relevant policy changes that will enhance the regulatory process for new products.

We applaud Congress for passing this legislation and commend the measures it takes to smooth the way for more personalized medicine 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  • A requirement that the FDA notify Congress two months in advance of the Agency’s planned release of any guidance or draft guidance document related to the regulation of laboratory-developed tests.

We look forward to continuing to work with FDA to improve the complex regulatory process for personalized medicine and accelerate adoption new personalized treatments.

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