FDA Reports on Advancing Regulatory Science

Oct 13, 2010

The US Food and Drug Administration released an implementation report on its Regulatory Science Initiative. The report outlines the agency’s plans to advance regulatory science through new tools, standards, and approaches for assessing the safety, efficacy, quality, and performance of FDA-regulated products, according to an agency press release.

Last February, FDA launched the Regulatory Science Initiative to fast-track drug product  innovations to the public. The strategy builds upon the agency’s Critical Path Initiative (See back story, “FDA and NIH Collaborate to Speed the Introduction of New Medicines”). 

Included in the new report are examples of FDA activities in regulatory science as well as recommendations for helping to deliver better and safer products to the market. The following seven public-health areas are addressed:

  1. Accelerating the delivery of new medical treatments to patients 
  2. Improving pediatric and child health 
  3. Protecting against emerging infectious diseases and terrorism 
  4. Enhancing safety and health through informatics 
  5. Protecting the food supply 
  6. Modernizing safety testing 
  7. Meeting the challenges for regulating tobacco

For scientific advances to reach their full potential, FDA “must play an increasingly integral role as an agency not just dedicated to ensuring safe and effective products, but also to promote public health and participate more actively in the scientific-research enterprise directed towards new treatments and interventions,” according to the report’s executive summary.  “We must also modernize our evaluation and approval processes to ensure that innovative products reach the patients who need them, when they need them.”

The initiative, based on President Obama’s $25-million budget request for fiscal year 2011, includes a new office of regulatory science within FDA, and focuses on the following:

  • Leadership, coordination, strategic planning, and transparency to support science and innovation
  • Support for mission-critical applied research, both at FDA and collaboratively
  • Support for scientific excellence, professional development and a learning organization
  • Recruitment and retention of outstanding scientists.

In FY2011, according to the report, the agency will support research in transforming product development for patients (e.g., methods for modernizing toxicology, biomarkers, stem-cell initiatives, and drug-review standard updates), science to address emerging technologies in FDA-regulated products (e.g., nanotechnology and new animal biotechnology products), information sciences for health outcomes (e.g., a medical device registry), addressing unmet public health needs
(e.g., nutrition).

FY2011 activities will also work toward the opening of a network of Centers of Excellence in Regulatory Science “to be integrated with expanded intramural FDA research and with other clinical research networks,” says the summary.

FDA Commissioner Margaret Hamburg discussed the initiative at the National Press Club last week.