FDA Releases Report on Challenge and Opportunity to Developing New Medical Products - March 18, 2004

The US Food and Drug Administration (FDA) recently issued a report entitled “Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products” . According to the FDA’s press release, the report “particularly focuses on the unique opportunities for FDA to collaborate with academic researchers, product developers, patient groups, and other stakeholders to make the critical path much faster, predictable, and less costly” (http://www.fda.gov/bbs/topics/news/2004/NEW01035.html).

The Wall Street Journal (3/16/2004) also notes that “In measuring effectiveness of drugs, the FDA report says there’s a need for helpful tools such as ‘surrogate markers,’ used to predict the effectiveness of a drug in a trial. The agency also points to several specific areas where new research could help develop technologies that could be used for drug development, including imaging techniques.”

Indeed, the FDA reports that “Adoption of a new biomarker or surrogate endpoint for effectiveness standards can drive rapid clinical development” (p. 21). The report also states “Imaging technologies, such as molecular imaging tools in neuropsychiatric diseases or as measures of drug absorption and distribution, may provide powerful insights into the distribution, binding, and other biological effects of pharmaceuticals, but their predictive value needs further study and evaluation” (p. 24).