BioCentury
ARTICLE | Regulation

Rowing with One Arm

December 21, 2009 8:00 AM UTC

Industry and a parade of FDA commissioners have talked for years about the need to upgrade the agency's ability to apply modern science to its regulatory actions. If done correctly, this would shorten the time required for preclinical and clinical development, making the process more predicable and less expensive, while simultaneously improving safety and efficacy.

Increasing FDA's science quotient is not a controversial goal, but it has not been easy to achieve. And while Congress has been generous with funding for NIH at the front end of the drug discovery process, it has been stingy in its financing of FDA at the back end of the process, even though this would undoubtedly result in better translation of discoveries into products with societal benefit...