Rowing with One Arm
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.
One of Commissioner Margaret Hamburg's key goals is to increase the intellectual and financial investment in regulatory science - which can be defined as scientific findings that have been validated sufficiently for FDA to use them to make decisions with public health consequences.
Bolstering regulatory science would allow FDA to set review standards, issue guidances, and adopt more predictable decision-making procedures.
Experience with FDA's Critical Path initiative, which never attracted champions on Capitol Hill and thus has been woefully underfunded, suggests that success in strengthening the agency's scientific capabilities, and infusing a higher level of scientific rigor into its operations, is contingent on Hamburg's effectiveness in persuading colleagues in the Obama administration, members of Congress and regulated industry, of the urgency of the task, and explaining precisely what FDA intends to do, as well as how progress will be measured.
It also will be necessary to make clear what resources are needed, to persuade the administration to ask Congress for them, and then cajole Congress into providing them.
So far, Hamburg has focused primarily on the first step: explaining the need.
She has framed the issue in language that should mean something to people in the White House and on Capitol Hill who have fought for hundreds of billions of dollars for biomedical research in the expectation that it will lead to cures and therapies.
In interviews with BioCentury, and in several public speeches, Hamburg has compared American investment in biomedical innovation to a rower whose right arm is heavily muscled, built up through NIH's and industry's vigorous