It seems that most new proposals for improving public health and the nation's economy offer ways to reduce the cost and time
of drug development and thus speed more new products to patients. This is particularly evident in the rash of "pro-innovative"
approaches for testing and regulating medical products proposed as add-ons to Food and Drug Administration (FDA) user fee
legislation moving forward on Capitol Hill.
Typical of the broader look, the "Bioeconomy Blueprint" issued by the White House Office of Science and Technology Policy
in April maps out how biotechnological advances can promote economic growth, create new jobs, and improve health. A strong
undercurrent in this grab bag of ideas is that innovation will flourish by eliminating unnecessary regulatory roadblocks.
Thus it supports revisions in rules governing human subject research and proposes to tap into FDA's vast repository of drug
safety and efficacy data to speed drug development.
New drugs from old
The Blueprint also backs public-private partnerships supporting translational research by the National Institutes of Health
(NIH) to find new ways to prevent and cure disease. Such an initiative was launched last month by Health and Human Services
Secretary Kathleen Sebelius, who joined NIH Director Francis Collins and three pharma companies to announce a pilot that would
"rescue" compounds abandoned by industry. Pfizer, AstraZeneca, and Eli Lilly agreed to launch the program by working with
researchers on "repurposing" drugs sitting on their shelves.
The initiative will start with the new National Center for Advancing Translational Sciences (NCATS) funding $20 million in
grants next year to support promising research proposals, along with templates for agreements on dealing with intellectual
property. The companies will provide researchers with the compounds and relevant data, while retaining rights to their products.
Scientists from academia, non-profits, or biotech companies will be able to publish study results and negotiate licenses on
new discoveries. The program intentionally ruled out seeking additional uses for approved drugs, as those raise more complex
IP issues. NIH is soliciting comments on the templates, which are key to speeding up negotiations among all parties and making
the program work. A list of compounds available for research will be published in a few months, and initial grants awarded
The manufacturers see the NIH program as a way to extend similar arrangements they already have with individual research institutes,
including AstraZeneca's partnership with the United Kingdom's Medical Research Program. The selected compounds have been tested
for safety in early clinical trials, but lacked sufficiently robust results to support larger studies. The hope is that these
abandoned products will do better with new targets and new indications.