Forget fast tracks and accelerated approvals. A group of distinguished scientists has mapped out a whole new approach to dramatically speed up drug development. And they say their clinical road map will allow the FDA to double the number of new drug approvals it makes each year.
The group of scientists in the President's Council of Advisors on Science and Technology say that a "special medical use" approval could be designated for certain drugs that apply to narrow and carefully defined groups of patients. That way, a relatively small group of high-risk obese patients, for example, could be allowed access to new drugs, shifting the whole risk/benefit paradigm in such a way that the agency could allow for more risk so long as the potential payoff in health benefits was greater as well.
The group is a bit hazy on the details for improving on a system that creates just 30-some new drug approvals a year, a rate that just about everyone in the drug development industry would lament as far too low, especially when you consider the tens of billions of dollars that goes into R&D work. The group wants better translational tools to move development along. And they also want some federal help to bolster developers tackling new programs that are unlikely to offer big returns--like antibiotics.
The key next step, they add, would be a public/private partnership bringing together industry leaders, academics, patient groups, insurers and the feds which could hammer out the specific methods needed to bring this all about over the next few years.
"With improved collaboration among all the participants in the drug development ecosystem and optimization of drug-evaluation pathways, American researchers and companies should be able to accelerate the development of safe and effective drugs while also strengthening the U.S. economy," said Eric Lander, who co-chairs PCAST, in a statement.
Lander is director of the MIT-Harvard Broad Institute, one of a number of scientific luminaries on the White House panel. Of course, big federal advisory panels in general are known for ambitious thinking and weak results. Making this report something more relevant than the other plans now gathering dust won't be easy.
- here's the press release
- and the story from The Wall Street Journal