White House Science Council Pushes for Faster Drug Approvals

Recommends doubling output of critical new medicines during the next 15 years

Published: Tuesday, October 16, 2012 - 16:49

There are two things right now that get relatively bipartisan support in Washington, D.C. The first is that a major league baseball team in D.C. won a pennant for the first time since we stopped huddling around our radios for entertainment. [Editor’s note: The Nationals lost in the first round of the playoffs. Sorry, Michael.] The second item is more up our alley: Americans should not be the victims of drug shortages, and something needs to be done about it.

Help may be on the way: A Sept. 25, 2012, report from the President’s Council of Advisors on Science and Technology (PCAST) makes it clear that the council wants the U.S. Food and Drug Administration (FDA) to expand its use of faster drug approvals to a wider range of diseases. For starters, the advisors called for the agency to speed approval for drugs aimed at “special medical use” areas such as obesity.

The report calls for the United States to set a goal of doubling the output of innovative new medicines that meet critical public health needs during the next 10 to 15 years, while continuing to increase drug safety.

To support innovation and accelerate the development of new therapies, the report makes a number of detailed recommendations aimed at bolstering the discovery and development of new therapeutic compounds; optimizing processes used by the FDA to evaluate the safety and efficacy of candidate drugs; enhancing long-term monitoring of approved medicines; and enhancing public understanding about the benefits and risks of medicines.

“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,” says Eric Lander, who co-chairs PCAST.

Interestingly, the report says the rate of new-drug applications submitted by industry to the FDA, as well as new drug approvals, has remained relatively constant for 20 years. In an encouraging sign, however, the FDA approved 35 new medicines in the past year—among the highest totals in the past decade.

The report concludes there are two critical needs related to drug discovery and development that must be addressed to advance innovation:
1. Scientists need better methodologies and tools for translating basic biological insights into validated therapeutic targets and leads—a gap in the drug discovery and development pipeline that academic scientists often view as “too applied” and pharmaceutical companies often eschew as “too basic” to justify private investment.
2. Pharmaceutical developers and regulators need to incorporate new efficiencies into clinical trials of candidate medicines—complex and costly human studies that today constitute fully 40 percent of the biopharmaceutical industry’s R&D budget.

To achieve some of the report’s broader goals, PCAST recommends the creation of a public-private “Partnership to Accelerate Therapeutics,” involving representatives from the biopharmaceutical industry; the academic biomedical research and ethics community; physician societies and pharmacists; patient-focused research foundations and advocacy groups; healthcare providers and insurers; and the federal government.

The partnership would help identify and plan collaborative actions to speed drug development while balancing competing stakeholder interests and minimizing duplication of efforts.

Sure, it sounds a little idealistic and even a tad naive. But then again, few back in April were picking the Washington Nationals to win the NL East title in October.

You could look it up.

This article was first published Oct. 16, 2012, on the AssurX website.

About The Author

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.