White House Science Council Pushes for Faster Drug Approvals
There are approximately two things right now that get relative bipartisan support in Washington, D.C. The first is that a Major League Baseball team in D.C. has won the National League East pennant for the first time since we stopped huddling around our radios for entertainment. 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; one way is through faster drug approvals.
Help may be on the way. A September 25th report from The President’s Council of Advisors on Science and Technology (PCAST). Inside the lengthy PCAST report it is clear the council wants the Food and Drug Administration 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 U.S. to set a goal of doubling the output of innovative new medicines that meet critical public health needs over 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,” said 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 bio- pharmaceutical 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.