STUDY: MORE FDA-INDUSTRY MEETINGS COULD SPEED UP DRUG APPROVAL PROCESS
Additional meetings between the FDA and drug manufacturers could help accelerate the drug approval process, says a new study commissioned by the agency. FDA officials, while lauding the study's conclusions, argue additional resources are needed to conduct more meetings with industry.
According to the report, new drug and biologics applications were more likely to be approved the first time around when product sponsors met with the FDA before the final phase of human testing. Sponsors meeting with the agency before the final phase had an approval rate of 52 percent in the first review cycle as opposed to 29 percent for sponsors who did not have these meetings, states the report released recently by the FDA.
In addition, almost half of the sponsors who meet with the agency before their applications were submitted had first cycle approvals, says the report, "Independent Evaluation of FDA's First Cycle Review Performance -- Retrospective Analysis," which was conducted by Booz Allen Hamilton.
The agency must be more involved with sponsors early on to ensure higher first-cycle approval rates, said the report, which urged the FDA to play a "much more proactive role" throughout the development process. Doing so will help the agency better identify and communicate potential problems with an application earlier on, the report concluded.
Acting FDA Commissioner Andrew von Eschenbach said these meetings, also known as milestone meetings, were integral to getting drugs approved more quickly. "These meetings have become one of the most valuable aspects of the drug development process," he said.
But the agency will not be able to ramp up the number of meetings without additional resources, Eschenbach added. Milestone meetings are "very labor intensive and require adequate agency resources in order to sustain the current success," he said.
The Booz Allen study examined all new molecular entity applications submitted between Fiscal 2002 and 2004 that had reached first action by December 1, 2004. The focus is on the management and procedures for FDA product reviews and is not intended to evaluate the merit of the underlying science or quality of discipline reviews, the report said. The report is at http://www.fda.gov/OHRMS/DOCKETS/98fr/oc05257-rpt0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/oc05257-rpt0001.pdf).