Industry and patient representatives embraced the sixth version of the Prescription Drug User Fee Act, aka PDUFA, while consumer groups balked at the unabashed enthusiasm shown by their counterparts at a public meeting held by the FDA on Monday.
As Marc Boutin, JD, CEO of the National Health Council, a patient advocacy group, expressed gratitude for the inclusion of the patient voice in the FDA’s commitment letter, so that “not a single company is going to develop a product without engaging the end user (the patient) throughout that development,” Paul Brown, government relations manager for the National Center for Health Research, leveled a long-standing objection: “User fees should focus more on the safety and efficacy of drugs, not just the speed of approval,” he said.
He also cautioned the agency against treating industry as “a customer it needs to please.” Brown and Boutin spoke at a public meeting convened to solicit feedback from stakeholders regarding the payments made by drug and device manufacturers for human drug reviews. The latest reauthorization, if it passes, will determine the agency’s user fee policies from 2018 to 2022.
Brown described the tenor of the meeting as “almost like puppy dogs and rainbows.” […]
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