A deal aimed at allowing the Food and Drug Administration to collect $400 million-plus annually in additional user fees could speed up pharmaceutical and device approvals, according to industry experts.
A bipartisan group of congressional leaders this month released a draft of the FDA Reauthorization Act, which would continue the FDA's authority to collect user fees from the makers of branded and generic prescription drugs, medical devices and biosimilars.
While the funds raised under the proposed reauthorization would allow the FDA to hire more staff and accelerate approvals, critics claim that the rising fees disproportionately harm smaller companies that cannot accommodate the fee hike.
Greg Cauchon, a former research scientist at Amgen who now runs the biotech incubator Ventura BioCenter, would rather see the user fees removed to create a level playing field, he said.
The fees “merely act to entrench the larger firms at the expense of smaller ones while providing the paying companies with undue regulatory influence,” Cauchon said. “If regulating the nation's drug supply is important enough for the federal government to do it, they should be able to fund it properly.”