The House Energy & Commerce Committee this week is expected to unveil a revised version of controversial legislation overhauling the Food and Drug Administration's regulatory process, with a hearing scheduled for Thursday. But as of late last week, there were still unresolved issues.
The 21st Century Cures Act, supported by the drug and device industries, would make sweeping changes in the regulation of drugs, devices, health information technology and telehealth. Backers say its provisions would accelerate review of new products, make promising medications and devices available to the public faster, and significantly cut costs associated with product development.
But Dr. Margaret Hamburg, who recently stepped down as the FDA's commissioner, called the effort to speed up the drug development process “a terrible mistake” that could harm patients and drugmakers.
An earlier draft of the legislation from House Republicans prompted Democrats to withdraw their support. Rep. Frank Pallone (D-N.J.), the committee's ranking Democrat, cited a lack of funding for the National Institutes of Health.
Since then, Democrats have sought to incorporate a big bump in NIH funding. Former Republican House Speaker Newt Gingrich last week urged doubling the NIH's budget.
Meanwhile, critics have attacked the bill's provisions to extend market exclusivity periods for some drugs, which could drive up costs. Leigh Purvis, director of health services research in AARP's Public Policy Institute, also criticized a provision that would push the FDA to approve more off-label drug uses. “A lot of what they're doing is what I call legislating science,” she said. Still, she was optimistic the final bill would be improved.