The fact-finding phase is over. At the September 10th 21st Century Cures Initiative roundtable, E&C Chairman Fred Upton (R/MI), said that committee staff will now begin developing draft legislation. “We intend to release a Cures legislative discussion draft in early January 2015 and will look to swiftly move the legislation early in the next Congress.”
But, per Ranking Committee Member Henry Waxman (D/CA), “If we come in with a blunt instrument, suddenly recreating the FDA authorities or mandating things for FDA or … the Department of Health and Human Services to do things they are not equipped to do – and that we of course don’t fund them to do – I think we have to be cautious about some the legislation that may be proposed.”
Waxman’s fear of unintended consequences may seem unusual for someone who often advocates for an active government role in addressing societal problems, but he noted that one of the major reforms at FDA in recent decades, the creation of accelerated approval, was spurred on by AIDS activists, and not by legislation. “The people that brought home the reform at FDA, that got some of these therapies out quickly, were the ACT UP group and the gay community,” he said. “They studied the law of FDA and argued, ‘You don’t need to take so long, you don’t have to weight to the end result to show that the therapy is safe and effective, you can have markers to get these products out more quickly.’”
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