One more vote

How 21st Century Cures Act paves a path for real but modest regulatory innovation

Last week’s vote by the House of Representatives to pass the 21st Century Cures Act sets the stage for a Senate stamp of approval in the coming week, potentially making it the last major piece of legislation President Barack Obama will sign. If a handful of opponents manage to scuttle the Senate vote - which isn’t likely - all the provisions related to FDA and drug development will be reconsidered next year for inclusion in legislation accompanying user fee reauthorization bills.

The final version of the Cures bill is the result of the formula BioCentury posited in March 2015: “Start with a large number of policy options, subtract any that don’t appeal to Republicans, remove any that Democrats adamantly oppose, delete any that industry hates, and kill or revamp those that FDA says it cannot live with.”

The political process has created a consensus bill that lacks the kind of paradigm-shifting changes its authors promised. But Cures would produce real, though modest, forward motion in several areas that are important for translating scientific advances into new therapies.

Some of the most important provisions have attracted little attention. These are tweaks to the law that would allow FDA to pay salaries competitive with those in the private sector. Doing so is essential to close a compensation gap that has made it difficult to recruit and retain enough qualified staff to accomplish its core missions and implement regulatory innovations.

Cures would produce real, though modest, forward motion in several areas that are important for translating scientific advances into new therapies.

Other public health wins include the creation of a new approval pathway that would facilitate the development of antimicrobials to treat emerging and antibiotic-resistant pathogens, as well as creation of a new pathway for qualifying drug development tools such as biomarkers. Cures also would accelerate the integration of real-world evidence into drug reviews (see “Regulatory Innovation.”)

The bill also would reduce some impediments to drug companies discussing pharmacoeconomic data with payers and formulary committees, which could remove one set of barriers to value-based pricing.

Although the law will not come close to meeting the expectations of its supporters, especially patient groups that are touting the legislation as a tool that will create new cures almost overnight, it would provide

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