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Long-Stalled 21st Century Cures Act Sits on Senate’s Lame-Duck Calendar

Capitol Dome HEALTHCAREWashington, DC, November 24, 2016 — Steven Findlay reports in The Washington Post that Republicans in Congress are pushing to pass long-stalled legislation by December that gives the Food and Drug Administration (FDA) new powers to more rapidly approve drugs and medical devices.

Over five years, the complex legislation would include $550 million in additional funding for the agency, plus upward of $1 billion annually in added spending for the National Institutes of Health.

The bills have had bipartisan support in Congress during the past two years.

They’re backed by the pharmaceutical and device industries as well as hundreds of patient-support groups, academic institutions and medical schools.

This “is a once-in-a-generation opportunity to change the way we view and treat disease,” said Rep. Fred Upton (R-Mich.), who has been a key advocate on Capitol Hill.  “Patients can’t wait any longer. It’s time to deliver.”

While legislative wrangling and consumer and public health groups’ concerns over safety standards could thwart the effort, congressional staffers report steady progress over the past week.

The House is further along, having passed its 350-page 21st Century Cures Act in July 2015.

The Senate’s version is 19 separate bills that were approved in committee this past spring but never voted on by the full Senate. Congressional staffers said Tuesday that a House-Senate compromise bill could emerge from ongoing negotiations and be voted on soon by both chambers.

Backers say the measures would speed the FDA’s approval process by allowing it more flexibility in evaluating the effectiveness and safety of drugs and devices.

The increased funding would enable the agency to hire additional staff at salaries competitive with the private sector and academia — an issue that has vexed the FDA for years.

The agency has more than 700 vacancies in the division that approves new drugs, for example.

For Findlay’s full story, click here.