Long-Stalled FDA Reform Sits on Senate’s Lame-Duck Calendar
This article originally appeared on Kaiser Health News on November 23, 2016.
By Steven Findlay
Republicans in Congress are pushing to pass long-stalled legislation by January that gives the Food and Drug Administration 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, as well as $1.75 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.”
But legislative wrangling and concern among consumer and public health groups could still thwart the effort.
The legislation would “lower safety and approval standards for drugs and medical devices” and should “not be rushed into law in the final brief weeks of this Congress,” one coalition of opponents, which includes Breast Cancer Action and the National Women’s Health Network, said in a Nov. 8 letter to senators.
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. Tuesday congressional staffers reported steady progress and said that a House-Senate compromise bill could emerge from the negotiations, to be voted on by both chambers in coming weeks.
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.
Rigorous standards for drug and device approval and safety would be preserved, proponents insist.
The bills also would give the agency more power to provide newer drugs to terminally ill patients. And they would allow the FDA to create a new approval pathway for antibiotics and economic incentives for developing new antibiotics.