Long-stalled FDA reform sits on Senate’s lame-duck calendar – Washington Post

 In Health
Republicans in Congress are pushing to pass long-stalled legislation by December 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, 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.

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.

“Let’s do it now,” said Marc Boutin, chief executive of the National Health Council, a nonprofit group that represents about 50 patient-support and disease organizations and gets funding from drug and device companies. “This legislation will enhance research, speed cures to market and benefit public health.”

But the cautionary voices worry about safeguards. This 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 Obama administration had been supportive of lawmakers’ work, as long as the final package contained funding for its “cancer moonshot” and Precision Medicine Initiative. The White House yesterday declined to comment on the legislation’s current progress.

Some congressional leaders say the legislation is an opportunity for Republicans and Democrats to show that they can work together after a divisive election. Senate Majority Leader Mitch McConnell (R-Ky.) and House Speaker Paul D. Ryan (R-Wis.) said earlier this month that the measures are a priority during the lame-duck session.

“Congress should not squander this rare opportunity to get a result on behalf of millions of patients who are waiting for us to deliver on the promise of 21st Century Cures,” Sen. Lamar Alexander (R-Tenn.) said in a statement. Alexander chairs the Health, Education, Labor & Pensions (HELP) Committee and has led the Senate’s supporters.

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