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Long-Stalled FDA Reform Sits On Senate’s Lame-Duck Calendar

The U.S. Capitol (iStock)

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.

“Let’s do it now,” said Marc Boutin, CEO of the National Health Council, a nonprofit 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.”

The Obama administration had previously been supportive of lawmakers’ work, as long as the final package were to include funding for its “cancer moonshot” and Precision Medicine Initiative. The White House Tuesday declined to comment on the legislation’s current progress.

Some congressional leaders say the legislation is an opportunity for Republicans and Democrats to show they can work together after a divisive election. Senate Majority Leader Mitch McConnell, R-Ky., and House Speaker Paul 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.

But Sen. Patty Murray, D-Wash., the committee’s ranking member, and other Democrats are pushing for even broader legislation. They would include more funding for opioid addiction treatment under a law passed in July and mental health reform approved in the House and by the HELP committee but not yet taken up by the full Senate.

Both could complicate agreement on FDA changes and NIH funding, essentially making the bill into an omnibus health care measure. Paying for the legislation remains an issue; the House would fund it partly by selling oil from the nation’s Strategic Petroleum Reserve. Republicans in the past have insisted that the final package’s cost be fully offset and subject to annual appropriations. Democrats have balked at that and argued for a firmer long-term funding commitment.

Meanwhile, some Senate Democrats have also reportedly asked for a larger increase in FDA resources than the House bill proposes, arguing that $550 million over five years is not enough to cover the agency’s greater responsibilities.

The intricacies of drug and device development and regulation make the legislation necessary, its proponents say. Drugs can take years to come to market in large part because pharmaceutical companies must conduct detailed studies of their effectiveness and safety in patients. While that system would be preserved, the bills would clear the FDA for considering less burdensome criteria to approve drugs that show special promise.

The path also would be made easier for new indications of previously approved drugs. The agency would be able to use evidence from doctors’ clinical experience, for instance, along with less detailed studies.

But opponents contend the legislation could result in drugs and devices reaching the market without thorough evaluations. And they are concerned that the House bill gives some brand-name drugs longer periods of market exclusivity, thus slowing the availability of less expensive generic drugs and, as one consumer coalition asserted, denying “patients access to affordable, life-saving medicines.”

Sarah Sorscher, an attorney at Public Citizen’s Health Research Group, said that although the watchdog organization supports additional NIH funding, “the Cures Act raises the risk that bad products will come to market and patients will be harmed.”

Opponents also want Congress to hold off on the legislation until next year so that lawmakers can simultaneously debate and address ways to fight rising drug prices.

“It is critical that any legislation making changes to drug policies take steps to rein in the cost of prescription drugs,” the AFL-CIO, Alliance for Retired Americans and Consumers Union wrote in an Oct. 26 letter to the Senate and House Democratic leaders.

In a strange-bedfellows scenario, the groups may have a possible ally in President-elect Donald Trump. Trump’s website lists FDA reform as a priority, and according to statements he made on the campaign trail, he supports curtailing drug prices, possibly through government negotiation with the pharmaceutical industry.

The National Health Council’s Boutin said waiting until 2017 could risk progress made to date on the bills, after two years. “Adding the drug price issue to deliberations is not going to be productive,” he said. “We support addressing that in the future but not in the context of this legislation now.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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