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

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.