Lagging FDA Human Research Rules Draw Cures Law Architects’ Ire

Architects of the updated biomedical innovation law have a question for newly-installed FDA head Stephen Hahn: What’s taking so long updating the agency’s protections for research study participants?

The Food and Drug Administration had until Dec. 13 to take steps to make sure its human research study protection rules work in concert with those overseen by the Department of Health and Human Services Office for Human Research Protections, known as the Common Rule. However, it doesn’t appear that the agency will hit that deadline.

So Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.), who are in the early stages of crafting a follow to the 21st Century Cures law, want to know why the FDA hasn’t yet completed the steps required by that 2016 law.

Navigating the parallel and sometimes conflicting sets of rules complicates research into new drugs and medical devices—especially when studies are subject to both sets of rules. The required updates under 21st Century Cures were intended to smooth oversight of research testing medical products on humans.

“Ensuring that the FDA is working to meet all of its requirements under the Cures Act remains one of our top priorities,” DeGette told Bloomberg Law in a statement before the Senate confirmed Hahn Dec. 12.

She and Upton will meet with Hahn “as soon as he is confirmed by the Senate to discuss what the agency is doing to fulfill its obligations under the bill.”

FDA Rules Lagging

The FDA regulations and the Common Rule were once quite similar. But amid the process of enacting Cures, the Common Rule underwent a massive rewrite, and those changes largely went into effect this past January. Some of those changes include eliminating an annual check-up known as a continuing review for some low-risk studies and requiring that informed consent documents list all key information at the top of the form. The FDA has said it will harmonize its regulations with the new Common Rule, but so far it hasn’t caught up.

The FDA said in a statement that it’s taken a number of actions toward harmonizing—to the extent practicable and consistent with other laws—its human subject regulations with the HHS’s Common Rule. An OHRP spokesperson said the HHS agency had nothing to add beyond the FDA’s response.

The FDA has issued guidance allowing institutional review boards—ethics panels designed to protect human research subjects—to waive informed consent requirements for minimal risk studies for the first time and outlining what it expects for clinical research that is subject to both the FDA’s human subject protection regulations and the Common Rule. However, the agency has not completed any rulemaking as required by Congress.

The FDA’s regulatory to-do list for the fall included several new items related to its efforts to update its human subject protection regulations so they line up with the Common Rule overhaul. But the proposed rules still aren’t out, and the FDA declined to provide further comment on the status of the proposals.

Ironing Out Differences

While the FDA’s guidance did help streamline oversight for researchers, more work needs to be done to achieve the 21st Century Cures law’s goals, David Peloquin, a research attorney with Ropes & Gray LLP in Boston, told Bloomberg Law.

“But the remaining differences mean that institutions still face different requirements for Common Rule-regulated research and another for FDA-regulated research with respect to certain topics like expedited review procedures and IRB continuing review requirements,” he said.

For example, the FDA and the Common Rule differ on which types of ethics reviews for low-risk studies can be fast-tracked through the IRB, known as expedited review. The FDA standards require an annual checkup for some low-risk studies while the Common Rule has eliminated that step entirely.

DeGette said that outstanding work will factor into planned updates to the 21st Century Cures law.

“And, as we work to develop Cures 2.0, one of the things we’ll be looking at is how we can ensure that our federal agencies are taking the steps necessary to implement the legislation in the timeframe that Congress mandates,” she said.