Skip to content

Regulatory Science: A Biodefense Backlash?

Regulatory Science: A Biodefense Backlash?

By Michael McCaughan,

Getting money for “Regulatory Science” is a key priority for FDA under Commissioner Hamburg

. Her background in biodefense helped shake loose some money—but keeping it will rely on appeasing appropriators on the Hill.

Securing funding for “Regulatory Science” has been a top priority for Commissioner Margaret Hamburg, highlighted most recently during an October 6 luncheon address to the National Press Club, coinciding with a white paper outlining the agency’s vision for enhancing its science base. 

The initiative may be the last hope for the agency to play a central role in encouraging drug development as a core part of its mission, after the underwhelming results from prior efforts like the Critical Path Initiative and the Reagan/Udall Foundation. For industry, “Regulatory Science” funding may be the only hope to secure a pool of resources for the agency to craft policy in areas like companion diagnostics, surrogate markers, etc. without another significant step-up in user fees.

During her press club address, Hamburg noted that regulatory science wasn’t necessarily a topic she saw as a priority before joining FDA, but she quickly found a way to bring one element of her background—a focus on biodefense issues at the Institute of Medicine—to the cause.

When HHS released its strategic plan for countermeasure development in August, it included a plan to “re-allocate” $170 million in pandemic flu preparedness to support regulatory science, the theory being that it would help the agency appropriately regulate biodefense agents. (Read more here.)

That, as Hamburg noted October 6, is by far the largest amount ever devoted to support regulatory science at FDA.

But there is a downside to “re-allocating” funds: appropriators don’t like to see their earmarks redirected. And that may have consequences for FDA.

During a September 29 hearing on the countermeasures plan, Senate Labor/HHS Approps Chair Tom Harkin (also chair of the Health Committee) heard testimony for several witnesses all emphasizing the need to provide support for FDA as part of the biodefense initiative.

As the hearing wound down, Harkin made clear that he doesn’t necessarily see things that way.

“I think sometimes we rely too much on the FDA,” Harkin said. He emphasized that he didn’t mean FDA couldn’t do important work, just that Congress keeps piling it on. “We are about to pass a new food safety bill,” Harkin noted, but “we are not going to give them the funds and the personnel” to do everything the bill requires.

“FDA has so much on their plate that they really can’t give [countermeasure development] the kind of focus that it should,” Harkin declared.

Stressing that he was “just thinking out loud,” Harkin suggested that maybe “we need to take something out of FDA, something out of Defense, that would be put under BARDA, and let BARDA be the lead agency.” (Harkin previously noted the “hard work” he and others in Congress put into creating BARDA, and wondered how the new HHS initiative fit within that framework.)

Harkin noted his ongoing frustration with the failure to achieve licensure of cell-based flu vaccines. “FDA just—institutionally, I don’t know if they can do it,” he said. “It is just that they have so much to do and they have other responsibilities, and mostly they are focused on drugs that we take for illnesses.”

“This is not the biggest thing on their plate,” Harkin added. “But in terms of the country itself, this is probably one of the biggest things we’ve got confronting us right now.”

Alliance for Biosecurity witness Eric Rose (CEO of Siga Technologies) agreed with Harkin that the issue facing FDA isn’t just resources. “The proposal that HHS is making now is a very substantive and important proposal,” he said. “This whole issue of regulatory science is important, but there is also an issue of regulatory culture.”

“We come at this from different perspectives,” Harkin cut in. “You want to change the culture at FDA,” but, Harkin said, “I am not certain we can do that.”

Rose responded that he had suggested a separate center for Biodefense during an IoM meeting earlier in the year, but that the proposal didn’t make it very far. “Now that is a good idea,” Harkin replied. “Get me some stuff on that, will you?”

The other two witnesses quickly chimed in their support for leaving regulation of biodefense agents in the hands of FDA.

While “you can’t have the same people evaluating a drug for high blood pressue that you have looking at an agent for biodefense,” Infectious Diseases Society of America witness Andrew Pavia said, “we need professionals to look at the safety and efficacy.”

“I think it can be done within FDA but not within the current structure, and I think Dr. Hamburg has some very good ideas for redoing this, but it may require some statutory and legislative changes to let them do that and apply appropriate standards.”

As for changing the culture at FDA, “leadership is one way to do that,” said WMD Center CEO Randall Larsen. “I have great confidence in Peggy Hamburg.”

Will Harkin develop that same level of confidence? The future of regulatory science may defend on that answer.