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House lawmakers have developed extensive marketing materials for their draft bill.

House lawmakers have developed extensive marketing materials for their draft bill.

U.S. House of Representatives Committee on Energy and Commerce

In the wake of new cures bill, NIH celebrates while FDA mulls responsibilities

A day after the much-heralded rollout of a new draft bill to accelerate biomedical innovation, lawmakers got some feedback from officials at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). In a hearing held by the Health Subcommittee of the U.S. House of Representatives’ Energy and Commerce Committee, much of the buzz centered around a proposal to bump up NIH funding—a dramatic change from a previous version of the bill, known as the 21st Century Cures Act. The new draft recommends $10 billion in extra funding for NIH over 5 years.

The response from Kathy Hudson, NIH’s deputy director for science, outreach, and policy, was straightforward. “Thank you, thank you, thank you, thank you,” she told the committee. “The research community is ecstatic.” She later added that the legislation may mark a transition “from a very dreary phase in biomedical research to a much brighter phase.”

Legislators also discussed the details of the $10 billion, which would be provided through a new NIH innovation fund for three purposes: support for “young emerging scientists,” precision medicine, and a third category still to be determined. Asked to speculate on what that third category should be, Hudson said one priority is simply funding more innovative research that the agency has been unable to fund with its current budget; another would be NIH’s role in the $110 million Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative.

Hudson also welcomed bill language directing NIH to develop an overarching strategic plan—a suggestion that research advocates had criticized in an earlier draft. Indeed, NIH is already working on such a plan, NIH Director Francis Collins said this morning at a separate hearing before a Senate spending panel. The plan “will set the stage for the future of biomedical research,” Collins said. 

After the hearing, Collins explained that the plan, which is already required by a 2015 spending law, will be developed through a process quite different from NIH’s last stab at strategic planning in the early 1990s. That effort involved months of contentious public meetings across the country and produced a document that was ignored. This time, NIH is folding together strategic plans that NIH’s institutes and centers already produce and looking for “overlapping themes that deserve highlighting,” Collins says. NIH hopes to release a draft by August, gather feedback online, and issue the final plan by December. 

House member Andy Harris (R–MD), one of several Republicans who have recently questioned NIH’s funding priorities, praised Collins’s announcement: “Congress needs to know the NIH is wisely spending the money it currently receives,” Harris said in a statement. One biomedical research lobbyist said the new version of the 21st Century Cures bill has eased his group’s concerns about the strategic plan. If the plan is tied to a funding increase for NIH and it “moves the process forward, we’re all for it,” said David Moore of the Association of American Medical Colleges in Washington, D.C.

Resources for FDA?

The bill also lays out extensive new responsibilities for FDA, a new priority review process for antibiotics aimed at limited patient populations, a speedy “breakthrough” approval pathway for medical devices, and more than a dozen new guidance documents to advise drug developers.

But while the bill supports major funding boosts for NIH, it doesn’t make any budget suggestions about FDA. That’s the result of fundamental differences in the way the two agencies are funded, explains Steven Grossman, deputy executive director of the Alliance for a Stronger FDA in Silver Spring, Maryland. Because NIH goes through a triannual reauthorization process, an authorizing committee can recommend a boost to the agency’s spending (although appropriators must approve any extra spending). FDA, meanwhile, has a so-called permanent authorization and relies on user fees from drug developers to fund much of its activity, meaning that there isn’t a similar occasion for lawmakers on authorizing panels to suggest more support.

Still, several lawmakers acknowledged that the new requirements could divert already scarce resources away from FDA’s primary task of evaluating drug safety. Representative Frank Pallone (D–NJ) wondered whether the bill’s call for FDA to prepare 15 new guidance documents might prevent the agency from “actually getting work done.” That concern was echoed by the two witnesses from FDA, Janet Woodcock and Jeffrey Shuren, directors of the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health, respectively. “We’re very stretched,” Woodcock told the panel, and FDA’s advisory meetings with drug developers might be one of the first functions to be cut if the agency continues to take on new congressionally mandated roles.

Today’s hearing was just another step in what is expected to be a long effort to transform the 21st Century Cures proposal into law. Both the House committee and the full body must ultimately approve any bill, which will then have to be reconciled with any legislation produced by the Senate, which has just begun to examine similar issues.

With reporting by Jocelyn Kaiser.