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US lawmakers seek to revamp biomedical research

Plan would hasten development of new treatments with major changes to key government agencies.

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Days after the White House announced a new precision-medicine initiative, an influential group of US lawmakers has released its own wish list for biomedical research. On 27 January, several members of the House of Representatives released the first draft of their long-anticipated proposal to speed the translation of research into medicine.

The effort, known as 21st Century Cures, seeks to streamline research and development at the US National Institutes of Health (NIH) and US Food and Drug Administration (FDA). Biomedical-research advocates welcome the proposal. But they worry that winning the extra funding it would require will be difficult, given the tight US budget climate.

The 393-page document is the result of a rare bipartisan cooperation between a group of House members led by Fred Upton (Republican, Michigan), who chairs the Energy and Commerce Committee, and Diana DeGette (Democrat, Colorado). Over the past nine months, the lawmakers have met with officials from the NIH, the FDA, patient advocacy groups and pharmaceutical companies as they shaped their plan.

Up for discussion

The legislation has not been formally introduced, and further changes are likely. “Everything is on the table as we hope to trigger a thoughtful discussion toward a more polished product,” Upton said in a statement.

Notably, Upton and DeGette's opinions seem to have diverged in recent months — DeGette did not endorse the latest version of the bill. “We look forward to receiving feedback on the issues identified in [Upton’s] draft document and other suggestions,” DeGette said in a statement. “I know that with continued engagement, we can reach a bipartisan consensus to help advance biomedical research and cures.”

Like the committee’s discussions, the draft bill is wide-ranging. It would increase funding for the NIH’s National Center for Advancing Translational Sciences (NCATS), particularly for an initiative that repurposes old drugs for different diseases. The plan also seeks more cash for the NIH’s Common Fund, which supports initiatives that do not fit into any one NIH institute. The House proposal would also expand the NIH’s authority to fund 'high-risk high-reward' research, create new programmes to support young scientists, and reduce the amount of paperwork in the NIH’s grant process.

Patient consideration

The draft bill includes a number of reforms to FDA programmes, such as making it easier for patientsto obtain experimental therapies if standard treatments have failed, and incorporating patient feedback in the agency’s regulatory approval process. In a move that seems likely to stir controversy, the House proposal would grant longer market-exclusivity periods to pharmaceutical and device companies that make much-needed product, such as therapies for rare diseases.

The lawmakers also include provisions to combat antibiotic resistance, such as new research and surveillance programmes and incentives for companies to develop new antibiotics. But there are some notable omissions — expected provisions on precision medicine, for example, and travel rules for NIH employees attending scientific conferences.

Early reactions from research-advocacy organizations are largely positive. Margaret Anderson, executive director of FasterCures in Washington DC, is particularly interested in the committee’s proposal to create public–private consortia to coordinate and fund biomedical research. Such cooperation is key, she says, because the most meaningful reforms would address “how you get the NIH and FDA to link arms. We want to see as much of that as possible.”

Carrie Wolinetz, deputy vice-president for federal relations at the Association of American Universities in Washington DC, is also positive about the effort. She says that Congress was clearly responsive to the concerns raised at hearings. “But the devil is all in the details in these initiatives,” she says. “We’ll have to wait and see if there is any funding.”

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