US lawmakers seek to revamp biomedical research

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 additional 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, the Michigan Republican who leads the Energy and Commerce Committee, and Diana DeGette, a Democrat from 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.

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, he and DeGette appear to have diverged in recent months; she 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 far-ranging. It would increase funding for the NIH’s National Center for Advancing Translational Sciences (NCATS), particularly 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.

The bill also includes a number of reforms to FDA programmes, such as making it easier for patients in dire need to obtain experimental therapies, and including 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 making treatments determined to be greatly needed.

The lawmakers also include provisions to combat antibiotic resistance, including new research and surveillance programmes and incentives for companies to develop new antibiotics.

But there are some notable omissions — including expected provisions on precision medicine and travel rules for NIH employees.

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: 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, associate vice-president for federal relations at the Association of American Universities in Washington DC, is also positive about the effort and 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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