Short-Term US Funding Bill Passes With $1.1bn In Emergency Zika Funds
Congress managed to settle its disputes over funding riders Sept. 28 and passed a relatively clean bill that contains $1.1bn in emergency Zika virus response funding, and will keep government agencies – including US FDA – running at current spending levels until Dec. 9.
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No significant trends emerged in diagnostics M&A or financing this past year, which did see the introduction of several government-funded initiatives, elements of which will bolster diagnostics innovation. As in other sectors of health care, the biggest question is how the incoming Trump administration could change US regulatory and funding policies.
With an all-Republican House, Senate and administration lined up to lead the government following the 2016 elections, the path is clear for passage of a set of FDA reforms to ease device approvals embedded in a combined House 'Cures' and Senate medical innovation package. It could even happen over the upcoming lame-duck session, before the new administration and Congress take over. But controversy around price-gouging by drug firms still could stymie quick Cures bill passage, an industry attorney predicts. Meanwhile, medtech industry groups plan to seize on the Trump victory as a means to achieve permanent device tax repeal.
As Congress squabbles over a federal funding bill to fight the virus, FDA reviewers are taking on extra duties and working overtime to approve Zika diagnostics quickly, device chief Jeff Shuren says. The most recent emergency-use authorization targeting Zika extended the usability of a Hologic assay to more patients.