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The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

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STAT: Could the FDA Be Dismantled Under President Trump?

STATWashington, DC, November 29, 2016 — Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration?

Sheila Kaplan reports on STAT that it’s been less than a year since Dr. Robert Califf was sworn in as the FDA’s chief, but already the agency is facing post-election upheaval.

Public health advocates are bracing for a seismic shift: a surrender of the agency’s rules for off-label promotion of drugs; the importation of more drugs from other countries; and fewer requirements for clinical trials — long the gold standard for determining whether medicines are safe and effective.

“Between a Trump presidency and a radically pro-business Congress, the next few years may see a removal of numerous consumer protections,” said Michael Jacobson, cofounder and president of the Center for Science in the Public Interest.

For Trump and his advisers, including Newt Gingrich, the agency has for too long acted as a barrier to medical innovation.

Gingrich, the former speaker of the House, has previously described the FDA as the nation’s leading “job-killer” and called for its abolishment.  “The FDA is a major prison guard stopping the breakout in health,” he wrote in the National Review in 2013.

The FDA’s balancing act between patient protection and the drug and device industry’s push for a quicker path to market has never been easy.

But Califf, who had close ties to the pharmaceutical industry before his career at the FDA, has said there’s good reason.

For Kaplan’s full STAT story, click here.

Follow Kaplan on Twitter @BySheilaKaplan.

Follow STAT — which reports from the frontiers of health and medicine — on Twitter @statnews.