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Pharma industry shuns Trump push for radical shift at FDA

Source: Reuters

Wed Feb 15, 2017 | 1:26am EST

By Deena Beasley

U.S. President Donald Trump's vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines.

The prospect of big change at the regulatory agency comes as drugmakers are under fire for high prices, including Marathon Pharmaceuticals LLC, which said Monday it was "pausing" the launch of its Duchenne muscular dystrophy drug after U.S. lawmakers questioned its $89,000 a year price.

Industry trade group Biotechnology Innovation Organization told Reuters that during high-level discussions with Trump advisors, lobbyists urged the administration not to name a new commissioner of the Food and Drug Administration who would act rashly to speed up the agency’s approval of new medicines.

That sentiment was echoed by executives at more than a dozen pharmaceutical and biotechnology firms, who told Reuters that the FDA is already adopting new drug development models and warned that a looser review process would put patients at risk.

Read more: http://www.reuters.com/article/us-usa-trump-h...SKBN15U0GP

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