Monday, June 19, 2017

Senate panel to examine proposed FDA budget cuts

By Virgil Dickson  | June 17, 2017

The White House on Tuesday will defend proposed cuts to the Food and Drug Administration budget. Physicians fear that the cuts will mean lax oversight of drug approval, potentially putting patients at risk. A Senate Appropriations Committee subcommittee has scheduled a hearing on President Donald Trump's 2018 budget proposal for FDA, which calls for a $854 million cut, down 31% compared with 2017.

The proposal has sent a shudder through the provider community. "Financially starving the FDA severely hampers the agency's ability to protect (patients) from drugs that are ineffective at best and actively harmful at worst," Dr. John Meigs, president of the American Academy of Family Physicians, said in a statement released in response to Trump's budget.

To offset the loss, the budget proposes a $1.3 billion increase in user fees, paid by drug and device makers and used to support staff that assesses new products.

It's unclear if Republicans will seek the increase in user fees. Negotiations between congressional staffers, industry stakeholders and the FDA were already pretty far along in late May when Trump released his full budget proposal.

Earlier this year, Senate Republicans set an end of June deadline to conclude reauthorization of the drug and device user fees and warned that furlough notices could go out as soon as July if that deadline was missed.

Virgil Dickson reports from Washington on the federal regulatory agencies. His experience before joining Modern Healthcare in 2013 includes serving as the Washington-based correspondent for PRWeek and as an editor/reporter for FDA News. Dickson earned a bachelor's degree from DePaul University in 2007.

http://www.modernhealthcare.com/article/20170617/MAGAZINE/170619901?utm_source=modernhealthcare&utm_medium=email&utm_content=20170617-MAGAZINE-170619901&utm_campaign=hits

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