Industry Execs Lobby US Secretaries Ross, Price On Medtech Issues
A group of top medical device executives led by AdvaMed CEO Scott Whitaker met the US commerce and health secretaries to discuss key industry issues, including device tax repeal, FDA user-fee reauthorization, trade policies and reimbursement.
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The Trump White House is not backing down in its push to renegotiate the US FDA user-fee reauthorization deals that were inked during the Obama administration. The FY 2018 budget request would ask for more than a $200m increase in fees from device companies in the coming fiscal year to counterbalance major cuts in appropriations from Congress. That would make the agency's device program dependent on user fees for about 71% of its budget, versus about 27% currently. But Congress has already said it opposes the plan.
AdvaMed CEO Scott Whitaker says he is as confident as ever that permanent device tax repeal will happen this year. The only question is, he suggests, what legislative vehicle will bring it over the finish line. User-fee and children's health-insurance reauthorizations are options, along with tax reform, he says.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.