US FDA's Gottlieb Wants Safety Built Into New Medtech Products, But Budget Will Be Cut To Surveil Older Ones
Executive Summary
President Trump's proposed budget cuts to the agency's post-market surveillance programs means that more "faulty" devices, such as St. Jude defibrillators and Bayer HealthCare's Essure birth control coils, will cause harm rather than be recalled, Rep. Rosa DeLauro said at a May 25 House Ag/FDA subpanel hearing. FDA Commissioner Scott Gottlieb told DeLauro the agency needs to supply "the right tools" to firms during device development so similarly flawed devices aren't put on the market, and he noted that the lifting of a hiring freeze at the agency earlier in the day would free the agency to work harder on such issues.
You may also be interested in...
US FDA User-fee Bill Will Pressure Budget In 2023
A provision in the FDARA user-fee bill prevents FDA from spending user-fee revenue on building maintenance costs beginning in FY 2023, which could deter future recruitment and retention of the "world's best and brightest" scientists at FDA, House Energy and Commerce ranking member Frank Pallone says.
Trump Budget: 71% Of US FDA Device Funding Would Come From User Fees
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.
A Burning FDA Hiring Freeze Question: What About User-Fee-Supported Staff?
Industry worries about user fee programs as US FDA could wait weeks before finding out how President Trump's hiring freeze affects it.