US Spending Bill Rider Looks To Stop Already Halted FDA LDT Guidance
Executive Summary
A US FDA spending bill approved by the House Appropriations Committee July 12 would halt finalization of the agency's draft 2014 laboratory developed test guidance, recommending that FDA let Congress write its own bill directing any LDT regulation – but FDA already essentially handed the LDT reins to lawmakers last January.
You may also be interested in...
Lacking A New Budget Cap, Senate Panel Passes $2.8Bn Funding Bill For FDA
The Senate Appropriations Committee, forced to adhere to 2017 spending rules due to an impasse between the president and Congress, approved an Agriculture/FDA spending bill that would give FDA $2.8bn in discretionary dollars for 2018.
House Appropriators Will Tell US FDA 'Don't Finalize' LDT Guidance In 2018 Funding Bill
When the House Appropriations Committee takes up the US FDA funding bill for 2018, report language would "prevent the agency from finalizing a guidance on regulating laboratory developed tests," Rep. Rosa DeLauro said at a June 28 Ag/FDA subcommittee markup. The House bill, while maintaining FDA discretionary funding at its prior-year $2.8bn level, also fully appropriates user fee authorizations agreed to by Senate and House Committees in FDA Reauthorization bills in May and June, respectively.
US Congress 'May' Finish Diagnostic Regulatory Reforms By End Of 2017, Rep. Burgess Says
Congress may complete work they started in March on the 'Diagnostic Accuracy and Innovation Act' by the end of this legislative year, Rep. Michael Burgess, R-Texas, said. But if not, almost certainly it will be addressed by the end of 2018, before the 115th Congress adjourns.