Antibiotic Incentives, LDT Reform Left Out Of E&C’s Draft User Fee Bill

The House Energy & Commerce Committee on Wednesday (May 4) unveiled a draft user fee reauthorization package that addresses several hot-button issues, including FDA’s accelerated approval pathway and inspection authorities , but missing from the legislation are measures to incentivize antimicrobial drug development and give FDA authority over laboratory-developed tests. Key lawmakers have introduced antimicrobial drug and LDT legislation and have indicated they would like to get them passed with a larger legislative vehicle. Both issues have been a key...