FDA generics competition, LDT sharing reforms, graded facility inspections for shortages
Mandate pushes FDA/Congress to stop brand tactics delaying generics, ease interlab sharing of laboratory-developed/modified tests, clarify FDA–CMS CLIA overlap, and use graded inspections plus Medicaid rebate exemptions to fix shortages.
Mandate
Mandate Ch. 14 (HHS) — FDA: prohibit parking first-generic rights; create remedies for samples and curb meritless citizen petitions; mechanisms to share LDTs without new-test burdens; clarify overlapping FDA/CMS test authorities; graded facility inspections, packaging facility codes, searchable reliability database; exempt multi-source generics from Medicaid rebates that penalize capacity investment.
Undo plan
1) Advance pro-competition generic reforms without compromising safety.
2) Regulate LDTs with risk-based frameworks that preserve innovation and accuracy.
3) Use shortage tools (graded inspections, transparency) while keeping rebate program integrity for Medicaid.
4) Publish joint FDA–CMS jurisdiction map.
5) Verify: generic entry times; shortage-list duration; LDT error rates.