Project 2025 Tracker / What’s done, what’s next

14. Department of Health and Human Services · Minor · Needs Congress

Create legal remedies for generic makers to obtain brand-name samples

Not started

456 14. Department of Health and Human Services

“Additionally, Congress should create legal remedies for generic companies to obtain samples of brand-name products for their generic development efforts and should prohibit meritless “citizen petitions” submitted by manufacturers to delay approval of a generic competitor.”

What has happened

  1. Not started

    Already true before the evidence window: the CREATES Act of 2019 (Public Law 116-94, division N, title I, section 610, enacted 2019-12-20, codified at 21 U.S.C. 355-2) gives an eligible product developer a private right of action to obtain sufficient quantities of a covered brand-name product on commercially reasonable, market-based terms, with treble-damages exposure - exactly the legal remedy this ask asks Congress to create. The citizen-petition limb is answered by 21 U.S.C. 355(q), added by the FDA Amendments Act of 2007, which bars FDA from delaying a generic approval because of a petition unless delay is necessary to protect the public health and lets FDA deny petitions submitted primarily to delay. Nothing happened inside the window: no 119th-Congress bill revisits either provision.

    No action found yet. This entry is the starting point, not a finding.

Research log

What was searched, and what didn’t count as evidence

Research notes

  • 21 U.S.C. 355-2 read at https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapV-partA-sec355-2.htm; 21 U.S.C. 355(q) at https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapV-partA-sec355.htm. Both pre-date 2025-01-20 and so cannot be Evidence; they are why this ask is flagged Already true.
  • Boundary call: a reviewer who reads “prohibit meritless citizen petitions” as demanding an outright ban rather than the existing summary-denial authority would drop the flag and leave this a plain not started.
  • Confirmed 2026-09-01; the Already true flag is kept. The ask is to create something, not to preserve or continue it, so the flag is available. The boundary call above is the one live question, and it turns on whether anything the ask wants is still outstanding — not on whether anything happened inside the window, a test the rule no longer uses: the reading taken is that 21 U.S.C. 355(q) already does what the second limb asks — Congress legislated on meritless petitions and gave FDA the power to deny them and to refuse to delay an approval because of them — so both limbs were satisfied on 2025-01-20. The reading is left as recorded rather than reopened, because reopening it is a research question about what 355(q) does, not an application of the Already true rule.
  • Checked 2026-09-06: the flag stands. Both limbs rest on statute - 21 U.S.C. 355-2 (CREATES Act) and 21 U.S.C. 355(q) - so only Congress could undo the object, and none of the 104 public laws of the 119th Congress among the records we keep and search (searched again 2026-09-06) touches either provision. Nothing happened inside the window in either direction, so the rule as amended 2026-09-06 does not come into play. The live question on this item remains the one already recorded - whether 355(q) satisfies the citizen-petition limb at all - and that is a question about whether the flag was ever right, not about a reversal.
Action
create
Object
legal remedies for generic drug developers
ID
1225