United States 116th Congress ✓ Enacted · P.L. 116-304 1 R cosponsors

HR 5663 — Safeguarding Therapeutics Act

Last action — Became Public Law No: 116-304.

  1. ✓
    Introduced
  2. ✓
    In Committee
  3. ✓
    Passed House
  4. ✓
    Passed Senate
  5. ✓
    To Executive
  6. 6
    Enacted

This bill has been enacted into law. Introduced January 21, 2020. Enacted.

Odds of enactment

High chance

Based on the sponsor, cosponsors, and committee posture, this bill has a high chance of becoming law.

Upgrade to see the exact probability and what's driving it.

A statistical estimate from our own model of past outcomes — an insight, not a guarantee. Policymaking is volatile.

Prognosis

Advancing 52% · moderate confidence

  • Enacted

    Current position in the legislative process.

  • 1 sponsor

    1 primary, 0 co-sponsors signed on.

  • Single-party support

    Sponsorship is currently within one party (1 R).

Based on stage, sponsorship breadth, committee status, recorded votes, and cross-state momentum — a description of the observable signals, not a prediction.

Summary

Safeguarding Therapeutics Act This bill authorizes the Food and Drug Administration to destroy imported counterfeit medical devices.

Bill Text

What changed in the latest version

60 added · 57 removed

Plain-language change summary

The amendment clarifies the authority of the Secretary of Health and Human Services to destroy drugs or devices that have been refused admission, without allowing for an opportunity to export them. Previously, the text included language about the Secretary of the Treasury overseeing the destruction of such articles, with stipulations for exporting them within a specific timeframe. This change simplifies the process by enabling the Secretary of Health and Human Services to act independently in destroying counterfeit devices promptly, which may enhance public safety regarding harmful products.

→
Previous
Latest
[Congressional Bills 116th Congress] [From the U.S.
[116th Congress Public Law 304] [From the U.S.
Government Publishing Office] [H.R.
Government Publishing Office] [[Page 134 STAT.
5663 Engrossed Amendment Senate (EAS)] <DOC> In the Senate of the United States, December 8, 2020.
4915]] Public Law 116-304 116th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices.
Resolved, That the bill from the House of Representatives (H.R.
<<NOTE:
5663) entitled ``An Act to amend the Federal Food, Drug, and Cosmetic Act to give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices.'', do pass with the following AMENDMENT:
Jan.
Strike all after the enacting clause and insert the following:
5, 2021 - [H.R.
SECTION 1.
5663]>> Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, <<NOTE:
SHORT TITLE.
Safeguarding Therapeutics Act.>> SECTION 1.
<<NOTE:
21 USC 301 note.>> SHORT TITLE.
and (2) by striking ``The Secretary of the Treasury shall cause the destruction of'' and all that follows through ``liable for costs pursuant to subsection (c).'' and inserting the following:
and (2) <<NOTE:
``The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C.
Notices.>> by striking ``The Secretary of the Treasury shall cause the destruction of'' and all that follows through ``liable for costs pursuant to subsection (c).'' and inserting the following:
``The <<NOTE:
Regulations.
Deadline.>> Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C.
The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection.
<<NOTE:
Regulations.>> The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection.
Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).''.
Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance [[Page 134 STAT.
4916]] of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).''.
Attest:
Approved January 5, 2021.
Secretary.
LEGISLATIVE HISTORY--H.R.
116th CONGRESS 2d Session H.R.
5663:
5663 _______________________________________________________________________ AMENDMENT
--------------------------------------------------------------------------- HOUSE REPORTS:
No.
116-512 (Comm.
on Energy and Commerce).
CONGRESSIONAL RECORD, Vol.
166 (2020):
Sept.
21, considered and passed House.
Dec.
8, considered and passed Senate, amended.
Dec.
10, House concurred in Senate amendment.
<all>
⬇ Download PDF
View plain text versions (7)

How this bill changes current law

3 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill grants the Secretary of Health and Human Services the authority to destroy counterfeit devices under the Federal Food, Drug, and Cosmetic Act.

  • 21 U.S.C. 381(a)

    The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug, device, or tobacco product refused admission under this section, if such drug, device, or tobacco product is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug, device, or tobacco product under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug, device, or tobacco product. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, device, or tobacco product, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug, device, or tobacco product after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). → The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1))) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).

    This change allows for the destruction of counterfeit devices and establishes a process for due process rights regarding such destruction.

  • 21 U.S.C. 321(h)

    (h) The term → (h)(1) The term

    This change reorganizes the definition section for clarity and consistency regarding terms related to counterfeit devices.

  • 21 U.S.C. 321(h)

    (2) The term `counterfeit device' means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.

    This provides a formal definition of 'counterfeit device' to aid in enforcement and regulatory actions.

Action History

  1. Introduced in House

  2. Introduced in House

  3. Referred to the House Committee on Energy and Commerce.

  4. Referred to the Subcommittee on Health.

  5. Ordered to be Reported by Voice Vote.

  6. Subcommittee Consideration and Mark-up Session Held.

  7. Committee Consideration and Mark-up Session Held.

  8. Ordered to be Reported (Amended) by Voice Vote.

  9. Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-512.

  10. Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-512.

  11. Placed on the Union Calendar, Calendar No. 412.

  12. Mrs. Dingell moved to suspend the rules and pass the bill, as amended.

  13. Considered under suspension of the rules. (consideration: CR H4635-4636)

  14. DEBATE - The House proceeded with forty minutes of debate on H.R. 5663.

  15. Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.

  16. On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4635)

  17. Motion to reconsider laid on the table Agreed to without objection.

  18. Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  19. Measure laid before Senate by unanimous consent. (consideration: CR S7286)

  20. Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

  21. Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

  22. Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.

  23. Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7286)

  24. Message on Senate action sent to the House.

  25. Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.

  26. Mrs. Dingell asked unanimous consent to take the bill, H.R. 5663 from the Speaker's Table and agree to the Senate amendment. (consideration: CR H7131)

  27. Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text: CR H7131)

  28. On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7131)

  29. Motion to reconsider laid on the table Agreed to without objection.

  30. Presented to President.

  31. Presented to President.

  32. Signed by President.

  33. Signed by President.

  34. Became Public Law No: 116-304.

  35. Became Public Law No: 116-304.

Sponsors

Sponsorship breakdown

Export CSV (upgrade) →

1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

Show all 546 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

healthcare health-insurance
Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

What does HR 5663 do?
Safeguarding Therapeutics Act This bill authorizes the Food and Drug Administration to destroy imported counterfeit medical devices.
Who sponsors HR 5663?
HR 5663 is sponsored by Guthrie, Brett (Republican).
What is the current status of HR 5663?
This bill has been enacted into law. Introduced January 21, 2020. Enacted.
Where can I track HR 5663?
Track HR 5663 free on One Click Politics — get push/email alerts when it moves.

Make your voice heard on HR 5663

Find the representatives who decide this bill and tell them where you stand — for yourself, or mobilize your whole list in one click with One Click Politics advocacy software.

Find my representatives → Run a campaign

Stay ahead of HR 5663

Last checked for changes 3 months ago · updated continuously

One Click Politics tracks every bill in Congress and all 50 states.

Track this bill →