United States 114th Congress Status: Enacted 1 R cosponsors

HR 639 — Improving Regulatory Transparency for New Medical Therapies Act

Last action — Became Public Law No: 114-89. (TXT | PDF)

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  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 February 02, 2015. Enacted.

Summary

Improving Regulatory Transparency for New Medical Therapies Act (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs. This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately. For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later. (Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant. (Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.

Bill Text

We don't have the full text on file for this bill yet.

Read HR 639 on the official United States source →

Action History

  1. Became Public Law No: 114-89. (TXT | PDF)

  2. Signed by President.

  3. Presented to President.

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

  5. On motion that the House agree to the Senate amendment Agreed to without objection. (text as House agreed to Senate amendment: CR H8212-8213)

  6. Mr. Griffith asked unanimous consent that the House agree to the Senate amendment. (consideration: CR H8212-8213)

  7. Message on Senate action sent to the House.

  8. Passed Senate with an amendment by Unanimous Consent.

  9. S.Amdt.2748 Amendment SA 2748 agreed to in Senate by Unanimous Consent.

  10. S.Amdt.2748 Amendment SA 2748 proposed by Senator Portman for Senator Alexander. (consideration: CR S7495)

  11. Measure laid before Senate by unanimous consent. (consideration: CR S7495)

  12. Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S7495)

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

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

  15. On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H1638-1639)

  16. DEBATE - The House proceeded with forty minutes of debate on H.R. 639.

  17. Considered under suspension of the rules. (consideration: CR H1638-1641)

  18. Mr. Pitts moved to suspend the rules and pass the bill, as amended.

  19. Placed on the Union Calendar, Calendar No. 26.

  20. Committee on the Judiciary discharged.

  21. Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-41, Part I.

  22. Referred to the Subcommittee on Health.

  23. Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.

  24. Referred to House Judiciary

  25. Referred to House Energy and Commerce

  26. Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

  27. Introduced in House

Sponsors

Sponsorship breakdown

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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.

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"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 technology
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Frequently asked questions

What does HR 639 do?
Improving Regulatory Transparency for New Medical Therapies Act (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs. This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately. For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later. (Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant. (Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.
Who sponsors HR 639?
HR 639 is sponsored by Joseph Pitts (R).
What is the current status of HR 639?
This bill has been enacted into law. Introduced February 02, 2015. Enacted.
Where can I track HR 639?
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