Improving Regulatory Transparency for New Medical Therapies Act
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S 481 — Improving Regulatory Transparency for New Medical Therapies Act
Last action — Placed on Senate Legislative Calendar under General Orders. Calendar No. 245.
No card. One bill, free forever — alerts when it moves.
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✓Introduced
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Died in session
This bill died with 114th Congress. It reached “Introduced” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.
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 S 481 on the official United States source →Action History
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 245.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
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Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
- Orrin Hatch · Primary
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.
Subjects
Frequently asked questions
- What does S 481 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 S 481?
- S 481 is sponsored by Orrin Hatch (R).
- What is the current status of S 481?
- This bill died with 114th Congress. It reached “Introduced” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
- Where can I track S 481?
- Track S 481 free on One Click Politics — get push/email alerts when it moves.
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