PlainBillCongress, translated.Legislation. Context. Public interest.Became Public Law No: 114-89.
Congressional Research Service
Version 49 · Public Law · Nov 25, 2015
(This measure has not been amended since it was passed by the Senate on October 26, 2015. The summary of that version is repeated here.)
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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Rep. Pitts, Joseph R. [R-PA-16] · R–PA
Legislative record
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Became Public Law No: 114-89.
Became Public Law No: 114-89.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Motion to reconsider laid on the table Agreed to without objection.
On motion that the House agree to the Senate amendment Agreed to without objection. (text as House agreed to Senate amendment: CR H8212-8213)
Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text as House agreed to Senate amendment: CR H8212-8213)
Mr. Griffith asked unanimous consent that the House agree to the Senate amendment. (consideration: CR H8212-8213)
Message on Senate action sent to the House.
Passed Senate with an amendment by Unanimous Consent.
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Measure laid before Senate by unanimous consent. (consideration: CR S7495)
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S7495)
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S7495)
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H1638-1639)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H1638-1639)
DEBATE - The House proceeded with forty minutes of debate on H.R. 639.
Considered under suspension of the rules. (consideration: CR H1638-1641)
Mr. Pitts moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 26.
Committee on the Judiciary discharged.
Committee on the Judiciary discharged.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-41, Part I.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-41, Part I.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
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.
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.
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.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We currently store references to these documents.
Source last updated: Mar 4, 2026. Consult Congress.gov for the current record.
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