Improving Regulatory Transparency for New Medical Therapies Act
Public Law 114-89 · H.R. 639 · 114th Congress · began in the House
Signed by Barack Obama (D) on Nov 25, 2015 · Crime and Law Enforcement
Sponsor: Rep. Joseph Pitts (R-PA-16)
Cosponsors (3): Rep. Frank Pallone, Rep. Gene Green,
Passage votes
- HouseUnanimous consent
- SenateUnanimous consent
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
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.
Committees
The committees the bill was sent to, and what each did with it.
- Judiciary Committee · House · discharged from, referred toSubcommittee: Crime and Federal Government Surveillance Subcommittee
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Related bills
1 bill the Library of Congress relates to this one.
S. 481Related bill
Improving Regulatory Transparency for New Medical Therapies Act
Data notes
Related bills are identified by the Congressional Research Service, the House and the Senate: companion and identical bills, bills with similar text, bills that were folded into this law, and rules that brought it to the floor. A bill that is itself a public law in this site’s data links here; the others link to Congress.gov.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 24 actions.
- Nov 25, 2015Became lawBecame law · Became Public Law No: 114-89.
- Became lawBecame law · Signed by President.
- Nov 19, 2015FloorFloor · Presented to President.
- Nov 16, 2015Resolving differencesResolving differences · Motion to reconsider laid on the table Agreed to without objection.
- Resolving differencesResolving differences · On motion that the House agree to the Senate amendment Agreed to without objection.
- Resolving differencesResolving differences · Mr. Griffith asked unanimous consent that the House agree to the Senate amendment.
- OtherOther · Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.
- Oct 27, 2015FloorFloor · Message on Senate action sent to the House.
- Oct 26, 2015FloorFloor · Passed Senate with an amendment by Unanimous Consent.
- FloorFloor · Measure laid before Senate by unanimous consent.
- CommitteeCommittee · Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
- Mar 17, 2015CommitteeCommittee · Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Mar 16, 2015FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
- FloorFloor · DEBATE - The House proceeded with forty minutes of debate on H.R. 639.
- FloorFloor · Considered under suspension of the rules.
- FloorFloor · Mr. Pitts moved to suspend the rules and pass the bill, as amended.
- CalendarCalendar · Placed on the Union Calendar, Calendar No. 26.
- CommitteeCommittee · Committee on the Judiciary discharged.
- CommitteeCommittee · Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-41, Part I.
- Feb 6, 2015CommitteeCommittee · Referred to the Subcommittee on Health.
- Feb 3, 2015CommitteeCommittee · Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
- Feb 2, 2015CommitteeCommittee · 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.
- IntroducedIntroduced · Introduced in House
Data notes
Every action the Library of Congress lists for the bill, from introduction to signing, plus the dated committee hearings. The source lists many steps twice (the chamber’s own entry and the Library of Congress copy, or a presidential and a became-law entry with the same words); those are shown once. Amendments are listed in their own section.
Amendments
1 amendment offered to the bill, with the last recorded step of each.
- Agreed to
S.Amdt. 2748SenateSen. Lamar AlexanderR-TN· offered Oct 26, 2015Agreed to
In the nature of a substitute.
Oct 26, 2015: Amendment SA 2748 agreed to in Senate by Unanimous Consent.
Data notes
Amendments offered to this bill in either chamber, as the Library of Congress records them: each with a status read from its last recorded step: agreed to, rejected, withdrawn, ruled out of order, fell with another amendment, or offered with no vote recorded (most Senate amendments are only ever offered). The wording of each amendment is the source’s. Amendments to amendments and amendments to other bills are not listed.
Official record
The bill’s full text is on Congress.gov. Data through Oct 7, 2026.