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HR 639 114th Congress House Crime and Law Enforcement Administrative law and regulatory procedures Administrative remedies Department of Justice Drug safety, medical device, and laboratory regulation Drug trafficking and controlled substances Licensing and registrations Medical research

Improving Regulatory Transparency for New Medical Therapies Act

Introduced: February 2, 2015 See on congress.gov
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 Everywhere this bill has been 27 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 25, 2015
Became Public Law No: 114-89.
Nov 25, 2015
Signed by President.
Nov 19, 2015
Presented to President.
Nov 16, 2015
Mr. Griffith asked unanimous consent that the House agree to the Senate amendment. (consideration: CR H8212-8213)
Nov 16, 2015
Motion to reconsider laid on the table Agreed to without objection.
Nov 16, 2015
On motion that the House agree to the Senate amendment Agreed to without objection. (text as House agreed to Senate amendment: CR H8212-8213)
Nov 16, 2015
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)
Oct 27, 2015
Message on Senate action sent to the House.
Oct 26, 2015
Passed Senate with an amendment by Unanimous Consent.
Oct 26, 2015
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Oct 26, 2015
Measure laid before Senate by unanimous consent. (consideration: CR S7495)
Oct 26, 2015
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S7495)
Oct 26, 2015
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S7495)
Mar 17, 2015
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 16, 2015
Motion to reconsider laid on the table Agreed to without objection.
Mar 16, 2015
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H1638-1639)
Mar 16, 2015
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)
Mar 16, 2015
DEBATE - The House proceeded with forty minutes of debate on H.R. 639.
Mar 16, 2015
Considered under suspension of the rules. (consideration: CR H1638-1641)
Mar 16, 2015
Mr. Pitts moved to suspend the rules and pass the bill, as amended.
Mar 16, 2015
Placed on the Union Calendar, Calendar No. 26.
Mar 16, 2015
Committee on the Judiciary discharged.
Mar 16, 2015
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-41, Part I.
Feb 6, 2015
Referred to the Subcommittee on Health.
Feb 3, 2015
Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
Feb 2, 2015
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.
Feb 2, 2015
Introduced in House
 Plain-English summary Congressional Research Service

(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.

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.

What's happening now November 25, 2015

Became Public Law No: 114-89.

 Committees of jurisdiction 5
 Cosponsors 1
All 1 Democratic 1