US Congress House Bill 639 (Prior Session Legislation)

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Completed Legislative Action
Spectrum: Bipartisan Bill
Status: Passed on November 25 2015 - 100% progression
Action: 2015-11-25 - Became Public Law No: 114-89. (TXT | PDF)
Text: Latest bill text (Enrolled) [PDF]

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.

Improving Regulatory Transparency for New Medical Therapies Act

Rep. Joseph Pitts [R-PA]

Rep. Frank Pallone [D-NJ]

Rep. Gene Green [D-TX]

Rep. Cathy McMorris Rodgers [R-WA]

Date	Chamber	Action
2015-11-25	Senate	Became Public Law No: 114-89. (TXT | PDF)
2015-11-25	Senate	Signed by President.
2015-11-19	Senate	Presented to President.
2015-11-16	Senate	Motion to reconsider laid on the table Agreed to without objection.
2015-11-16	Senate	On motion that the House agree to the Senate amendment Agreed to without objection. (text as House agreed to Senate amendment: CR H8212-8213)
2015-11-16	Senate	Mr. Griffith asked unanimous consent that the House agree to the Senate amendment. (consideration: CR H8212-8213)
2015-10-27	Senate	Message on Senate action sent to the House.
2015-10-26	Senate	Passed Senate with an amendment by Unanimous Consent.
2015-10-26	Senate	S.Amdt.2748 Amendment SA 2748 agreed to in Senate by Unanimous Consent.
2015-10-26	Senate	S.Amdt.2748 Amendment SA 2748 proposed by Senator Portman for Senator Alexander. (consideration: CR S7495)
2015-10-26	Senate	Measure laid before Senate by unanimous consent. (consideration: CR S7495)
2015-10-26	Senate	Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S7495)
2015-03-17	Senate	Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
2015-03-16	House	Motion to reconsider laid on the table Agreed to without objection.
2015-03-16	House	On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H1638-1639)
2015-03-16	House	DEBATE - The House proceeded with forty minutes of debate on H.R. 639.
2015-03-16	House	Considered under suspension of the rules. (consideration: CR H1638-1641)
2015-03-16	House	Mr. Pitts moved to suspend the rules and pass the bill, as amended.
2015-03-16	House	Placed on the Union Calendar, Calendar No. 26.
2015-03-16	House	Committee on the Judiciary discharged.
2015-03-16	House	Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-41, Part I.
2015-02-06	House	Referred to the Subcommittee on Health.
2015-02-03	House	Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
2015-02-02	House	Referred to House Judiciary
2015-02-02	House	Referred to House Energy and Commerce
2015-02-02	House	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.
2015-02-02	House	Introduced in House

SB481 (Related) 2015-10-01 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 245.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/639/all-info
Text	https://www.congress.gov/114/bills/hr639/BILLS-114hr639ih.pdf
Text	https://www.congress.gov/114/bills/hr639/BILLS-114hr639rh.pdf
Text	https://www.congress.gov/114/bills/hr639/BILLS-114hr639eh.pdf
Text	https://www.congress.gov/114/bills/hr639/BILLS-114hr639eas.pdf
Text	https://www.congress.gov/114/bills/hr639/BILLS-114hr639enr.pdf