HR 639 114th Congress

Improving Regulatory Transparency for New Medical Therapies Act

Latest Action

Became Public Law No: 114-89.

Congress.gov

Sponsors

Rep. Pitts, Joseph R. [R-PA-16]

Rep. Pitts, Joseph R. [R-PA-16]

R — PA

Summary

(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.
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 (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.
Improving Regulatory Transparency for New Medical Therapies Act Amends the Controlled Substances Act to require any proceedings for the issuance, amendment, or repeal of a rule of the Attorney General for the classification of a controlled substance that are initiated at the request of the Secretary of Health and Human Services to control a drug or other substance not previously scheduled, where the Secretary has recommended the drug or other substance be placed in schedule II, III, IV, or V, to be commenced not later than 120 days after receipt of written recommendations from the Secretary. Requires the final rule to be issued not later than 60 days after the date on which both the public comment period has closed and the new drug is the subject of an approved new drug application, unless a hearing on the proposed rule is granted by the Attorney General. Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule III, IV, or V for use only in a clinical trial, to register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, not later than 180 days after receiving an application and all information necessary to make a determination about whether the issuance of such registration is inconsistent with the public interest. Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule I or II for use only in a clinical trial, to: (1) issue a notice of application not later than 90 days after receipt of an application and all necessary information to issue such notice; and (2) register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, within 180 days following the close of the comment period and receipt of all information necessary to make a determination about whether the issuance of such registration is consistent with the public interest and with U.S. obligations under international treaties in effect on May 1, 1971, unless a hearing on the application has been granted pursuant to a provision of the Controlled Substances Import and Export Act regarding emergency situations.

Actions

2015-11-19T00:00:00

Presented to President.

2015-11-19T00:00:00

Presented to President.

2015-11-25T00:00:00

Became Public Law No: 114-89.

2015-11-25T00:00:00

Became Public Law No: 114-89.

2015-11-25T00:00:00

Signed by President.

2015-11-25T00:00:00

Signed by President.

2015-11-16T00:00:00

Motion to reconsider laid on the table Agreed to without objection.

2015-11-16T00:00:00

On motion that the House agree to the Senate amendment Agreed to without objection. (text as House agreed to Senate amendment: CR H8212-8213)

2015-11-16T00:00:00

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)

2015-11-16T00:00:00

Mr. Griffith asked unanimous consent that the House agree to the Senate amendment. (consideration: CR H8212-8213)

2015-10-27T00:00:00

Message on Senate action sent to the House.

2015-10-26T00:00:00

Passed Senate with an amendment by Unanimous Consent.

2015-10-26T00:00:00

Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.

2015-10-26T00:00:00

Measure laid before Senate by unanimous consent. (consideration: CR S7495)

2015-10-26T00:00:00

Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S7495)

2015-10-26T00:00:00

Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S7495)

2015-03-17T00:00:00

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

2015-03-16T00:00:00

Motion to reconsider laid on the table Agreed to without objection.

2015-03-16T00:00:00

On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H1638-1639)

2015-03-16T00:00:00

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)

2015-03-16T00:00:00

DEBATE - The House proceeded with forty minutes of debate on H.R. 639.

2015-03-16T00:00:00

Considered under suspension of the rules. (consideration: CR H1638-1641)

2015-03-16T00:00:00

Mr. Pitts moved to suspend the rules and pass the bill, as amended.

2015-03-16T00:00:00

Placed on the Union Calendar, Calendar No. 26.

2015-03-16T00:00:00

Committee on the Judiciary discharged.

2015-03-16T00:00:00

Committee on the Judiciary discharged.

2015-03-16T00:00:00

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-41, Part I.

2015-03-16T00:00:00

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-41, Part I.

2015-02-06T00:00:00

Referred to the Subcommittee on Health.

2015-02-03T00:00:00

Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.

2015-02-02T00:00:00

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.

2015-02-02T00:00:00

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.

2015-02-02T00:00:00

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.

2015-02-02T00:00:00

Introduced in House

2015-02-02T00:00:00

Introduced in House

Policy Areas

Crime and Law Enforcement

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