Improving Regulatory Transparency for New Medical Therapies Act
Latest action · Nov 25, 2015 Became Public Law No: 114-89.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedFeb 2, 2015
- Passed HouseMar 16, 2015
- Passed SenateOct 26, 2015
- To the PresidentNov 19, 2015
- Became lawNov 25, 2015
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.
Cosponsors 3
Members who signed on, in the order they did. Signatures ran from Feb 2, 2015 to Mar 16, 2015, with 2 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-NJ | Frank Pallone, Jr. | Original | Feb 2, 2015 |
| D-TX | Gene Green | Original | Feb 2, 2015 |
| R-WA | Cathy McMorris Rodgers | Mar 16, 2015 |
Actions 27
Everything that happened, newest first.
- Nov 25, 2015Became Public Law No: 114-89.
- Nov 25, 2015Signed by President.
- Nov 19, 2015Presented to President.
- Nov 16, 2015Motion to reconsider laid on the table Agreed to without objection.
- Nov 16, 2015Mr. Griffith asked unanimous consent that the House agree to the Senate amendment. (consideration: CR H8212-8213)
Amendments 1
Amendments offered to this bill.
| Amendment | Description | Offered by | Status |
|---|---|---|---|
| SA 2748 | In the nature of a substitute. | Lamar Alexander R-TN | Amendment SA 2748 agreed to in Senate by Unanimous Consent. |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 481 | Improving Regulatory Transparency for New Medical Therapies Act | Related bill | Oct 1, 2015 |
Subjects
Assigned by the Library of Congress. Policy area: Crime and Law Enforcement.
Text 6
Each version as it was printed, newest first.
- —Enrolled Bill
- Oct 26, 2015Engrossed Amendment Senate
- Mar 17, 2015Referred in Senate
- Mar 16, 2015Engrossed in House
- Mar 16, 2015Reported in House
- Feb 2, 2015Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.
