Improving Regulatory Transparency for New Medical Therapies Act
Latest action · Oct 1, 2015 Placed on Senate Legislative Calendar under General Orders. Calendar No. 245.
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 12, 2015
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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 12, 2015 to Nov 3, 2015; 1 is an original cosponsor, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-RI | Sheldon Whitehouse | Original | Feb 12, 2015 |
| D-WA | Patty Murray | Sep 15, 2015 | |
| R-TN | Lamar Alexander | Nov 3, 2015 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| Senate | Health, Education, Labor, and Pensions Committee | Referred Feb 12, 2015Markup Sep 30, 2015Reported Oct 1, 2015 |
Actions 5
Everything that happened, newest first.
- Oct 1, 2015Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
- Oct 1, 2015Placed on Senate Legislative Calendar under General Orders. Calendar No. 245.
- Sep 30, 2015Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Feb 12, 2015Introduced in Senate
- Feb 12, 2015Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 639 | Improving Regulatory Transparency for New Medical Therapies Act | Related bill | Nov 25, 2015 |
Titles 3
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to amend the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufacturers and distributors seeking to conduct clinical testing, and for other purposes.
- Short Titles as Introduced
- Improving Regulatory Transparency for New Medical Therapies Act
- Short Titles as Reported to Senate
- Improving Regulatory Transparency for New Medical Therapies Act
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Drug therapy
- Drug trafficking and controlled substances
- Food and Drug Administration (FDA)
- Health
- Intellectual property
- Licensing and registrations
- Veterinary medicine and animal diseases
Text 2
Each version as it was printed, newest first.
- Oct 1, 2015Reported to Senate
- Feb 12, 2015Introduced in Senate
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; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
