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S 481 114th Congress Senate 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) Intellectual property Licensing and registrations Veterinary medicine and animal diseases

Improving Regulatory Transparency for New Medical Therapies Act

Introduced: February 12, 2015 See on congress.gov
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 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 1, 2015
Placed on Senate Legislative Calendar under General Orders. Calendar No. 245.
Oct 1, 2015
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Sep 30, 2015
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Feb 12, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Feb 12, 2015
Introduced in Senate
 Plain-English summary Congressional Research Service

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 October 1, 2015

Placed on Senate Legislative Calendar under General Orders. Calendar No. 245.

 Committees of jurisdiction 1
 Cosponsors 2
All 2 Democratic 2