Improving Regulatory Transparency for New Medical Therapies Act

Bill: 114-s-481
Sponsor: Sen. Hatch, Orrin G. [R-UT]
Introduced: 2015-02-12 in the Senate
Policy area: Health
Subjects: 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

Summary:
action_date: 2015-02-12
text: 

Improving Regulatory Transparency for New Medical Therapies Act

 
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.
 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.
action_date: 2015-10-01
text: 

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.


Legislative actions:
action_date: 2015-10-01
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 245.
action_date: 2015-10-01
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2015-10-01
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
action_date: 2015-09-30
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2015-02-12
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2015-02-12
text: Introduced in Senate