3.0.0 504 2022-11-15T16:34:52Z 2022-11-15T16:34:52Z Senate S S 2013-03-07 113 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2013-03-07T21:20:47Z 2013-03-07 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2013-03-07 Introduced in Senate IntroReferral 10000 9 Library of Congress F000457 Sen. Franken, Al [D-MN] Al Franken D MN N V000127 Sen. Vitter, David [R-LA] David Vitter R LA 2013-03-07 True D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2013-03-07 True S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH 2013-03-07 True S000033 Sen. Sanders, Bernard [I-VT] Bernard Sanders I VT 2013-03-07 True K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2013-03-11 False U000039 Sen. Udall, Tom [D-NM] TOM UDALL D NM 2013-03-20 False Health Drug safety, medical device, and laboratory regulation Government information and archives Intellectual property Marketing and advertising Prescription drugs Health 00 2013-03-07 Introduced in Senate 2013-03-19T20:22:43Z Fair And Immediate Release of Generic Drugs Act or FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patent holder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant).

Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing.

Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug.

Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement.

Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.

]]> FAIR Generics Act Display Title FAIR Generics Act Short Titles as Introduced FAIR Generics Act Short Titles as Introduced Fair And Immediate Release of Generic Drugs Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure that valid generic drugs may enter the market. Introduced in Senate 2013-03-07T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s504is/xml/BILLS-113s504is.xml 2013-03-07 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.