U.S. Congress - H.R.3777 Drug Price Competition Act of 2009
H.R.3777 - Drug Price Competition Act of 2009
To amend the Federal Food, Drug, and Cosmetic Act to define the term "first applicant" for purposes of filing an abbreviated application for a new drug. view all titles (2)
All Bill Titles
- Short: Drug Price Competition Act of 2009 as introduced.
- Official: To amend the Federal Food, Drug, and Cosmetic Act to define the term "first applicant" for purposes of filing an abbreviated application for a new drug. as introduced.
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Official Summary
10/8/2009--Introduced.Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufaOfficial Summary
10/8/2009--Introduced.Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug....Read the Rest
Recent News Coverage
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Recent Blog Coverage
Antitrust Enforcement Agencies Face Unprecedented Challenges
Fortunately, Congressman Hastings has sponsored H.R. 3777, which would reform the exclusivity provision so that a later patent challenger that successfully challenges the patent could share the exclusivity period. ...
Senator Nelson Takes Another Crack at the Drug Price Competition Act
Alcee Hastings (D-FL) introduced a companion bill (HR 3777) in the House of Representatives. Rep. Hastings also initially proposed his bill as an amendment to the House Health Care Reform Bill last November, but then withdrew it from ...
FDA Law Blog: Senators Introduce Access to Affordable Medicines ...
Upon introducing H.R. 3777, Rep. Hastings commented that the bill would “help achieve some of the goals that are essential to health care reform: ensuring fair market competition and increasing access to affordable drugs. ...
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