Legislative and Regulatory Responses to the FTC Study on Barriers to Entry in the Pharmaceutical Marketplace: Hearing Before the Committee on the Judiciary, United States Senate, One Hundred Eighth Congress, First Session, June 17, 2003
U.S. Government Printing Office, 2003 - Competition - 116 pages
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180-day exclusivity 30-month stay abuse action additional Administration affordable agreements allow Amendments American ANDA applicant approval believe bill billion brand brand name brand-name company bring Chairman Hatch challenge changes claim Commission Committee competition concerns Congress constitutional consumers controversy costs court court decision Declaratory Judgment delay discuss district drug companies drug manufacturers drug product effective ensure enter entry expiration FDA approval FDA's Federal Federal Trade Commission filed FTC Study going Hatch-Waxman hearing holder improper incentive increase industry innovator invalid issue lawsuit legislation limit litigation medicines months Orange Book paragraph IV certification passed patent infringement patent listing percent period pharmaceutical potential prescription drugs prior proposed provision question recommendations reduce regulations rule savings Senate settlements submitted suit Thank trigger
Page 102 - Such notice shall include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed.
Page 84 - York to provide consumers with information, education and counsel about goods, services, health, and personal finance; and to initiate and cooperate with individual and group efforts to maintain and enhance the quality of life for consumers. Consumers Union's income is solely derived from the sale of Consumer Reports, its other publications and from noncommercial contributions, grants and fees.
Page 95 - Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the HatchWaxman Amendments and recent Congressional action on amendments to Hatch- Waxman.
Page 29 - Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed; Proposed Rule, 67 Fed.
Page 27 - My oral presentation and responses to questions are my own, and do not necessarily represent the views of the Commission or any other Commissioner.
Page 99 - Orange Book," an applicant seeking approval for an ANDA must submit a certification to the patent Even an applicant whose ANDA is pending when additional patents are submitted...
Page 102 - Under the current regulations, the ANDA applicant who files a paragraph IV certification to a listed patent must notify the patent owner and the NDA holder for the listed drug that it has filed an ANDA containing a patent challenge.
Page 105 - ... and administrative review in recent years, as the courts, industry, and FDA have sought to interpret it in a way that is consistent both with the statutory text and with the legislative goals underlying the Hatch-Waxman Amendments. A series of Federal court decisions beginning with the 1998 Mova...
Page 31 - Pursuant to the FDC Act, a brand-name drug manufacturer seeking to market a new drug product must first obtain FDA approval by filing a New Drug Application ("NDA"). At the time the NDA is filed, the NDA filer must also provide the FDA with certain categories of information regarding patents that cover the drug that is the subject of its NDA." Upon receipt of the patent information, the FDA is required to list it in an agency publication entitled "Approved Drug Products with Therapeutic Equivalence,"...
Page 104 - In that case, some, or all of the 1 80-day period, could expire without the ANDA applicant marketing its generic drug. Conversely, if there is no court decision and the first applicant does not begin commercial marketing of the generic drug, there may be prolonged or indefinite delays in the beginning of the first applicant's 180-day exclusivity period. Approval of an ANDA has no effect on exclusivity, except if the sponsor begins to market the approved generic drug.