Recent Developments which May Impact Consumer Access To, and Demand For, Pharmaceuticals: Hearing Before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventh Congress, First Session, June 13, 2001, Volume 4U.S. Government Printing Office, 2001 - 235 pages |
Other editions - View all
Common terms and phrases
180-day exclusivity agency ANDA Andrx's antihistamine antihistamine and antihistamine/decongestant approved drug approved drug product benefit BILIRAKIS billion bioequivalence Biovail brand name drug broadcast advertisements BURR cetirizine Chairman Citizen Petition Claritin Committee competition Congress cost court decision delay DELGADO Downey Drug Administration drug applications DTC advertising evaluated expired FDA's FDCA federal defendants filed Food and Drug GEISER Golenski Hatch-Waxman hearing Hispanic ibuprofen impact industry innovator drug issues KINGHAM labeling litigation loratadine medications medicines Michael Bilirakis neric Orange Book OTC status OTC switch over-the-counter status PALLONE patent challenge patent listing percent pharmaceutical Pharmacy PhRMA physician pioneer prescription drug public health questions regulations regulatory risk ROPES & GRAY RxHealthValue safe and effective safety side effects sponsors statement STUPAK Subcommittee submitted sumers testimony Thank therapeutically equivalent therapies Tiazac tion Waxman-Hatch Act WellPoint WOODCOCK Zyrtec
Popular passages
Page 76 - ... (B) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug...
Page 75 - Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users...
Page 82 - Except in cases of willfulness or those in which public health, interest, or safety requires otherwise, no withdrawal, suspension, revocation, or annulment of any license shall be lawful unless, prior to the institution of agency proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee by the agency in writing and the licensee shall...
Page 76 - ... if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the...
Page 76 - Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of...
Page 82 - ... includes the whole or part of an agency permit, certificate, approval, registration, charter, membership, statutory exemption or other form of permission; (9) "licensing" includes agency process respecting the grant, renewal, denial, revocation, suspension, annulment, withdrawal, limitation, amendment, modification, or conditioning of a license; (10) "sanction...
Page 19 - 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 - Certification The undersigned certifies, that to the best knowledge and belief of the undersigned, this petition includes all information and views on which...
Page 80 - Thus, as long as Monsanto is aware of the conditions under which the data are submitted, and the conditions are rationally related to a legitimate government interest, a voluntary submission of data by an applicant in exchange for the economic advantages of a registration can hardly be called a taking.
Page 78 - Any drug limited to prescription use under section 503(b)(l)(C) of the act shall be exempted from prescription-dispensing requirements when the Commissioner finds such requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed labeling.