Sec. 3. Definitions
387 words·~2 min read·
/bill/116/s/2387/is/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
For purposes of this Act: The term applicable drug means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )) that— is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ); is subject to section 503(b)(1) of such Act ( 21 U.S.C. 353(b)(1) ); and is covered by a qualifying patent on the drug, on a method of using such drug, or on a method or machine used to manufacture or administer such drug with respect to which the drug sponsor retained the title to any subject invention under section 202 of title 35, United States Code, or entered into a licensing agreement after the date of enactment of this Act.
The term conflict of interest means an association, including a financial or personal association, or past employment, that has the potential to bias or have the appearance of biasing an individual’s decisions in matters related to the Drug Affordability and Access Committee or the conduct of other activities under this Act. The term manufacturer list price means the national price for a prescription drug established by the manufacturer or licensee found in a catalogue or other public source that is the price from which market discounts and price concessions are calculated.
The term period of market exclusivity means any period of market exclusivity granted with respect to a prescription drug under clause (ii), (iii), or
(iv)of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) ), clause (ii), (iii), or
(iv)of section 505(j)(5)(F) of such Act, section 527 of such Act ( 21 U.S.C. 360cc ), or section 351(k)(7) of the Public Health Service Act ( 42 U.S.C. 262(k)(7) ), and any extension of such period granted under section 505A or 505E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a , 355f). The term qualifying patent means any patent— held by the Federal Government; or which the applicant with respect to the patent was required to disclose under section 202(c)(6) of title 35, United States Code, in the application for the patent. The term Secretary means the Secretary of Health and Human Services.
Connectionstraces to 6
Citation graph
cites case law
Cites 6Cited by 0 across 0 sources