116 HR 4244 IH: Market Access for Generic Insulin Competition U.S. House of Representatives 2019-09-09 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.
I116th CONGRESS1st SessionH. R. 4244IN THE HOUSE OF REPRESENTATIVESSeptember 9, 2019Mr. Kelly of Pennsylvania introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo provide for a pathway for chemically synthesized insulin to be approved under an abbreviated new drug application submitted under the Federal Food, Drug, and Cosmetic Act, and for other purposes.
1.
Short title
This Act may be cited as the Market Access for Generic Insulin Competition or the MAGIC Act.
2.
Providing for a pathway for approval of chemically synthesized insulin under an abbreviated new drug application
(a)
In general
Section 7002(e)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 262 note) is amended— (1)in subparagraph (B), by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively, and moving the margins of such subclauses (as so redesignated) two ems to the right; (2)in subparagraph (A), by striking such biological product and inserting (i) such biological product; (3)by redesignating subparagraph (B) as clause (ii) and moving the margin of such clause (as so redesignated) two ems to the right; (4)in clause (ii) (as so redesignated), by striking the period at the end and inserting ; or; and (5)by adding at the end the following: (B)notwithstanding paragraphs (3) and (4), the application is submitted under subsection (j) of such section for chemically synthesized insulin or any analogue of chemically synthesized insulin for which the listed drug is a biological product that is, pursuant to paragraph (4), deemed to be licensed under section 351 of the Public Health Service Act.. (b)
Effective date
The amendments made by this section shall apply with respect to applications submitted on or after January 1, 2020.