[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4244 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 4244

   To 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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 9, 2019

  Mr. Kelly of Pennsylvania introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Market Access for Generic Insulin 
Competition'' or the ``MAGIC Act''.

SEC. 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.
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