[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4351 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4351

   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
 conditions under which the Secretary of Health and Human Services can 
 approve generic drug applications with labeling temporarily different 
           than the brand name drug, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 6, 2022

 Mr. Romney (for himself, Ms. Hassan, Ms. Rosen, and Mr. Hickenlooper) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
 conditions under which the Secretary of Health and Human Services can 
 approve generic drug applications with labeling temporarily different 
           than the brand name drug, 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 ``Enhanced Access to Affordable 
Medicines Act of 2022''.

SEC. 2. ENHANCING ACCESS TO AFFORDABLE MEDICINES.

    Section 505(j)(10)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)(10)(A)) is amended by striking clauses (i) through 
(iv) and inserting the following:
            ``(i) a revision to the labeling of the listed drug has 
        been approved by the Secretary within 90 days of when the 
        application is otherwise eligible for approval under this 
        subsection;
            ``(ii) the sponsor of the application agrees to submit 
        revised labeling for the drug that is the subject of the 
        application not later than 60 days after approval under this 
        subsection of the application; and
            ``(iii) the labeling revision described under clause (i) 
        does not include a change to the `Warnings' section of the 
        labeling.''.
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