Title: Enhanced Access to Affordable Medicines Act of 2022
Policy area: Health

Summary:
Enhanced Access to Affordable Medicines Act of 2022
This bill specifies that the Food and Drug Administration may approve generic drugs with different labels than the brand-name versions if, among other requirements, the brand-name drug is subject to an active patent or exclusivity period and a revised label for the brand-name drug is approved within 90 days (rather than 60 days) of the expiration of the patent or exclusivity period.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6973 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 6973

   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 HOUSE OF REPRESENTATIVES

                             March 8, 2022

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

_______________________________________________________________________

                                 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. CLARIFYING THE CONDITIONS OF GENERIC DRUG APPLICATION APPROVAL 
              FOR LAST-MINUTE BRAND NAME DRUG LABELING CHANGES.

    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) the application is otherwise eligible for approval 
        under this subsection except that--
                    ``(I)(aa) the listed drug has an active patent, the 
                listed drug has an active exclusivity period, or there 
                is a delay in approval as described in paragraph 
                (5)(B)(iii); and
                    ``(bb) a revision to the labeling of the listed 
                drug has been approved by the Secretary within 90 days 
                of expiration of a patent, exclusivity period, or delay 
                in approval referenced in item (aa); or
                    ``(II) 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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