BLOCKING Act of 2021

Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the BLOCKING Act of 2021

This bill modifies provisions related to market exclusivity for a generic drug.

Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.

The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2853 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 2853

  To amend the Federal Food, Drug, and Cosmetic Act, with respect to 
 eligibility for approval of a subsequent generic drug, to remove the 
   barrier to that approval posed by the 180-day exclusivity period 
 afforded to a first generic applicant that has not yet received final 
                   approval, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 26, 2021

 Mr. Schrader 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, with respect to 
 eligibility for approval of a subsequent generic drug, to remove the 
   barrier to that approval posed by the 180-day exclusivity period 
 afforded to a first generic applicant that has not yet received final 
                   approval, 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 ``Bringing Low-cost Options and 
Competition while Keeping Incentives for New Generics Act of 2021'' or 
the ``BLOCKING Act of 2021''.

SEC. 2. CHANGE CONDITIONS OF FIRST GENERIC EXCLUSIVITY TO SPUR ACCESS 
              AND COMPETITION.

    Clause (iv) of section 505(j)(5)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)(B)) is amended--
            (1) in subclause (I), after ``180 days after the date of 
        the first commercial marketing of the drug (including the 
        commercial marketing of the listed drug) by any first 
        applicant'' by inserting ``or by an applicant whose application 
        is approved pursuant to subclause (III)''; and
            (2) by adding at the end the following new subclause:
                    ``(III) Applicant approval.--An application 
                containing a certification described in paragraph 
                (2)(A)(vii)(IV) that is for a drug for which a first 
                applicant has submitted an application containing such 
                a certification can be approved notwithstanding the 
                eligibility of a first applicant for the 180-day 
                exclusivity period described in subclause (II)(aa) if 
                each of the following conditions is met:
                            ``(aa) The approval of such an application 
                        could be made effective, but for the 
                        eligibility of a first applicant for 180-day 
                        exclusivity under this clause.
                            ``(bb) At least 30 months have passed since 
                        the date of submission of an application for 
                        the drug by at least one first applicant.
                            ``(cc) Approval of an application for the 
                        drug submitted by at least one first applicant 
                        is not precluded under clause (iii).
                            ``(dd) No application for the drug 
                        submitted by any first applicant is approved at 
                        the time the conditions under items (aa), (bb), 
                        and (cc) are all met, regardless of whether 
                        such an application is subsequently 
                        approved.''.
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