Title: BLOCKING Act of 2019
Policy area: Health

Summary:
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019
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 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 938 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 938

  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

                            January 31, 2019

  Mr. Schrader (for himself and 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, 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 2019'' or 
the ``BLOCKING Act of 2019''.

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

    Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended--
            (1) in subclause (I), by striking ``180 days after'' and 
        all that follows through the period at the end and inserting 
        the following: ``180 days after the earlier of--
                                    ``(aa) the date of the first 
                                commercial marketing of the drug 
                                (including the commercial marketing of 
                                the listed drug) by any first 
                                applicant; or
                                    ``(bb) the applicable date 
                                specified in subclause (III).''; and
            (2) by adding at the end the following new subclause:
                            ``(III) Applicable date.--The applicable 
                        date specified in this subclause, with respect 
                        to an application for a drug described in 
                        subclause (I), is the date on which each of the 
                        following conditions is first 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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