Text: H.R.938 — 116th Congress (2019-2020)All Information (Except Text)

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Reported in House (05/02/2019)

Union Calendar No. 24

116th CONGRESS
1st Session
H. R. 938

[Report No. 116–46]


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

May 2, 2019

Additional sponsors: Mrs. Craig, Mrs. Dingell, Mr. Ruiz, Mr. Pallone, Ms. Eshoo, Mr. Kennedy, Ms. Matsui, Mr. Rush, Mr. Van Drew, Ms. Clarke of New York, Mr. Walden, Ms. Schakowsky, Mr. McAdams, Ms. Mucarsel-Powell, and Mr. Meadows

May 2, 2019

Committed to the Committee of the Whole House on the State of the Union and ordered to be printed


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.”.


Union Calendar No. 24

116th CONGRESS
     1st Session
H. R. 938
[Report No. 116–46]

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.

May 2, 2019
Committed to the Committee of the Whole House on the State of the Union and ordered to be printed