IB 

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 


pbinns on DSK79D2C42PROD with BILLS
2 

•HR 938 RH

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. 


pbinns on DSK79D2C42PROD with BILLS
3 

•HR 938 RH

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Bringing Low-cost Op5 tions and Competition while Keeping Incentives for New 

6 Generics Act of 2019’’ or the ‘‘BLOCKING Act of 2019’’. 

7 SEC. 2. CHANGE CONDITIONS OF FIRST GENERIC EXCLU8 SIVITY TO SPUR ACCESS AND COMPETITION. 

9 Section 505(j)(5)(B)(iv) of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amend11 ed— 

12 (1) in subclause (I), by striking ‘‘180 days 

13 after’’ and all that follows through the period at the 

14 end and inserting the following: ‘‘180 days after the 

15 earlier of— 

16 ‘‘(aa) the date of the first com17 mercial marketing of the drug (includ18 ing the commercial marketing of the 

19 listed drug) by any first applicant; or 

20 ‘‘(bb) the applicable date speci21 fied in subclause (III).’’; and 

22 (2) by adding at the end the following new sub23 clause: 

24 ‘‘(III) APPLICABLE DATE.—The appli25 cable date specified in this subclause, with 


pbinns on DSK79D2C42PROD with BILLS
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•HR 938 RH

1 respect to an application for a drug de2 scribed in subclause (I), is the date on 

3 which each of the following conditions is 

4 first met: 

5 ‘‘(aa) The approval of such an 

6 application could be made effective, 

7 but for the eligibility of a first appli8 cant for 180-day exclusivity under 

9 this clause. 

10 ‘‘(bb) At least 30 months have 

11 passed since the date of submission of 

12 an application for the drug by at least 

13 one first applicant. 

14 ‘‘(cc) Approval of an application 

15 for the drug submitted by at least one 

16 first applicant is not precluded under 

17 clause (iii). 

18 ‘‘(dd) No application for the drug 

19 submitted by any first applicant is ap20 proved at the time the conditions 

21 under items (aa), (bb), and (cc) are 

22 all met, regardless of whether such an 

23 application is subsequently ap24 proved.’’. 


pbinns on DSK79D2C42PROD with BILLS

pbinns on DSK79D2C42PROD with BILLS
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 

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

MAY 2, 2019 

Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 


pbinns on DSK79D2C42PROD with BILLS