BLOCKING Act of 2019

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 eligi- bility 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 VerDate Sep 11 2014 20:31 May 02, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H938.RH H938 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. VerDate Sep 11 2014 20:31 May 02, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6652 E:\BILLS\H938.RH H938 pbinns on DSK79D2C42PROD with BILLS 3 •HR 938 RH Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Bringing Low-cost Op- 4 tions and Competition while Keeping Incentives for New 5 Generics Act of 2019’’ or the ‘‘BLOCKING Act of 2019’’. 6 SEC. 2. CHANGE CONDITIONS OF FIRST GENERIC EXCLU- 7 SIVITY TO SPUR ACCESS AND COMPETITION. 8 Section 505(j)(5)(B)(iv) of the Federal Food, Drug, 9 and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amend- 10 ed— 11 (1) in subclause (I), by striking ‘‘180 days 12 after’’ and all that follows through the period at the 13 end and inserting the following: ‘‘180 days after the 14 earlier of— 15 ‘‘(aa) the date of the first com- 16 mercial marketing of the drug (includ- 17 ing the commercial marketing of the 18 listed drug) by any first applicant; or 19 ‘‘(bb) the applicable date speci- 20 fied in subclause (III).’’; and 21 (2) by adding at the end the following new sub- 22 clause: 23 ‘‘(III) APPLICABLE DATE.—The appli- 24 cable date specified in this subclause, with 25 VerDate Sep 11 2014 20:31 May 02, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H938.RH H938 pbinns on DSK79D2C42PROD with BILLS 4 •HR 938 RH respect to an application for a drug de- 1 scribed in subclause (I), is the date on 2 which each of the following conditions is 3 first met: 4 ‘‘(aa) The approval of such an 5 application could be made effective, 6 but for the eligibility of a first appli- 7 cant for 180-day exclusivity under 8 this clause. 9 ‘‘(bb) At least 30 months have 10 passed since the date of submission of 11 an application for the drug by at least 12 one first applicant. 13 ‘‘(cc) Approval of an application 14 for the drug submitted by at least one 15 first applicant is not precluded under 16 clause (iii). 17 ‘‘(dd) No application for the drug 18 submitted by any first applicant is ap- 19 proved at the time the conditions 20 under items (aa), (bb), and (cc) are 21 all met, regardless of whether such an 22 application is subsequently ap- 23 proved.’’. 24 VerDate Sep 11 2014 20:31 May 02, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H938.RH H938 pbinns on DSK79D2C42PROD with BILLS VerDate Sep 11 2014 20:31 May 02, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H938.RH H938 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 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 VerDate Sep 11 2014 20:31 May 02, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6651 Sfmt 6651 E:\BILLS\H938.RH H938 pbinns on DSK79D2C42PROD with BILLS