BLOCKING Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 2853 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 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 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 2021’’ or the ‘‘BLOCKING Act of 2021’’. 6 VerDate Sep 11 2014 02:46 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2853.IH H2853 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 2853 IH SEC. 2. CHANGE CONDITIONS OF FIRST GENERIC EXCLU- 1 SIVITY TO SPUR ACCESS AND COMPETITION. 2 Clause (iv) of section 505(j)(5)(B) of the Federal 3 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) 4 is amended— 5 (1) in subclause (I), after ‘‘180 days after the 6 date of the first commercial marketing of the drug 7 (including the commercial marketing of the listed 8 drug) by any first applicant’’ by inserting ‘‘or by an 9 applicant whose application is approved pursuant to 10 subclause (III)’’; and 11 (2) by adding at the end the following new sub- 12 clause: 13 ‘‘(III) APPLICANT APPROVAL.—An applica- 14 tion containing a certification described in para- 15 graph (2)(A)(vii)(IV) that is for a drug for 16 which a first applicant has submitted an appli- 17 cation containing such a certification can be ap- 18 proved notwithstanding the eligibility of a first 19 applicant for the 180-day exclusivity period de- 20 scribed in subclause (II)(aa) if each of the fol- 21 lowing conditions is met: 22 ‘‘(aa) The approval of such an appli- 23 cation could be made effective, but for the 24 eligibility of a first applicant for 180-day 25 exclusivity under this clause. 26 VerDate Sep 11 2014 02:46 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2853.IH H2853 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 2853 IH ‘‘(bb) At least 30 months have passed 1 since the date of submission of an applica- 2 tion for the drug by at least one first ap- 3 plicant. 4 ‘‘(cc) Approval of an application for 5 the drug submitted by at least one first ap- 6 plicant is not precluded under clause (iii). 7 ‘‘(dd) No application for the drug 8 submitted by any first applicant is ap- 9 proved at the time the conditions under 10 items (aa), (bb), and (cc) are all met, re- 11 gardless of whether such an application is 12 subsequently approved.’’. 13 Æ VerDate Sep 11 2014 02:46 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H2853.IH H2853 kjohnson on DSK79L0C42PROD with BILLS