Should the Best Pharmaceuticals for Children Act be Amended to Accommodate 505(b)(2) NDA Labeling Carve-outs? “YES” . . . According to a New Bill in the U.S. Senate
Posted: 04 Jul 2017 08:14 PM PDT
By Kurt R. Karst –
We’re tickled pink here at the FDA Law Blog when we see an issue raised in one of our posts addressed in legislation. That happened last week when Senators Orrin Hatch (R-UT) and Robert Menendez (D-NJ) introduced the latest iteration of the Orphan Products Extension Now Accelerating Cures and Treatments Act (“OPEN Act”).
The OPEN Act, which draws inspiration from both the Best Pharmaceuticals for Children Act (“BPCA”) (FDC Act § 505A) and the Generating Antibiotic Incentives Now Act (“GAIN Act”) (FDC Act § 505E), would amend the FDC Act to add Section 505G, titled “Extension of Exclusivity Periods For A Drug Approved For A New Indication For A Rare Disease Or Condition,” to authorize FDA to designate a drug (including a biological product) “as a drug approved for a new indication to prevent, diagnose, or treat a rare disease or condition,” provided, among other things, that “prior to approval of an application or supplemental application for the new indication, the drug was approved or licensed for marketing under [FDC Act § 505(c)] or [PHS Act § 351(a)], but was not so approved or licensed for the new indication.” The designation of a drug approved for a new indication for a rare disease or condition would result in a 6-month extension of various exclusivities provided for under both the FDC Act and the PHS Act.
The OPEN Act of 2017 (S. 1509), is largely a rehash of previous versions of the bill . . . . except for Sections 3 and 4 of the bill. Of particular interest to this blogger is Section 4 of the OPEN Act of 2017. In March 2017, we put up a post, titled “Should the Best Pharmaceuticals for Children Act be Amended to Accommodate 505(b)(2) NDA Labeling Carve-outs?” We noted that the BPCA, and FDC Act § 505A(o) in particular, does not address 505(b)(2) NDAs. “The BPCA neither addresses the carve-out or retention of protected pediatric information from 505(b)(2) product labeling, nor does the BPCA address the use of disclaimers for protected pediatric use information that is carved-out of 505(b)(2) product labeling,” we stated. This leads to an inequity:
FDC Act § 505A(o) . . . allows an ANDA applicant to omit from its labeling certain patent- and/or exclusivity-protected information concerning the pediatric use of a drug, and to include a disclaimer with respect to the omitted information. . . .Section 4 of the OPEN Act of 2017 would remedy the inequity among ANDA and 505(b)(2) applicants that we pointed out by amending FDC Act § 505A(o) to include 505(b)(2) NDAs. Here’s how those proposed changes would appear in the statute if Section 4 of the OPEN Act of 2017 is enacted (deletions shown in strikethrough typeface and additions in bolded and italicized red typeface):
(o) PROMPT APPROVAL OF DRUGS UNDER SECTION 505(j) WHEN PEDIATRIC INFORMATION IS ADDED TO LABELING.—We’re honored that Senators Hatch and Menendez incorporated our suggestion into legislation, and we’ll be watching closely to see if Section 4 of the OPEN Act of 2017 makes it into FDARA and is enacted into law.
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