Griffith Bill Proposes Legislative Fix to “Route-of-Abuse” Exclusivity Block

April 9, 2017By Kurt R. Karst

In the rhythm of life, timing is everything! It was just last week when we posted on an interesting issue arising as a result of the intersection of exclusivity and off-label promotion.  We suggested that some controversy might arise as a result of some decisions (or indecision) from FDA.  Now Congress – and Rep. Morgan Griffith (R-VA) in particular – in legislation that was introduced on April 6, 2017, has proposed a way that would appear to avoid controversy.  But first, a little background . . . .

At the heart of the debate is FDA’s interpretation of the scope of 3-year new clinical investigation exclusivity under FDC Act § 505(c)(3)(E)(iii) and (iv) as it applies to subsequent 505(b)(2) NDA applicants in the context of abuse-deterrence drug products. FDA interprets the exclusivity to apply to a particular route of abuse instead of to a particular abuse-deterrent formulation.  As we mentioned last week (and discussed in prior postings – here and here), FDA’s “route-of-abuse” exclusivity approach prevented the Agency from approving  Egalet US, Inc.’s (“Egalet’s”) ARYMO ER (morphine sulfate) Extended-release Tablets (NDA 208603) with labeling that includes information from clinical studies Egalet conducted discussing ARYMO ER abuse-deterrence via the intranasal route of abuse.  Why?  Because another company – Inspirion Delivery Technologies, LLC (“Inspirion”) – had previously been granted a period of 3-year exclusivity for it’s MORPHABOND (morphine sulfate) Extended-release Tablets drug product (approved under NDA 206544).  Inspirion’s exclusivity is coded in the Orange Book as “M-189” (defined as “LABELING DESCRIBING THE EXPECTED REDUCTION OF ABUSE OF SINGLE-ENTITY EXTENDED-RELEASE MORPHINE BY THE INTRANASAL ROUTE OF ADMINISTRATION DUE TO PHYSICOCHEMICAL PROPERTIES”).

Enter Rep. Griffith with H.R. 2025, the “Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017.” The bill also has a long title: “To amend section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act to prevent certain applications from being considered ineligible for approval under section 505(c) of such Act on the basis that the proposed labeling includes information describing abuse-deterrent properties that otherwise would be blocked by exclusivity under clause (iii) or (iv) of section 503(c)(3)(E) of such Act, and for other purposes.” And the long title is nearly as long as the text needed to address the exclusivity-blocking issue.

H.R. 2025 would amend FDC Act § 505(c)(3)(E) to add new subparagraph (vi) as follows:

(vi) A drug for which an application (or a supplement to an application) described in subsection (b)(2) is submitted shall not be considered ineligible for approval under this subsection on the basis that its labeling includes information describing the abuse-deterrent properties of the drug (including abuse-deterrent claims) that otherwise would be blocked by exclusivity under clause (iii) or (iv) of this subparagraph if—

(I) the investigation or investigations relied upon by the applicant for approval of the labeling information were conducted by or for the applicant or the applicant has obtained a right of reference or use from the person by or for whom the investigation or investigations were conducted; and

(II) the drug has meaningful technological differences compared to the drug otherwise protected by exclusivity under clause (iii) or (iv) of this subparagraph.

Short and elegant! The change would apply with respect to NDAs (including supplements) submitted or pending on or after January 1, 2017.  And it just so happens that Egalet’s NDA 208603 for ARYMO ER was pending on that date. (NDA 208603 was not approved until January 9, 2017.)

H.R. 2025 would also require FDA to issue draft (and then final) guidance on the award and scope of 3-year exclusivity for abuse-deterrent drug product formulations.