„SPA, a written commercial agreement representing an investment of capital”
Investment was not based on SPA, SPA was based on proposed investment and no policy or law exists regarding the "substantial scientific issue".
Amarin could sue FDA based on two reason: a.) the rescission itself (reason behind it) b.) the timing
a.) With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes, however it is not required by any law or regulation. It was the FDA’s practice. Furthermore, as lipids (except LDL-C) never was a validated surrogate-endpoint, the past practice does not obligate FDA to approve evry lipid-altering drug based on surrogate endpoint(s). It’s at least not a slam dunk.
b.) It could be ruled in favor of Amarin, since two of the referred studies was known more or less 2 years (the 3rd app. 10 months) before the rescission, so it was not within the reasonable period of time.
However if Amarin win the case – based on both reason or on b.) - it could be around mid-2017 only.
“Section 119(a) of the Modernization Act amends section 505(b) of the Act (21 U.S.C. 355(b)). New section 505(b)(4)(B) of the Act directs FDA to meet with sponsors, provided certain conditions are met, for the purpose of reaching agreement on the design and size of clinical trials intended to form the primary basis of an efficacy claim in a marketing application.”
“Upon specific request by a sponsor (including specific questions that the sponsor desires to be answered), the agency will evaluate certain protocols and issues to assess whether the design is adequate to meet scientific and regulatory requirements identified by the sponsor” at the time of the assessment.
“If an agreement is reached, the Agency will reduce the agreement to writing and make it part of the administrative record. An agreement may not be changed by the sponsor or FDA after the trial begins, except (1) with the written agreement of the sponsor and FDA, or (2) if the director of the FDA reviewing division determines that "a substantial scientific issue essential to determining the safety or effectiveness of the drug" was identified after the testing began (section 505(b)(4)(C) of the Act).”
“The Committee is aware of FDA’s ability to rescind a SPA agreement reached under section 505(b)(5)(C)(ii) of the Food, Drug, and Cosmetic Act only if it demonstrates that ‘‘a substantial scientific issue essential to determining the safety or efficacy of the product has been identified after the testing has begun.”
„The Committee also expects that, as a matter of public policy and fundamental fairness to the sponsor, FDA should be accountable for continued diligence in identifying issues that bear on the continued enforceability of a SPA agreement and in notifying the sponsor of such issues within a reasonable period of time after FDA becomes aware.”
„To ensure agreement over the standard to rescind a SPA, the Committee directs FDA to report to the Committees on Appropriations of the House and Senate within 60 days of enactment of this Act regarding the standard by which FDA would rescind a SPA. Lastly, to ensure agreement over the standard to rescind a SPA, the Committee directs FDA to revise and re-issue, after public comment, its existing guidance regarding SPA agreements to clarify the agency’s interpretation of the statutory standard regarding SPA agreements and the rescission of such agreements.”
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