I will try to persuade FTC to institute an enforcement action against two generic companies, their PBMs and insurance companies.
Details on facts and law I will rely on are set forth in the Petition for Writ of Certiorari that Amarin shareholders filed in the Supreme Court from a CAFC judgment entered on February 15 2022. Importance of case is highlighted by the fact that persons die from CVD every 38 or 40 seconds. Health of American population is at risk for some reasons set forth below.
Note there is an already extant suit filed by Express Scripts and CVS against FTC pending in W. D. Missouri where the high costs of drugs to consumers that are on pharmcy shelves and formularies are at issue. FTC Chair said in July 2024 and again recently on national network TV that FTC intended to investigate those high costs. I have evidence that I think will support the FTC allegations. The relative higher cost of brand Vascepa vis a vis generic products is directly related to the deceptive and misleading conduct, collusion and fraud on a Nevada District Court by two specific generic companies in a post trial brief before that Court that resulted in an erroneous opinion and judgment entered on March 30 2020. The drop in Amarin share price subsequent to that date is also directly related to the fraud and inequitable conduct of the two generics in that Court. Higher tariffs on those imported generic products is one remedy. An exclusion order that would prevent marketing and sale of those generic products is another remedy. Damages from those generics related to or equal in value to that drop in Amarin share price from March 30 2020 to date is another remedy.
Note carefully the opinion and observations re Hikma generic product by CAFC Judge Lourie entered on June 25 2024 and by the Court on October 17 2024 in Amarin v. Hikma. The Court observed that there was no evidence that the FDA had approved any label or ANDA of Hikma for use of its generic product for a CVD use or treatment. The Court also observed the lack of evidence that Hikma's generic product is therapeutically equivalent to the brand Vascepa. Those two observations, besides the fraud on the Courts, raise legitimate questions whether those 2 generics should be competing in Amarin's markets at all.
See also subsequent proceedings in the Supreme Court by Hikma and Amarin.
Finally, no Court has expressed any rational opinion on the facts and law set forth in the above Amarin shareholders Petition for Writ of Certiorari.
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