Replies to post #60247 on Amarin Corp Plc (AMRN)

[jessellivermore]

Will...

Have you even bothered to skim this opinion by Moss?

It does absolutely nothing to support your notion..

For beginners, The Eisai hearing involved a situation where Eisai was suing the FDA because of the requirement of their drug to get a "scheduling"determination from the DEA (Drug Enforcement Agency) which classifies certain drugs which have addiction potential.

The fact the DEA determinations occur after the FDA date of approval shortens the exclusivity periods mandated by congress because the company can not market the drug until the DEA makes it determination and that can take some time..Eisai felt that was unfair and discriminatory.

The FDA argued successfully that congress understood there could be delays in marketing and could have used other methods to determine the exclusivity period which took these factors into account, but chose not to because it would have created a regulatory mess.

FDA argues Eisai was not being discriminated against, because the same rules applied to all drugs requiring DEA classification and none of these received additional exclusion time outside of the regulations.

"More relevant to the FDA’s consistency is the fact that it has always treated drugs
awaiting DEA scheduling in the same way it treated Belviq and Fycompa here. The record
reveals 11 drugs approved since 2005 that were subject to DEA scheduling determinations. See
AR 157. In none of those cases did the FDA delay the beginning of the exclusivity period until
after the drug had been scheduled."

The FDA's sole exclusion to the H-W exclusions are drugs that the FDA approves (by letter) which call for further FDA actions before the drug can be marketed. In one case was the FDA demanded the company change the name of the drug before marketing it. In these cases the drug approval letter is conditional on an action and the FDA begins the exclusion and the marketing on the same day.

Specifically Moss says the requirement to obtain approval of a label change is insufficient to trigger an exception.

Eisai was not a triumph for the company. Judge Moss denied Eisai's claim and granted a summary judgement for the FDA..

Apology accepted...":>) JL