Replies to post #242055 on Amarin Corp Plc (AMRN)

[lowlevelowl88]

Great post. To my layman's brain this is a very strong argument for the (generic) label promoting inducement, and corroborated by the defendant's witness. Especially where it says when treatment duration should be limited. HELLO. WINNER.

Half expected the last line to be a GIF of Gene Wilder:

OPW - "Prescribe this ONLY for <12 weeks"

From the deposition of Dr. Mathers, one of the expert witnesses for the generics...

Quote:
3 Q. The defendants' proposed labeling does not limit the duration of treatment with the ANDA product and leaves the duration of treatment up to the discretion of the prescriber as well, correct?

A. Correct.

Q. A prescriber would understand that if there were a safety or efficacy reason to limit the duration of treatment, the labeling would state that, correct?

MS. FUNDAKOWSKI: Objection; form.

THE WITNESS: I'm not sure what a prescriber would specifically understand. But certainly in the absence of a warning or limitation, the prescriber would assume that the duration of treatment would be within the prescriber's discretion.

BY MR. SIPES:

Q. And if you look to Paragraph 132 of your report, you quote FDA's regulations of 21 CFR Section 201.57(c)(3)(i)(F). Do you see that?

A. Yes.

Q. And FDA's regulations require that the Dosage and Administration section include, quote, "the usual duration of treatment when treatment duration should be limited." You quote that, correct?

A. Yes.

Q. And neither the Vascepa labeling nor defendants' proposed labeling includes the usual duration of treatment in the Dosage Administration section, correct?

A. That's correct.

Q. Nothing in the Vascepa labeling or the defendants' proposed labeling contains a limitation of use concerning the duration of treatment, correct?

A. Nothing in which section, indications and dosage?

Q. Nothing in the Vascepa labeling contains no -- scratch that. No section of the Vascepa labeling contains a limitation of use concerning the duration of treatment, correct?

A. I believe that's correct.

Q. And similarly, no section of defendants' proposed labeling contains a limitation of use concerning duration of treatment, correct?

A. That's correct.