AMRN's letter in response to FDA filings:
Link to various other supporting evidence, includes lots of stuff related to the SPA:
Case 1:15-cv-03588-PAE Document 53-12 is the Type A SPA meeting document.
Doc #67 is Amicus Brief filed by 4 doctors, outstanding reading, tears FDA to shreds:
PRELIMINARY STATEMENT
The approach taken by FDA in this case will be familiar to students of its prior
behavior. It has long been standard operating procedure for FDA to seek to escape from First
Amendment-centered judicial review of its regulations. As Professor Rodney Smolla put it in his
recent assessment of the very body of law that is at issue in this case, “the government appears to
employ a deliberate strategy to avoid making law in this area, using its coercive power to force
settlements or its interpretive power to deftly alter regulatory positions so as to avoid a frontal
First Amendment assault on its position.” Rodney A. Smolla, Off-Label Drug Advertising and
the First Amendment, 50 Wake Forest L. Rev. 81, 84-85 (Spring 2015). 1
In this case, however, FDA’s efforts have been anything but deft. FDA is simply
wrong that almost nothing remains at issue in the case except Amarin’s desire to state, without
risk of criminal prosecution, that “supportive but not conclusive research shows that EPA and
DHA may reduce the risk of coronary heart disease”—the very language that FDA acknowledg-
es would not be false or misleading if Amarin were to “repackage and relabel [its] product as a
dietary supplement.” June 5th Ltr. (“Ltr.”) 10, 12; see also Opp’n 9, 15. That certainly is at issue
(see § II.c, infra) but so is far more.
I. THIS CASE PRESENTS A LIVE CONTROVERSY
Only two months ago, FDA told Amarin in its “Complete Response Letter” that
“if [Vascepa®] is marketed” for off-label use Amarin could face prosecution under the FDCA’s
“misbranding” provisions. Ketchum Decl. Ex. 9. Still more recently, FDA reasserted on the first
page of its June 5 letter to Amarin its authority to pursue “misbrand[ing]” prosecutions for off-
label promotion. It closed the letter with another warning that Amarin risked prosecution if it
uttered its proposed health claim set forth above on page one. Ltr. 10. 5 The government now
claims that Amarin “cannot show a credible threat of prosecution” in light of its June 5 letter.
Opp’n 16. As we have shown above, that statement is inaccurate. Substantial issues of the
highest import remain for judicial resolution. 6
Finally, FDA’s letter does not even purport to bind the Department of Justice and
therefore has no bearing at all on the relief Plaintiffs seek against that entity with regard to its
prosecution of off-label promotion under the False Claims Act.
The FDA and its prosecutors invoke a . . . circularity. There is nothing illegal
about promoting off-label drug uses. But there’s a catch (there’s always a catch).
No drug may be promoted if it is misbranded. Any drug promoted for use other
than a use approved by the FDA (i.e., any drug promoted for an off-label use) is,
by definition, “misbranded.” And much like the military in Catch-22, which
claims it is not penalizing the pilot merely for asking to be grounded, but rather is
simply using “the ask” as evidence of the pilot’s sanity, the FDA claims it is not
penalizing the promoter of off-label uses for the promotion itself, but rather as ev-
idence of misbranding. While seductively clever, the government’s argument is
too clever by half. Here is its flaw: the . . . evidentiary-use principle is valid only
when the elements of the underlying crime or tort do not themselves require ex-
pressive activity. In such cases it is possible to coherently separate the use of
speech as evidence of a nonspeech element from the imposition of liability for the
speech itself. When expressive activity is a necessary element of the crime or
tort, however, no such separation is possible. . . . Unlike the racially motivated
beating in [Wisconsin v.] Mitchell, [508 U.S. 476 (1993),] conduct that was not
intrinsically linked to expression at all, it is impossible to conceive of a prosecu-
tion for the introduction of a misbranded drug into interstate commerce predicated
on the promotion of the drug’s off-label uses without making the expressive pro-
motion of the off-label use an element of the crime.