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Last month, Amarin Pharma, Inc. filed a complaint in the Southern District of New York asserting that the FDA could not apply its regulations to prohibit or criminally prosecute Amarin’s proposed communication of truthful, non-misleading information as to off-label uses of Vascepa, a drug that the FDA had approved to treat very high, but not high, triglyceride levels.  Amarin claimed that such regulation would violate its First Amendment commercial speech rights.  We blogged about it here.

Since then, Amarin has moved for a preliminary injunction.  The content of Amarin’s supporting brief is both unsurprising and convincing.  It laid out the truthful, non-misleading statements that it wanted to provide to healthcare providers:

  • Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.
  • The ANCHOR trial demonstrates that Vascepa® lowers triglyceride levels in patients with high (≥ 200 mg/dL and <500 mg/dL) triglyceride levels not controlled by diet and statin therapy.
  • In the ANCHOR trial, Vascepa® 4g/day significantly reduced TG, non-HDL-C, Apo B, VLDL-C, TC  and HDL-C levels from baseline relative to placebo in patients with high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels not controlled by diet and statin therapy.  The reduction in TG observed with Vascepa® was not associated with elevations in LDL-C relative to placebo.

It also wanted to hand health care providers the results of its ANCHOR clinical trial as well as other peer-reviewed articles on clinical trials addressing the connection between EPA (Vascepa’s active ingredient) and coronary risk.  It proposed to caution health care providers that (i) the FDA had not approved Vascepa to reduce coronary risk or to treat mixed dyslipidemia and high triglycerides, (ii) Amarin was conducting an ongoing cardiovascular outcome study, and (iii) the costs of Vascepa may not be reimbursed by government programs.

Amarin argued, however, that it could not safely communicate this truthful, non-misleading information because the FDA had it under the threat of criminal prosecution.  Yet the FDA’s enabling statute, the FDCA, says nothing about a ban on off-label promotion.  Moreover, Amarin argued, while the government certainly has a public interest in promoting drug safety and public health, the FDA could easily find more effective, less-restrictive means of achieving that purpose other than prohibiting truthful, non-misleading off-label speech.  Amarin cited repeatedly, as it should have, to the Second Circuit’s Caronia decision.

The FDA must file a responsive brief, but it hasn’t yet.  Instead, it gave a surprising response.  It sent Amarin a letter.  It did this even though Amarin had not filed an administrative request.  The letter, which reads like an effort by the FDA to moot the matter and protect its ground, says, in essence, “Whoa, whoa, whoa. We don’t want a fight.”

In particular, it said that the FDA “does not have concerns with much of the information [that Amarin] proposed to communicate.”  It argued that this position is already clearly laid out in its reprint guidance documents from 2009 and 2014.  Under guidance in those documents, the FDA claimed that Amarin could distribute the ANCHOR clinical trial results through peer-reviewed articles.  Separately, the letter said that Amarin could communicate summaries of those trial results – like the summaries Amarin proposed in its complaint and opening brief – but Amarin should not do so in marketing materials or via sales reps.  It also suggested that Amarin could make the following statement about Vascepa:  “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”  But not if Vascepa was still a drug.  Amarin would simply have to repackage and relabel Vascepa, distribute it as a nutritional supplement, and then it could go right ahead and make that statement.  The FDA cited the differences in the regulatory regimes for drugs and nutritional supplements as the basis for its reasoning.

There are obviously problems with this.  FDA guidance documents are often anything but clear.  And their purpose is uncertain.  Can they be relied upon?  They are not statutes.  They are not regulations.  Many times, they aren’t even final.  Their cover pages often state that they are drafts.  That doesn’t appear to be a clear means to issue guidance on something as important as commercial speech restrictions, particularly with criminal prosecution hanging in the balance.  The need for the letter itself seems to highlight the insufficiency of the FDA’s guidance and regulations.  Beyond that, the FDA letter continued to suggest that the FDA intends to prohibit communication of truthful, non-misleading information in promotional material involving sales reps.  Didn’t Caronia already solve that?  (Does anybody hear a Supreme Court argument being teed up?)  And the FDA’s absolute prohibition on Amarin communicating evidence suggesting a possible connection between EPA and reduced coronary risk, while allowing Amarin to nonetheless say exactly that if it simply repackages Vascepa as a nutritional supplement, raises more questions than it answers.

Well, Amarin hasn’t responded yet.  In fact, the FDA hasn’t even filed its responsive brief.  Instead, it asked the court for more time (please excuse the link to a message board, but it works), relying on, among other things, the responses to its letter, and other arguments, raised in a number of subsequent amicus briefs:

The amicus briefs, which together represent 72 pages of briefing, raise a number of arguments not presented by Plaintiffs, including the following: (i) health payers need information about unapproved uses of drugs; (ii) FDA’s application of its authorities and policies restricts information about on-label uses of drugs; (iii) FDA’s application of its authorities and policies should be subjected to heightened scrutiny; (iv) the language of FDA’s regulations is impermissibly ambiguous, and FDA’s guidance documents do not cure this purported ambiguity; (v) FDA is improperly attempting to avoid providing guidance to the pharmaceutical industry about the types of communications at issue here; and (vi) FDA improperly distinguishes between promotion and scientific information. The Government continues to assess the amicus briefs— while also preparing its brief and supporting papers for filing on June 18—and has not yet made a determination as to its position, if any, on the issues raised by the amici, nor has the Government determined the extent to which it must address these additional issues. In order to allow the Government sufficient time to consider these numerous new legal issues and to more carefully respond to Plaintiffs’ motion, the Government respectfully requests a two-week extension of time to file its opposition to Plaintiffs’ motion for preliminary injunction.

The FDA wants until July 2 to file its brief.  Then we’ll get a response from Amarin.  We’ll continue to follow this, including an upcoming post on the various amicus briefs and, ultimately, the parties’ final briefing.  We told you this would be interesting.