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Outrage of the Month: Initial Ruling in Industry Lawsuit Threatens FDA’s Regulation of Drugs

Health Letter, September 2015

By Michael Carome, M.D.


If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

In my June column, I expressed alarm about a lawsuit filed in May by Amarin Pharma against the Food and Drug Administration (FDA). In its lawsuit, Amarin argues that the agency’s regulations violate the company’s First Amendment right to free speech by barring it from distributing information promoting its prescription fish oil drug for uses not approved by the FDA.[1] I maintained that if Amarin prevailed in its litigation, it would fundamentally undermine the FDA’s ability to ensure that drugs are safe and effective for each marketed use.

Unfortunately, Round 1 of this closely watched legal battle went to Amarin: On Aug. 7, U.S. District Judge Paul Engelmayer in Manhattan ruled in favor of the company and issued a preliminary injunction against the FDA.[2] Pending a final ruling, the injunction bars the agency from blocking efforts by Amarin to market its fish oil product for off-label (unapproved) uses, so long as the company’s communications are truthful and not misleading. Although his ruling is only preliminary, the judge signaled that the company likely will prevail in the lawsuit.

In a legal brief submitted on June 23, the FDA’s attorneys presented a cogent rebuttal to Amarin’s First Amendment arguments and outlined in detail the threat posed to public health if the judge were to rule in the company’s favor, declaring:

“This suit is a frontal assault by Plaintiffs on the framework for new drug approval that Congress created in 1962. … Plaintiffs’ legal arguments strike at the very heart of the new drug approval process.”[3]

In his ruling, Engelmayer gave short shrift to the government’s compelling interest in protecting patient health by not allowing companies to market drugs for unapproved uses. Indeed, using disturbingly broad language in rejecting the government’s arguments, the judge suggested that the long-standing statutory and regulatory framework regarding the promotion of drugs may be unconstitutional and trumped by modern interpretations of the First Amendment as it applies to commercial speech by companies.[4]

Assuming that the judge affirms his position in his final ruling and the FDA decides not to appeal (or appeals and loses), this decision represents a major victory for Amarin and the pharmaceutical industry more broadly. For patient and public health, on the other hand, this outcome represents a dangerous loss that threatens to return us to the days of the late 19th and early 20th centuries, when snake-oil salesmen touted “remedies” that were too often ineffective – and sometimes dangerous.


[1] Case No. 1:15-cv-3588-PAE (S.D.N.Y. filed May 7, 2015).

[2] Case No. 1:15-cv-03588-PAE, Document 73, Opinion & Order (S.D.N.Y. filed August 7, 2015). At 2.

[3] Case No. 1:15-cv-03588-PAE, Document 51, Memorandum of Law in Opposition to Plaintiffs’ Motion for Preliminary Injunction ((S.D.N.Y. filed June 23, 2015). At 13.

[4] Case No. 1:15-cv-03588-PAE, Document 73, Opinion & Order (S.D.N.Y. filed August 7, 2015). At 49.