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

Health Letter, June 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.

On May 7, Amarin Pharma filed an unusual lawsuit against the Food and Drug Administration (FDA), arguing that the agency’s drug regulations violate the company’s First Amendment free-speech rights.[1] If Amarin prevails in its litigation, the repercussions for patient and public health will be dire.

Under current laws — which have been in place for more than 50 years — a drugmaker must obtain FDA approval to market a drug for each specific use for which the drugmaker intends to sell it. FDA experts review the evidence submitted by the company to support the proposed uses and then determine whether the drug is safe and effective for those uses. As part of this process, the FDA reviews and approves the drug’s labeling, which must list each approved use. Federal law prohibits companies from promoting drugs for any other uses, a practice called off-label promotion. (For years, drug companies routinely have violated this law.)[2]

In recent years, pharmaceutical companies increasingly have campaigned against the law’s limits on drug promotion, arguing that under the First Amendment, companies have the right to distribute truthful information about unapproved uses. The Amarin lawsuit represents the latest salvo in this campaign.

Amarin wants to be allowed to distribute information regarding unapproved uses of its fish oil drug, icosapent ethyl (VASCEPA).[3] The drug was approved by the FDA in 2012 for treating patients with extremely high levels of blood triglycerides,[4] a type of fat associated with increased risks of heart disease and pancreatitis. The company later sought FDA approval for a different use — to treat less severe elevations of blood triglycerides in patients with heart disease or high risk of heart disease — but the agency rejected the company’s application for this use because of a lack of evidence of effectiveness. Amarin now is asking a federal court to allow it to distribute to physicians information about this rejected use.[5] Amarin’s lawsuit represents a transparent attempt to bypass the FDA’s drug approval process and the prohibitions against off-label promotion.

The First Amendment’s free-speech right is not absolute. It is subject to a balancing test that weighs the speech right against the public interest in restricting the speech. In the case of commercial speech regarding drugs, free-speech rights are balanced against the government’s interest in protecting patient and public health by not allowing companies to market drugs for unsafe or ineffective uses.

If Amarin wins its lawsuit, it will fundamentally undermine the FDA’s gatekeeper role for ensuring that drugs are safe and effective. It is imperative, therefore, that the FDA aggressively defend against the company’s lawsuit and that the court reject the company’s claims.


[1] Silverman E. Drug maker sues FDA over free speech right to promote off-label. The Wall Street Journal. May 7, 2015. http://blogs.wsj.com/pharmalot/2015/05/07/drug-maker-sues-fda-over-free-speech-right-to-promote-off-label/. Accessed May 16, 2015.

[2] Public Citizen. Pharmaceutical Industry Criminal and Civil Penalties: An Update. September 27, 2012. https://www.citizen.org/sites/default/files/20731.pdf. Accessed May 16, 2015.

[3] Complaint at 1-2, Civil Action No. 15-cv-3588 (PAE) (S.D.N.Y. filed May 7, 2015)

[4]Amarin Pharma Inc. Label for VASCEPA (icosapent ethyl). http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s009lbl.pdf. Accessed May 16, 2015.