Regulatory Focus™ > News Articles > OPDP Plays Santa to Amarin and Covis, but Adds Both to 'Naughty' List for Promotional Problems

OPDP Plays Santa to Amarin and Covis, but Adds Both to 'Naughty' List for Promotional Problems

Posted 20 December 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) may be slowing down a bit as the Holiday season fast approaches, but its advertising regulators at the Office of Prescription Drug Promotion (OPDP) haven't yet done the same, and have added two more companies to its "naughty" list after reviewing their promotional materials.

On 19 December 2013, OPDP announced that two companies, Amarin Pharmaceutical and Covis Pharmaceuticals, had both been sent Untitled Letters over materials the companies has separately used to promote their respective drugs.

Untitled Letters are less serious than Warning Letters in that they do not threaten further enforcement action, but they are meant to demand that the company bring its materials into compliance immediately.


The letter to Amarin references Vascepa (icosapent ethyl), a drug approved as an adjunct to diet to reduce triglyceride levels in patients with severe hypertriglyceridemia, a condition marked by excessive triglycerides in the body.

FDA charged that an invitation to a webcast series for Vascepa had neglected to include the drug's complete risk information, and had instead included only a short "indication and limitations of use" section.

"The print invitation is misleading because it presents efficacy claims for Vascepa but fails to communicate any of the risks associated with its use," FDA wrote. "By omitting the most serious and frequently occurring risks associated with the drug, the print invitation misleadingly suggests that Vascepa is safer than has been demonstrated."

While the invitation contained a disclaimed that readers should see the "full Prescribing Information for Vascepa," FDA contends that this was inadequate.


The Covis letter, by contrast, is considerably lengthier, highlighting a wide range of alleged violations.

OPDP said a promotional piece by Covis-sent in conjunction with TOPS Pharmacy in March 2013-regarding Lenoxin (digoxin), a heart failure drug, failed to meet three regulatory requirements.

The first problem, OPDP charged, was that the letter failed to list adequate risk information. The letter talks at length about the purported benefits of Lenoxin, but fails to mention most side effects or contraindications. And, like the Amarin letter, it omits the full Prescribing Information (PI) and other information found in the Warnings and Precautions section of the drug labeling.

"Furthermore, the letter is misleading because it presents some of the most common adverse events of Lanoxin, such as 'gastrointestinal and cardiac disturbances,' but completely omits other significant common adverse reactions associated with the drug," FDA alleged.

In addition, FDA said the letter included misleading superiority claims stemming from the company's claims that Lanoxin was therapeutically superior to other versions of digoxin by virtue of its manufacturing practices. FDA said this appeared to be unfounded based on its assessment of the therapeutic equivalence of other products it has reviewed.

"Unless and until the Agency's determination is changed or reversed, any promotion suggesting a lack of equivalence between Lanoxin and products deemed to be therapeutically equivalent are considered false or misleading," FDA wrote.

Finally, FDA said statements within its promotional material had served to broaden its intended patient population, and that it had used an outdated version of its product labeling at the time of dissemination-an extremely unusual violation not often seen in OPDP's Untitled Letters.

Both Amarin and Covis were asked to bring their materials into compliance immediately and to explain their plans to discontinue the materials.

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