FDA Drug Promotion Enforcement Update

It has been an interesting week from the perspective of an FDA drug promotion attorney. On the one hand, we have a federal district court expanding how drug companies can promote drugs; on the other, we have FDA’s Office of Prescription Drug Promotion (“OPDP”) issuing its first genuine Warning Letters in almost 10 months. Here, we provide a quick update of what the courts say you can do, and what FDA says not to do.

What the Court Says Drug Companies Can Do

As you may be aware, last week, the U.S. District Court for the Southern District of New York handed down its opinion in Amarin Pharma, Inc. v. FDA (“Opinion”), granting Amarin Pharma, Inc. (“Amarin”) a preliminary injunction prohibiting FDA from taking enforcement action arising from certain off-label promotion of Vascepa. Vascepa is a fish oil-derived drug approved by FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. After receiving its initial approval, Amarin conducted a study to support premarket approval for a supplemental indication to treat patients with persistently high triglycerides. FDA took issue with the study outcomes, requested additional supportive data, and warned Amarin that marketing the drug for the proposed supplemental indication would amount to “misbranding.”

In its complaint, Amarin claimed that FDA’s threat of enforcement action had a chilling effect on constitutionally protected truthful speech and went so far as to propose various off-label statements and risk information that it intended to communicate to healthcare providers.   Ultimately, the court agreed with Amarin’s First Amendment arguments, relying primarily on the Second Circuit’s U.S. v. Caronia opinion, which is binding on the Southern District of New York. The court held that “under Caronia, the FDA may not bring such a [misbranding] action based on truthful promotional speech alone, consistent with the First Amendment.” Opinion at 45.

The court acknowledged and rejected the Agency’s argument that it must be allowed to regulate off-label speech regarding drugs, even if truthful and non-misleading, in order to protect the integrity of the approval process. The court stated that the 1962 legislation creating the existing drug-approval scheme simply “predates modern First Amendment law respecting commercial speech.” Opinion at 49.

Although Amarin stands as a significant post-Caronia case, it is important to keep in mind that the cases are limited to the Second Circuit and that this is a ruling on a preliminary injunction. FDA may appeal the district court’s ruling, or press on with the litigation in the district court.

What OPDP Says Drug Companies Cannot Do:

Though OPDP has issued numerous untitled letters in the last year, its recent Warning Letters against ECR Pharmaceuticals and Duchesnay, Inc. are the Agency’s first in nearly a year. In both Warning Letters, OPDP cites the companies for failing to provide adequate risk information, among other things. The letter to Duchesnay, Inc. has the added novelty of addressing social media posts made by celebrity Kim Kardashian.

The Duchesnay Warning Letter involves social media posts Ms. Kardashian made to promote Diclegis (doxylamine succinate and pyridoxine hydrochloride), an anti-nausea medication.   Diclegis is approved for the treatment of nausea and vomiting in pregnant women who do not respond to conservative management. Ms. Kardashian posted a testimonial to her Facebook and Instagram accounts (with links to her Twitter account):

OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com.

FDA objected to the post because it included no risk information at all for Diclegis – an omission that was not cured by providing the statement and link, “find out more www.diclegis.com; www.diclegisimportantsafetyinfo.com.”

Popular media reports have focused upon Ms. Kardashian, and, certainly, being prominently featured in an FDA Warning Letter would be embarrassing for a celebrity endorser. FDA’s actions, however, are limited to Duchesnay, the company sponsoring the communications and holding the approved application for Diclegis. FDA’s more limited action contrasts with the Federal Trade Commission, which routinely pursues both product advertisers and their endorsers.

The second Warning Letter involves an ECR Pharmaceuticals, Inc. sales aid for TussiCaps® (hydrocodone polistirex and chlorpheniramine polistirex). TussiCaps® is approved for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older. The 4-page sales aid was misleading because it included numerous efficacy claims for TussiCaps®, but, like Ms. Kardashian’s social media post, failed to include any risk information about the product. FDA took particular issue with the sales aid because it included a picture of a child without mentioning that TussiCaps® is contraindicated for children less than 6 years of age due to risk of fatal respiratory depression. Moreover, FDA objected to comparative claims that patients prefer TussiCaps® to liquid dosage forms and rejected the data the company offered in support of that claim.

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Although the Amarin opinion appears to expand the ability for drug companies to provide truthful information about their products, the OPDP Warning Letters reinforce that that those claims must still not be misleading and must be accompanied by appropriate risk information.

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