The FDA’s promotional enforcement squad wasn’t very active in 2016—until December, that is. Since the beginning of the month, the Office of Prescription Drug Promotion has cited six drugmakers for overstepping their bounds, more than half of its enforcement actions this year.
The first two of the month, issued to Celgene and Sanofi, addressed television advertisements the agency considered misleading. The medium was traditional; the reasoning potentially worrisome, according to pharma marketing experts. But since then, the agency has focused on digital communications—email, a webpage and two YouTube videos—and at least one of those hand-slaps raises questions about just how far the arm of the FDA can reach.
In an untitled letter dated Dec. 21, posted this week on the agency’s website, the OPDP chastised India-based Zydus for a YouTube video featuring Lipaglyn (saroglitazar), its branded drug for diabetes patients with out-of-balance blood lipids. The product isn’t approved by the FDA, so the agency considers it an “investigational drug,” and touting the supposed advantages of an unapproved product is obviously a no-no.
Thing is, Lipaglyn is approved in India. The FDA acknowledged this, but the agency also said that, by making “broad statements” referring to Lipaglyn as “the world’s first” product of its kind, the video suggests that the drug is, in fact, approved throughout the world—including in the U.S.
And that means the video’s statements about Lipaglyn as a “novel, first-in-class therapy” with a variety of features superior to “other molecules” are verboten. The FDA ordered Zydus to stop violating the Food, Drug and Cosmetics Act and to respond by Jan. 6 with its plans for discontinuing use of the “violative materials.”
In a statement to the Indian Stock Exchange Wednesday, Zydus pointed out that the FDA’s missive wasn’t a warning letter, but an untitled letter, and helpfully explained the difference. “Unlike a warning letter, an untitled letter does not include a statement warning that failure to promptly correct a violation may result in enforcement action,” Company Secretary Upen H. Shah wrote. As for its reaction to the FDA’s move? “We have already taken the necessary actions to respond to this letter,” Shah wrote.
The video is no longer available on YouTube, nor is it found at the Lipaglyn branded website address the FDA cites in its letter.
One of the other three letters also relates to a YouTube video about a drug that’s not FDA-approved: Cinncinnati-based Chiasma’s acromegaly drug octreotide. The difference here is that octreotide isn’t approved anywhere in the world. Chiasma’s mistake, as described by the FDA in a letter also dated Dec. 21, was suggesting that it’s safe and effective, with the agency’s stamp of approval for those statements.
As for the other two, they are warning letters, not untitled letters, and they not only contain the “immediately cease” admonitions in Zydus and Chiasma’s citations, but demands for corrective action plans.
The OPDP zeroed in on Hauppage, NY-based United-Guardian and its bladder drug Renacidin in a Dec. 13 letter. According to the agency, the company distributed an email full of the drug’s benefits—and completely devoid of its risks. The message does include a “click here” sort of link to more Renacidin information, but that link wasn’t enough, the FDA says. The email should have included risk information in the body of the message, too, the letter states.
What’s more, the FDA says that the email made a couple of assertions about Renacidin that lacked any back-up. “No references are cited to support these general claims that Renacidin simplifies long-term care of in-dwelling catheters or is easy to use, and we are not aware of supporting evidence,” the agency says.
The FDA made similar accusations against Salt Lake City-based Spriaso for a webpage touting its cold-and-allergy product Tuxarin ER, which combines the cough suppressant codeine with the common antihistamine chlorpheniramine maleate. The drug comes with a long list of contraindications and serious risks, but the webpage fails to mention any of them, the FDA’s letter says. The page also serves up some misleading claims about Tuxarin’s advantages over its rivals, the agency says.