Warning letters most often stem from missing risk information
So far this year, there have been four enforcement actions issued by the FDA, two of which were related to promotions on a digital platform.
The FDA is more concerned about the content and message, and not the medium being used, when it comes to regulating pharmaceutical communications, a Johnson & Johnson executive said Thursday at Digital Pharma East in Philadelphia.
“We often hear that regulatory/legal is opposed to utilizing innovative techniques, or is scared of going on social media,” said Upasana Marwah, Johnson & Johnson's regulatory compliance lead for regulatory advertising and promotion. “That's not the case. [The Office of Prescription Drug Promotion's] mission is to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated.”
The number of warning and untitled letters issued by the FDA this year is significantly lower than in previous years. So far this year, there have been four enforcement actions issued by the FDA, two of which were related to promotions on a digital platform. That's down from nine enforcement actions in 2014 and nine in 2015, 24 in 2013, and 28 in 2012.
Of the two digital-related enforcement actions issued this year, the the FDA's OPDP sent its first untitled letter of the year to Pfizer subsidiary Hospira in January, claiming that the drugmaker published the video without submitting it for OPDP review and misbranded its sedative, Precedex, by omitting risks and material facts in a promotional YouTube video for the drug.
“The FDA stated that the company went into great detail about efficacy, the benefits, how to use the product, but failed to include any risk information associated with the product,” said Marwah. “What's more, they characterized arousability as a benefit of the product as its difference from its competitor, but if you look at the approved prescribing information, arousability is a warning associated with the product, not a benefit.”
When it comes to the allegation of omission of material facts, the video discussed only part of Precedex's approved indication.
“The video goes into detail about how this product can be used in the intensive care unit setting for sedation, which is part of the approved indication,” said Marwah. “However, it failed to include a critical part of the indication, which is that Precedex is to be given as a continuous infusion for no more than 24 hours. If you're a doctor watching this video, that is a critical piece of information you should know when you're treating a patient.”
Another example she points to is an untitled letter that the OPDP sent to IBSA Institut Biochimique in 2014 regarding the Swiss drugmaker's Facebook page for hypothyroidism drug Tirosint. The letter alleged that the content on the Facebook page was false and misleading because it made representations about Tirosint's efficacy but failed to include risk information or facts.
“When we look at the allegation of omission of risk information, the letter states that the Facebook page has a prominent claim on it saying that if you've recently been diagnosed with hypothyroidism or are having trouble controlling your levothyroxine levels, talk to your doctor about Tirosint, a new unique gel capsule for levothyroxine,” said Marwah. “However, there is no mention of any safety information, and what makes this even more concerning is that this product is associated with a boxed warning.”
Boxed warnings are associated with potentially fatal risks. “But if I'm a consumer looking at this Facebook page, there's no way of me knowing that there is a box warning associated with this product, nor is there any way of me knowing what the potential side effects or risks could be,” she said.
Marwah said there were three overarching themes when categorizing the allegations cited in the enforcement actions between 2013 and 2014 — drugmakers omitted risk information, as cited in 75% of the letters, omitted material facts, and the materials lacked substantial evidence, meaning randomized clinical trials that support claims about a drug's efficacy.
“Risk information is critical because it can pose a risk to public health,” said Marwah. “And what this regulatory fundamental gets back to is that if you're including efficacy and benefit information, you must balance that with safety and risk information.”
The themes apply to all promotional materials regardless of the medium, said Marwah. “It's really the message that we're looking at.”
Jack Scannelli, head of regulatory advertising and promotion at Novartis, added that pharma companies should consider factors like whether the material is branded or unbranded, who owns the assets, and how to align a review process and submit to the FDA when using social-media platforms to market their therapies.