Today the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) held its first enforcement webinar of 2014, addressing enforcement actions taken in Q3 and Q4 of 2013. These enforcement actions included:
- Q3 2013: Brovana, Dalfampridine (Ampyra), Naftin, Zevalin
- Q4 2013: Aranesp, Benicar, Cedax, Dantrolene Sodium, Diclegis, Juxtapid, Lanoxin, Ribavirin, Soltamox, Vascepa
Enforcement actions were taken related to these products for a variety of reasons, including promotion of an investigational new drug, omission and minimization of risk information, unsubstantiated superiority claims and unsubstantiated or misleading claims. A few highlights from the webinar:
- It was noted that 50% of the warning letters from this time period related to products with a boxed warning. Warning letter also were issued to orphan drugs. The OPDP stated that while it does not target these types of products, it takes a risked based approach to its enforcement activity, in part due to limited resources.
- The OPDP stated that it considers a number of factors when deciding whether to issue an untitled letter versus a warning letter. These factors include repetitive behavior or whether corrective action is needed. One such enforcement action was the Ampyra warning letter issued in July 2013. The OPDP stated that a warning letter was issued in this case because the OPDP previously issued an untitled letter in July 2012 related to similar issues. Further, the omission of serious risk information from the promotional piece required the company to take corrective action. The OPDP responded to a question during the webinar that the promotional piece at issue – a print ad published in a February 2013 issue of the Des Moines Sunday Register – came to the attention of the OPDP through a complaint.
- Several questions were directed to the OPDP during the webinar related to the Lanoxin untitled letter. The OPDP stated that an untitled letter was issued related to the minimization of risk information because certain risk information was located after the signature block and on the second page of a two page ”Dear Doctor” letter. The OPDP explained that this was not a fair and balanced presentation of the risk information that contained numerous efficacy claims on the first page of the letter. Additionally, serious risk information was completely omitted from the letter section and a statement to “Please see full prescribing information including contraindications, warnings, and precautions at covispharma.com under products and then Lanoxin Tablets” did not mitigate this issue.
- The OPDP made it clear that a “Note” in a product’s PI can be “material facts” that need to be included in promotional materials. For example, in the Cedax untitled letter, the OPDP stated that the company’s failure to include a note that in acute bacterial otitis media, Cedax’s “efficacy against Streptococcus pneumoniae was 23% less than control” rendered the product’s website false or misleading because it omitted risks and material facts associated with use of Cedax. The OPDP also raised concerns that images of children clearly younger than 12 years of age were being used on the website.