This week FDA’s Office of Prescription Drug Promotion (OPDP) posted what was only the second enforcement letter of the year which was issued in May. Warning letters are issued by many parts of the FDA, but OPDP issues letters squarely aimed at the communication by pharmaceutical companies about the medicines they market. Twenty years ago such letters were issued with ferocious frequency, numbering over 150 at their peak. So far this year, there are two.
At least part of the reason for the drop-off has been a change in focus by the agency to be more risk-based in the expenditure of time, resources and effort – something former Commissioner Gottlieb felt strongly about. That has extended to OPDP which used to issue a letter for a technical infraction of communications boundaries that would not have really had an impact from a public health perspective, but are more prone to act now only where the agency sees infractions that are violations where there is a potential for some kind of harm.
That has meant, as noted here in past postings, that there has been a concentration on two types of violations. First, the presentation of risk information. And second, a focus on the promotion of unapproved products.
The most recent letter falls in the former category. There are two types of letters – Warning Letters reserved for situations FDA regards as more serious, and Untitled Letters for those considered less so. The letter issued this week was an Untitled Letter, sent to VIVUS for website content for the weight loss drug Qsymia. The letter was issued almost 15 years to the day that the company received their only other letter from OPDP (then DDMAC) back in 2004.
The letter regarding the Qsymia website addressed the presentation of benefit and risk information related to the product. Noting that obesity is an extremely common condition for which people are seeking help and that the drug itself had several limitations associated with its use and serious potential risks, the agency took issue with the balance between the benefit information presentation versus the placement of the risk information on the site. In addition, a claim that the drug worked three times faster than diet and exercise alone was cited by FDA as being a claim that was without support because the data cited for support calculated the amount of weight lost, but not the rate of the weight loss itself.
In addition to the risk information, OPDP addressed the treatment of benefits for the drug. The agency said that the patient data utilized in the discussion of benefits did not factor in the substantial number of patients who withdrew from participation in the clinical trials, which the agency deemed a selective presentation of results that resulted in overstating efficacy.
As stated above, this is only the second letter of the year. The prior one was directed at communication deemed to be pre-approval promotion. These are the two areas which seem to be the focus of the agency. While this letter dealt with obesity, the prior letter dealt in a product used in imaging related to treatment of oncology patients. Neither product had a boxed warning on the label, meaning FDA’s focus on areas where they consider a health implication to the violation is not confined to products with such labels. By OPDP standards, the year is still young and it is possible we could see more letters this year, but look for them in areas of risk information and promotion of an unapproved drug or use.