J&J Warned By FDA Over Remarks By Sales Rep
January 12th, 2012 // 1:37 pm @ jmpickett
You know the old adage to be careful about what you say? This is a golden rule that sales reps should remember, especially when participating in discussions at industry gatherings. We say this because the FDA has just released a letter to a Johnson & Johnson unit over remarks made by an employee, who was accused of promoting a drug for an unapproved use and minimizing various risks.
To wit, FDA staffers from the Division of Drug Marketing, Advertising and Communications witnessed statements made by an Ortho-McNeil-Janssen rep on December 8, 2010, at the American Society of Health-System Pharmacists clinical meeting and exhibition in Anaheim, California, about the Nucynta med, a pain reliever which was approved last in August 2008 for use in anyone who is 18 years or older.
That day, a J&J rep sales representative indicated that Nucynta would be useful in treating Diabetic Peripheral Neuropathic Pain, but the med was never approved specifically for that malady. The rep also said that DPNP patients can stay on Nucynta longer, and the med offers as much pain relief as oxycodone, but with fewer gastrointestinal reactions, such as constipation, nausea and vomiting.
Yet, the FDA notes, the most common side effects associated with Nucynta during clinical trials included nausea and vomiting; these were also among the most common reasons for discontinuing treatment. And 8 percent of Nucynta patients had constipation in studies compared with 3 percent who were given a placebo. Also, there were never any head-to-head trials with the other meds.
Two other points made by the FDA – the rep maintained Nucynta saves docs from using the other treatments and patients can cut their hospitals by a day, which would save thousands of dollars because they will be able to go home and poop. But there is no evidence to back up any of these assertions, according to the agency.
The remarks by the rep were made more than a year ago, and the FDA issued the letter to J&J last August. But the substance, tone and relevancy of the agency admonishment are worth noting, given the recent release of a draft guidance on how drugmakers should respond to unsolicited requests for off-label information (read more here).
Unfortunately, it is not clear from the FDA letter whether the J&J rep made the remarks in response to an unsolicited request, but this may have been the case, given the circumstances. And so the letter may offer a blueprint, in so far as the FDA uses a rather broad interpretation of what was considered to be off label and the DDMAC staffers were also rather strict in analyzing comparative claims (here is the letter).
[UPDATE: A J&J spokesman later sent us this note: “We expect our employees to comply fully with all FDA promotional guidelines, and with all federal and state regulations. We have provided FDA with a timely reply and have taken appropriate corrective action to address the situation.”]
