ile this under “What were they thinking?”
At a time when selling opioid painkillers is fraught with challenges, two companies committed an unnecessary blunder. The US Food and Drug Administration decided that Pain Therapeutics and Durect were jointly touting an experimental drug on their web sites in a way that appeared so misleading that the agency issued a rare letter to criticize their marketing practices.
According to the Sept. 8 letter, which the FDA posted on its website this week, the companies made statements that consumers might construe to mean the drug, Remoxy ER, is already approved for use. The agency pointed to certain language on the company websites — such as “long-acting” and “tamper-resistant” — that gave the impression these were “established facts” pertaining to an approved drug.
Moreover, the FDA believes the impact was magnified because the websites failed to clearly note that Remoxy ER is not yet approved, and referred to the medicine by the commercial name that would be used to market the treatment. And the agency complained that the design of the websites makes it difficult to find any of the few references to the experimental status of the drug, which is a form of oxycodone.
We asked the companies for comment and will pass along any replies that we receive.
Such a gaffe comes at an inauspicious time. There is intensifying concern over the use and misuse of such drugs. Every day, more than 40 Americans die from overdoses of opioid painkillers, according to the Centers for Disease Control and Prevention. And each year, 2 million people abuse or misuse the drugs. As the FDA wrote to the companies, “the current opioid abuse epidemic is a critical public health matter.”
At the same time, drug makers have been widely criticized over the years for their promotional practices. Many of the largest companies have been accused of using deceptive marketing that downplayed risks and improperly encouraged physicians prescribing that caused some patients to become addicts. Such moves included using front groups to support wider use for combating pain.
By contrast, the website issues cited by the FDA may seem minor. But given the climate in which opioid marketing is viewed, the letter is notable. Interestingly, the letter was sent just as the companies hope to finally win FDA approval for Remoxy ER. The agency is expected to decide by Sept. 25, although there is nothing to suggest the website issues will have any bearing on the decision.
We should also note that this is only the fourth letter that the FDA has issued this year to cite marketing infractions. As we have reported previously, the agency issued just nine letters in each of the past two years — which not only represented an all-time low, but was also well below the 52 letters that were sent to companies in 2010.
There are differing views about the reason for the falloff.
John Driscoll, a regulatory affairs consultant, suggested the small number of letters may reflect FDA sensitivity toward cracking down on certain marketing while the agency sorts out free speech challenges from companies. And Mark Senak, who writes the EyeOnFDA blog, speculated the decline may be due to a transition phase as the agency works on industry guidelines for social media promotions.