Boehringer Hit for Ad Masking as Press Release
March 19th, 2013 // 3:30 pm @ jmpickett
FDA Hands Out CAPA 483s Like Candy
The drugmaker does not believe so, but the Swedish Medical Products Agency disagrees. And so, the regulator upheld a decision to prevent Boehringer Ingelheim from using a press release about its Pradaxa bloodthinner after ruling a 2011 missive was really an advertisement aimed at the general public, PM Livereports. And direct-to-consumer advertising is not permitted under Swedish and European law.
The release publicized plans to lower the price for Pradaxa in Sweden and was published in May 2011 on mynewsdesk.com, a web site that promotes press releases and is read by journalists. As far as MPA was concerned, though, the release was ultimately desinged to convey the information to the public and, therefore, breached Swedish regulations.
[UPDATE: The Swedish MPA has sent us a copy of its announcement, which appears here in translated form.]
The president of the Swedish pharmaceutical trade association LIF, Anders Blanck, told PM Live that the court has “chosen to completely ignore the clear and long-established practice†of providing journalists with press releases. “We will now analyze the judgment in detail, and may later decide [if] LIF and the company concerned will proceed in the matter.â€
Of course, a press release containing information of this sort for distribution in the US would not be an issue, since direct-to-consumer advertising is permitted. Such advertising has been widely debated in Europe, where the European Commission spent considerable time revising policies concerning publication of drug information. Ultimately, a ban on DTC was maintained (back story).
But the ruling raises a tricky point. On one hand, the press release is purportedly designed so that the information would be conveyed in legitimate media coverage. But the MPA decided the release was mere window dressing. Theoretically, that logic could be applied to any press release. Boehringer argued “established practices†were followed and that such releases were protected as freedom of speech.
We have asked the both Beohringer and the MPA for further comment and will update you accordingly.
