EU court ruling, FDA move, what do they have in common?
May 13, 2009 – 4:38 pm by ChrisThis was a not-so-pleasant surprise to find first thing Tuesday morning: an EU court ruled that media comment on medicines may constitute advertising. The case involves Danish journalist Frede Damgaard, who wrote back in 2003 on his Website about a natural supplement called Hyben Total, which was initially licensed for the treatment of a wide variety of conditions but was refused marketing authorization by the Danish authorities. The product is authorized in Sweden and Norway, however. Mr. Damgaard was not selling Hyben Total or being paid by the manufacturer to endorse it, yet he was prosecuted by the Danish courts anyway. Mr. Damgaard appealed the ruling, and the European Court of Justice smacked him down. If you want to read the opinions issued by the judges, Ed Silverman posted links in his article about the ruling at the Association of Healthcare Journalists Website. Here is what the judges had to say:
“Article 86 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, is to be interpreted as meaning that dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, may be regarded as advertising within the meaning of that article, even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product. It is for the national court to determine whether that dissemination constitutes a form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.”
So, does this mean that if I write about a drug that is approved, say, in Germany, but has not been approved for that indication in Denmark, or Sweden, or Norway, could my rewrite of a company press release be construed as advertising with the countries where that drug is not approved? Could a feature story that talks about the indications of a drug in a particular market be construed as advertising in a country where that drug is not approved for that indication? If the narrowest interpretation of the ruling is followed, I’d say that’s a yes.
That’s setting up some red flags for me, because as a trade publication, Med Ad News publishes press releases about drug approvals on our Website, Pharmalive.com, and I know we have some readers in the European Union (“some” meaning more than 42,000 people from the United Kingdom, Germany, France, Spain, Italy, Sweden, Norway, and Denmark who visited Pharmalive.com so far in 2009 ). Are we cruising for a lawsuit if we talk about a cancer drug approved in the United Kingdom for one indication, but not approved for that indication in Belgium or Denmark? The EU court does leave it up to individual countries’ courts to determine whether an article can be construed as advertising, but with all the ill will against Big Pharma, anything can happen.
Bureaucracies are crazy entities, after all; look at how the FDA went after Cheerios on Wednesday for making unauthorized drug-like claims. We may see some backpedaling on this, if statements by Peter Pitts, a former FDA associate commissioner, are anything to go by. Blogging at DrugWonks, Mr. Pitts says, “I spoke with senior officials at the agency yesterday who were incensed that the Minneapolis field office sent out this letter. Just another example of the right hand not knowing what the left is doing. Interpret that as you like.”
So, in honor of these two moves being so full of fail, I give you two other things full of fail:
You can go to Failblog for more examples.
