Patients, Meet Your Drugmakers
Just when the US is cracking down on direct-to-consumer advertising, the EU seems to be widening its door to drugmaker-patient contact. The European Union’s Pharmaceutical Forum endorsed a proposal last week that could give pharmaceutical companies more direct access to consumers by easing marketing rules and allowing them to provide to the public more information on medical conditions along with treatment option information (i.e., touts for their products).
The European Commission established the forum in June 2005 to examine the competitiveness of the European-based pharmaceutical industry and related public health issues. Although the forum advised that the ban on advertising of prescription medicines continue, the EU’s tight system may be loosening overall.
Here’s why: The proposal that the forum endorsed was sparked by pushes from industry and patient groups for more information on drugs. In the age of the Internet, they argued, the public has access to a wide range of information, much of which is inaccurate. They therefore called for more reliable medical advice from all parties, including pharma companies. The forum seems to have agreed with these ideas. Furthermore, the adopted proposal is very similar to draft legislation to be published this month by EU Enterprise and Industry Commissioner Gunther Verheugen, according to an Oct. 3 article in the Financial Times (FT). That legislation would allow drugmakers to communicate “objective and unbiased” information on their drugs’ uses, side effects, and prices to the general public in written form and on the Internet. If passed, this legislation, along with the forum’s endorsement, greatly widens the door leading to direct-to-consumer advertising in the EU.
The legislation may not be approved too soon given that European parliamentary elections are taking place next year, but there seems to be some momentum for the idea now that the forum has endorsed similar language, says FT.
Back in the US, FDA recently issued five regulatory letters to ADHD drug manufacturers regarding their promotional materials to patients. Eli Lilly received a letter for its ADHD drug, “Strattera,” based on materials that seem to broaden the drug’s indications to include anxiety. Other companies to get letters for taking their advertising too far with regard to ADHD treatments were Mallinckrodt, Johnson & Johnson, Shire Pharmaceuticals, and Novartis.
The US has allowed direct-to-consumer advertising for some time, with much criticism from public groups both inside and outside the country. I’m surprised to see the EU following our footsteps-or rather, missteps-in this area.