Looking To Europe

On my computer home page I noticed a headline regarding off label drug use. I went to the story which was a commentary from Forbes.com. The opinion was authored by two men, one a physician and former FDA official, the other a fellow at what appears to be a Washington Think Tank.

They were against the FDA regulation that forbids a company from marketing a drug for an indication other than what it was approved to treat. This has been discussed in my blog pages many times. I am against off label marketing and in support of the FDAs scrutiny of it. It found it ironic that I wrote about the new Bad Ad initiative with regard to drug marketing just a few days before the Forbes article was written. The new FDA program isn't specifically addressing off label marketing, but misleading marketing.

Still I read the article on Forbes with the hopes of keeping an open mind. The gentlemen argued that the restriction from the FDA was so tight that patients might suffer. Well, you know how easy it is to rile up the public. "The Government is deciding your medical care." The argument from their perspective is that the drug companies are hamstrung because any communication about an off label use could get them fined. This keeps physicians in the dark about new uses for a medicine and could conceivably prevent a patient from receiving an adequate or better treatment.

I see it differently, however, and they did not sway me. The drug companies must test their chemicals or biologics and apply for approvals. The clinical trials should be, and I hope that they are, rigorous. The trials test things like dose, efficacy and side effects. I just don't think that this step should be skipped (but I am in favor of an abbreviated application for new uses of an approved drug). If a drug company wants to market for another use then, in my opinion, they should do the work.

I still wanted to keep an open mind- especially because the Forbes piece said that the American Medical Association was against the restriction - and I tend to trust them. So I looked up the policy of the European Union and Commission. They have an agency similar to the FDA which is called the EMA (EMEA) - or European Medicines Agency. Here is a good synopsis of the similar EMA policy which I am directly quoting from a book chapter comment from a June Raine - " In Europe, subject to certain exemptions explained later, no medicine can be marketed for human use without a Marketing Authorisation granted either by a Member State competent authority or by the European Commission. The regulatory system exists to protect patients by ensuring that marketed medicines meet acceptable standards of safety, quality and efficacy in their indications. Nonetheless, for a range of reasons use of medicines outside their authorised indications, commonly known as offlabel use, and use of unlicensed medicines (i.e. medicines without a marketing authorisation) are common." source here
I wonder what they mean by unlicensed medicines and what the policy is on that? Suffice it to say - if the EU and EC have a similar policy in place, I continue to believe that we are doing the right thing. Bear in mind, the EU is a group of many European countries. You can see the list of countries here and you can review the EMA website here.