This is a guest post by Mark Dimor:
In the December 12, 2012, issue of the NEJM Marcia M. Boumil, J.D. ,LL.M., published an article titled “Off-Label Marketing and the First Amendment”. In it she examined the December 3, 2012, decision of a US appeals court three-judge panel regarding protected speech, the Food and Drug Administration (FDA) regulation of the marketing of prescription pharmaceuticals, and the recent conviction of a sales representative. The salesperson was found guilty by a lower court of engaging in off -label promotion of a prescription drug. The article can be found here, and includes additional information regarding other cases and topics related to free speech and the FDA. Though the responsibility of the FDA is to ensure the safety of pharmaceuticals and the accuracy of the marketing as well as the testing of each new product for the safety and efficacy of its intended use, the FDA authority does not extend to the practice of medicine and “cannot prohibit physicians from prescribing approved drugs for nonapproved uses.”
I want to examine what I see as the key point being made by Boumil: that the court now sees off-label promotion as a free speech issue, and what that may mean as we move forward. The court said, “Government cannot restrict truthful, non-misleading commercial speech promoting the use of a pharmaceutical product, even if off-label.” And the court further stipulated that the government cannot prosecute under the Food, Drug, and Cosmetic Act because the “law at issue discriminates on the basis of the content of the message.” The majority of the panel wrote the following: “If pharmaceutical marketing affects treatment decisions, it does so because doctors find it persuasive,’ and “the fear that speech might persuade provided no lawful basis for quieting it.”
Even the judges see that marketing affects treatment decisions. I will not get into the debate about marketing and its affect on treatments and how it is made persuasive. What we need to consider here is if this ruling stands what do we need to do to defend the potential promotion of “facts” regarding pharmaceuticals within off-label uses.
First, this decision will be heading to the Supreme Court because the FDA cannot afford to spend the time and money monitoring presentations of off-label factual statements about pharmaceuticals. Reviewing every off-label claim for truthfulness is a daunting task that the FDA is not budgeted for nor has the staff. The court may have to decide how the FDA will monitor this free speech and if they can. Or will we wait until there are serious injuries before the FDA can weigh in? Free speech is front and center here and will be in the future but the issue of patient safety remains open and becomes unregulated in this situation. The question in my mind is where does presenting facts used by physicians for off-label indications become an issue of safety? Trusting pharma not to muck the message up with confusing factual data presentations will be challenge for regulators and healthcare professionals (HCP).
Second, we need to believe the pharmaceutical industry will not go whole hog into mass marketing of all drugs for off-label use since there are hundreds of brands that can be used off label. They will pick ones which will yield the greatest revenue. The goal will be to look at this as an opportunity to expand market penetration and use of larger more profitable brands. Smaller marginal brands will not warrant expanded marketing as off-label brands because of low revenue potential. This may moderate the workload of the FDA in monitoring fact vs. fiction.
The use of facts and data may not be balanced and evidence based because there are no comparative trials for off-label use of these brands. It may be comparative in a factual manner but not in the sense of comparative clinical trials and outcomes. Because of the lack of comparative trials of current brands in off-label indications it will be difficult for the HCP to find data to help him monitor and manage off-label use. And current side-effect data in approved indications may not translate to off-label use.
This also plays into the reality of a busy overworked HCP who may not have the time to examine and question off-label facts and data. We know that currently the time it takes and the knowledge needed to perform critical appraisal on information presented by the pharmaceutical industry is extensive and many HCPs have not had the proper training. We can be assured that the information presented for off-label use will not be grossly misleading since the potential for death and lawsuits will be great. However, it may not be scientifically rigorous and balanced, therefore leaving room for a mindful and balanced review.
What the HCP and consumer will face is a new front where more data and information is presented without fair balance in areas new to treatment. Treatment decisions will be made on what the court is calling facts and not comparative data. And we will now have the task of protecting patients and helping HCPs make decisions. It comes down to the cost of educating physicians to understand new data and treatments vs. the money the pharmaceutical industry has to spend in sales. We are out gunned.
Boumil ends her article by asking if striking down governmental regulations in favor of free speech raises concerns about the federal and state regulators ability to impose programs and laws that target specific conduct or an industry. Will this be the beginning of change in a host of laws? I see this as the beginning of a battle on a new front where we as patients and HCPs are ill prepared to fight or defend against.
Mark Dimor has over 25 years experience in healthcare marketing and advertising. In 1993 he opened The BioContinuum Group, moving from marketing and advertising to healthcare education. His goal was to apply strategic concepts from advertising to medical education in order to drive better learning. In 2011, he began work on applying the same adult learning principles to patient learning and eduction and social media. Currently he is producing a film on palliation and hospice care. His goal is to bring better outcomes to all patients through learning.