Does the first amendment protect the marketing of medicine?
Courts, regulators and pharmaceutical companies are engaged in a debate regarding how the first amendment protects corporate speech. For years the FDA has regulated the marketing of medications to doctors. One major provision is that pharmaceutical companies cannot market a drug's off-label uses. Those that promote off-label promotion argue that the ban violates fist amendment rights. Those who endorse the ban believe that it keeps the industry honest and prevents doctors from making decisions which are based on financial incentive or manipulated by commercial interests.
An example of off-label marketing is Pfizer promoting its medication Zoloft to help fight premature ejaculation rather than its primary approved purpose which is to treat depression. With other medications, the implications are more series. Ultimately, as it stands, pharmaceutical companies will pay fines for instances where it is deemed that they violated the ban. Cephalon Inc. was made to pay the government $425 million to settle allegations that its product Actiq was marketed for off-label uses. Actiq is an orally administered narcotic, 80 times more powerful than morphine, that was approved for cancer patients with severe pain. As it turns out, 90% of instances it was prescribed were for other issues such as back pain or migraines.
Pharmaceutical companies will save money and sell more drugs
Despite such infractions, drug companies are hopeful that marketing speech protected by the first amendment will lead to reduced litigation costs. The Supreme Court previously held, in 2011 case Sorrel v. IMS Health Inc., that the first amendment protects a company's right to promote its drugs to prescribers.
Without additional FDA regulations, the Supreme Court will be forced to lift the ban on off-label promotion which will lead to increased prescriptions for unapproved uses. Boston College Professor Stephanie Greene does not agree with the logic behind such moves.
[This is] "market-driven medicine rather than medicine that is based on scientific evidence," said Greene.
The practice of medicine is not public discourse
Professor of Law at Yale University, Robert Post, also had words to say about the first amendment protecting corporate speech. He made the distinction that when a doctor participates in a public forum, that speech is protected by the first amendment. Conversely, when a doctor makes unsound medical decisions, the doctor is then subject to malpractice law. Post put forth the argument that the practice of medicine itself is not a free speech issue.
"Public discourse does not include contracting, product warnings and labels, corporate disclosure forms, or antitrust behavior," writes Post.