Pharmaceutical giant GlaxoSmithKline LLC recently agreed to plead guilty and pay $3 billion to resolve its criminal and civil liabilities stemming from the company’s unlawful promotion of prescription drugs.
Under federal law, it is mandatory for a company to specify each intended use for a drug in its application to the Food and Drug Administration. When the company begins promoting their drug, they are limited to only the intended uses approved by the FDA. Often times, however, these companies look to expand profits by misbranding, promoting unapproved or off-label uses of a drug.
The FDA’s policy that forbids misbranding has been called to question recently on the basis of free speech rights granted to all citizens in the First Amendment. Judge Paul A. Engelmayer of the Federal District Court of Manhattan argues that the First Amendment grants drug companies the right to promote unapproved uses as long as they are truthful claims.
The FDA recently struck down Amarin Pharma, a small drug manufacturer, from promoting off-label use of its cardiovascular health drug Vascepa. Using the free speech argument, Amarin Pharma sued the FDA for threatening to bring civil charges against them if they attempted to sell their drug for off-brand uses.
Those who oppose the FDA’s strict ruling on misbranding argue that the vast therapeutic value of off-brand uses has become the norm for patients as opposed to using drugs for intended and approved uses.
At what point will drug companies have enough? There are a plethora of pharmaceutical monopolies ruling the market and driving up prices simply because they can. With current patent laws these companies have all rights to their drug for years before any other company can attempt to make a generic counterpart at an affordable price.
Fortunately the Supreme Court Case Illinois v. Telemarketing Associates pointed out that the First Amendment “does not shield fraud“”.” Attempts to mislead doctors and agencies about the uses of drugs and medical devices are heavily challenged. In United States v. Harkonen, the conviction of a drug company executive was upheld due to misleading data that was published on the uses of a drug.
Drug companies should not be able to promote what is not approved by the FDA. If they were, why have the FDA in the first place?
I understand that unapproved benefits exist, but it is not the responsibility of the drug company to make me aware of them. The FDA allows doctors to inform patients of the alternative uses of drugs that the company itself was not allowed to promote.
Let’s keep our trust in the people who were specifically trained to treat us.
Drug companies want the additional profit of off-brand benefits yet they refuse to take the responsibility of adverse effects from their drugs. When promoting their drug, these companies inform patients to ask their doctor if the drug is right for them. In this way, they avoid any repercussions by placing all liability onto the doctor.
Free speech is an undeniable right, however, these drug companies are abusing this right in order to turn a larger profit. I wish I believed that these companies were fighting to promote off-brand benefits in order to optimize patient care, but I’m smarter than that, and so is the FDA.
Peter J. Henning, F.D.A’s ‘Off Label’ Drug Policy Leads to Free Speech Fight, NEW YORK TIMES, Aug. 10 2015, http://www.nytimes.com/2015/08/11/business/dealbook/fdas-off-label-drug-policy-leads-to-free-speech-fight.html?_r=0.