We all know the story of David versus Goliath. But this is the story of David versus Godzilla. Godzilla is the King of Monsters. Godzilla is bigger, meaner and more destructive than Goliath. In this story Godzilla is the FDA, perhaps, the King of Unchecked Powers of Oppression. In the name of science and protection of patients they’ve used their rather unlimited powers to restrict pharmaceutical companies from making true and well-founded statements about their products to health care professionals thereby impeding innovation and, more importantly, physicians’ ability to make informed, intelligent decisions that could lead to better patient care.
In this story David is not one of those super-sized, multi-billion dollar revenue pharmaceutical companies but a small company, Amarin Pharmaceuticals, Inc. As the story goes Amarin challenged the FDA regarding their right to engage in legitimate off-label marketing. Off-label use is when health care professionals treat patients for diseases with pharmaceuticals and/or in doses that the FDA has not reviewed. Physicians engage in off-label practices as a way to advance treatment for patients, particularly in disease areas such as fighting cancer and managing psychiatric disorders. For example, physicians might use a treatment approved by the FDA for “adults” off-label in pediatric care. It’s legal for physicians to engage in off-label practices. In fact it is rather prevalent with an estimated one of five prescriptions going for non FDA- sanctioned uses in the U.S.
However, the FDA prohibits pharmaceutical companies from making off-label claims even where they are backed by evidence. If a pharmaceutical company or one of its sales representatives advances a well-founded, but non FDA-reviewed, off-label claim they will face aggressive prosecution. They can expect sizable fines (like in the billions) and, perhaps, jail time as the FDA considers off-label claims as crimes.
It wasn’t a stone that dropped the FDA. It was the court. Namely Judge Paul Engelmayer upheld the Second Circuit Court of Appeals 2012 decision in the U.S v. Caronia case that truthful promotion of off-label use is protected by the First Amendment, which the FDA cannot regulate. In the aforementioned case it was determined that barriers to the truthful promotion of off-label use “could inhibit, to the public’s detriment, informed and intelligent treatment decisions.” In other words it could interfere with patients getting treatments they need and deserve.
Now this story of David versus Godzilla isn’t about lowering standards for sound research or waving the flag regarding First Amendment rights. Instead, it’s about a small company taking on a behemoth, at considerable risk to itself. Big pharmaceuticals companies with far greater resources could have taken on and beaten the FDA on this and other abuses prohibiting truthful promotion. (For example, sales reps cannot compare two independent studies of different compounds against the same standard of care for a given condition because the two compounds under study did not conduct a head-to-head. In other words if compound Y achieves a 90% cure rate versus standard of care and compound Z only achieves a 60% cure rate against the very same standard of care then the sales reps of compound Y cannot share this information with physicians. If you had the condition under study would you want to know this information? All other things being equal, such as safety and tolerability, which compound would you want to be treated with?)
The truth of the matter is that big pharmaceutical companies are afraid of retaliation from the FDA of not gaining approval for one of their drugs, or having the approval process drag on, or being saddled with overly-restrictive labeling, or having their claims restricted, or undergoing intense FDA scrutiny of every move they make. Only one came forth from the multitudes, a small pharmaceutical company whose existence was threatened by the FDA’s restrictive practices.
If something is wrong, whether it be with proposed marketing, communications and/or organization dysfunction, it is up to us to blow the horn. As Jon Stewart says in his final appearance as host of the Daily Show, “The best defense against b*ll sh&t is vigilance. So if you smell something, say something.” Blow the horn!
