The FDA has recently announced that the agency is considering loosening the restrictions on off-label drug promotion in the US. Under the current legislation, physicians can prescribe drugs to treat conditions not included on the approved drug label, a practice which has become common in oncology and pediatrics, but pharma companies are not allowed to actively promote these uses.
However, some at the FDA believe that providing physicians as much information as possible on all the potential uses of a product could improve the standard of care received by patients.
There are many who support this move by the FDA. Those at the Goldwater Institute, for example, argue that drug manufacturers know the most about their products, and it is a major disservice to patients not allowing these companies to use their marketing efforts to communicate what they know with healthcare providers. Phil Lovas, a Republican who sponsored a similar bill to lift restrictions at the state level in Arizona, has echoed these sentiments. Speaking about the Arizona bill Lovas has said, “It just seemed to me that this was a way to give physicians more information to help them treat their patients.”
Furthermore, Peter Pitts, the President of the Center for Medicine in the Public Interest, has argued that it is unreasonable to expect drug companies to conduct clinical trials for already approved products in order to demonstrate their efficacy in treating additional conditions. Not all companies have the ability to spend millions of dollars getting a drug approved to treat condition X, after they have already spent millions getting it approved to treat condition Y. However, according to Pitts, this does not mean that drug companies don’t have a strong insight into how a drug can be used to treat additional conditions.
Despite the arguments made in favor of lifting the restrictions on off-label drug promotion, there are many in the healthcare space who oppose such efforts. According to critics, the number one issue with loosening the restrictions is that it could be damaging to public health. Aaron Kesselheim, from the Program on Regulation, Therapeutics and Law at Harvard Medical School, argues that there have been numerous examples of off-label drug uses being promoted by pharma companies in reckless ways that have led to patient morbidity or mortality.
Then there are those that claim that allowing off-label drug promotion would undermine the whole system of FDA drug approval. As the FDA is an agency with no financial interest in any drug company’s products, it’s approval has been deemed necessary to protect patient health and wellbeing. However, if companies don’t have to prove efficacy to the FDA in order to promote additional uses of their drugs, why would companies ever bother seeking FDA approval for an expanded indication? This could leave companies with free rein to promote whatever drug uses they see fit with no oversight from the external agency charged with protecting patient health.
Critics also point to the fact that, under the current restrictions, there is nothing stopping drug companies from sharing information on off-label drug uses with physicians and other healthcare providers; they just can’t promote off-label drug uses in their marketing.
Given that there are compelling arguments being made on both sides, the FDA will have much to consider before it can make a decision on whether or not to change the current rules.