Adriane Fugh-Berman of PharmedOut Tells FDA that Off-label Promotion Undermines Public Health | Pharma Industry Regulation |

Several speakers [at FDA’s recent hearing on off-label promotion (see] weighed in on whether or not, and if so, how, the First Amendment applies to marketing of "off-label" medications. Many speakers said that communications between pharmaceutical companies and healthcare providers should not be restricted as long as they are not misleading (read “What is ‘Truthful and Non-misleading?’ That is the Question FDA Must Answer to Allow Off-Label Communications by Pharma”; Most agreed that direct-to-consumer marketing of off-label uses is riskier.


But determining whether or not such communications are misleading is not as easy as it may sound, because such marketing might be based on research that is published in a medical journal but does not meet the FDA's rigorous standards. Some less-rigorous studies are ghostwritten, reprinted, and widely disseminated. In addition, communication about off-label use of medications and devices often occurs one-on-one with healthcare providers "behind closed doors," as opposed to at a medical conference where industry claims can be more easily challenged.


Most agreed about the need for physicians and patients to have access to the most current data about the safety and efficacy of new treatments. Insurance companies also need to have the most current economic information about disease burden and overall cost to make coverage decisions.


"Off-label promotion undermines public health; industry education is always misleading; and trust in Pharma goes against the evidence," said Adriane Fugh-Berman, MD, a physician and associate professor at Georgetown University Medical Center, Washington, DC. Dr Fugh-Berman is also a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical marketing practices ( 


Between 73% and 81% of off-label prescriptions are for conditions for which there is little or no scientific support for efficacy, she said. "We know that promotion increases prescriptions; if the FDA loosens restrictions on off-label promotion, irrational prescriptions and associated harms can be expected to skyrocket," she explained.


Dr Fugh-Berman acknowledged that there are legitimate off-label uses for some medications, but she also said that off-label use increases adverse effects, which are even higher when drugs are used in ways that lack scientific support.


Several speakers said they would be submitting additional information between now and January 9, 2017. The public is invited to submit electronic or written comments to or the Division of Dockets Management (9HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. All comments must be identified with docket number FDA-2016-N-1149.

Additional information related to this public meeting can be found on the FDA website.