There have recently been a spate of warning letters, fines, corporate integrity agreements (CIAs), against pharmaceutical companies and individual actions against people working in the pharmaceutical industry. Several of these penalties have related to illegal promotions and alleged off-label discussions. Nevertheless, because the industries patient's continue to seek health information online, these companies must continue to risk significant penalties to ensure that their patients get the most accurate information possible, via a medium that the patient considers desirable. Resultantly, the industry continues to promote its products online, via various methods including social media, despite what the industry, and the FDA, consider to be inadequate guidance.
This blog is hence the first in a series of related blogs relating to social media and promotion via social media, and what is the likely future of social media in an FDA regulated environment.
Introduction
According to a Harris Interactive Poll: 88% of online Americans look for health information online, with 45.2% of respondents of a burst media poll saying that the internet is their primary source of health information. In light of the significant amounts of incorrect information available online, pharmaceutical companies not only have a duty to help educate their patients, by providing them with the right information, but also have a duty to make this information easy to access and in a medium that these patients expect to find this information.
Pharmaceutical companies realize this necessity and have hence taken steps beyond simply using television or radio advertisements or even posting a static web-page. Many pharmaceutical companies have expressed an interest in engaging their potential patients in a two way discussion. However, in the absence of specific FDA guidance, that discuss how pharmaceutical companies should deal with social media, and in light of the significant warnings, fines and penalties that the FDA and other governmental agencies have imposed, many pharmaceutical companies are hesitant to jump into these perilous, “shark infested waters.”
Pharmaceutical companies realize this necessity and have hence taken steps beyond simply using television or radio advertisements or even posting a static web-page. Many pharmaceutical companies have expressed an interest in engaging their potential patients in a two way discussion. However, in the absence of specific FDA guidance, that discuss how pharmaceutical companies should deal with social media, and in light of the significant warnings, fines and penalties that the FDA and other governmental agencies have imposed, many pharmaceutical companies are hesitant to jump into these perilous, “shark infested waters.”
What is social media?
While individuals in the pharmaceutical companies often agree that “social media” is the "newest, latest and greatest” form of communicating with their patients, few have defined what that term “social media” means. The term “social media” typically brings to mind, the abstract requirement of requiring the use of the internet to communicate. Some would argue that there must be some element of “mobility” associated with the media. Others suggest that there must be a significant portion of interactivity for the medium to be considered “social media”. Others yet argue that social media must have some element of being device neutral and not being necessarily tied to the apple operating system, chrome operating system or windows operating system. Others point to specific platforms, like linkedin, twitter and facebook, and assert that these platforms are “social media” never quite alienating what is not considered to be “social media.” We will be defining Social Media in the abstract: merely as tools and platforms that use the internet as a channel for communication. Such tools not only include linkedin, twitter and facebook, but also include patient communities, blogs, discussion boards, chat room discussions and websites.
Current State of the Art
The United States is part of an exclusive group only two countries that allow Direct to Consumer (DTC) advertising of specific prescription drug products. However, this special treatment carries with it several rules and regulations that must be followed. Specifically, in the event of a DTC promotion discussing a specific drug, a drug company must make significant disclosures in accordance with FDA requirements.
In the alternative, not directly talking about a specific drug, for example by discussing a disease state, affords pharmaceutical companies some flexibility relating to the type and extent of disclosures and risk information that must be shared. These non drug specific advertisements are not ideal since they do not promote an individual product. Nevertheless, they carry certain advantages including (1) a reduction in necessary risk discussions, (2) flexibility of the message communicated and (3) limited liability associated with such an advertisement. Additionally, such promotions allow companies to directly connect and interact with the needs of their patients. Resultantly, several drug companies actively supporting patient communities built around specific disease states, in addition to promotions of specific drugs.
In the next posting, we will be discussing the FDA's position on promotion via the internet.
