Independent Study: Rules and Regulations—The FDA’s Role in Pharma Communications and Marketing


You probably thought after hearing Beyonce’s hit song, “Girls Run the World,” that you had a pretty good idea of who was in charge. But, I’m here to tell you that you’re wrong– at least in the world of pharmaceutical communications. The prescribing information, approved by the FDA, on package inserts actually runs the world. Or at least dictates what can and cannot be communicated about a drug.

Salter and colleagues argue in Pharmaceutical Industry Medical Communications Departments: Regulatory and Legal Perils and Pitfalls that although the prescribing information is meant to be the “primary document that contains all of what should be needed for the safe and effective use of the pharmaceutical product,” it often fails to meet all of the communications needs. So, what’s a pharmaceutical communicator to do? Especially when a healthcare provider inquires about a drug and its use? Tread lightly and follow a few rules.

The authors advise to adopt and follow established policies and procedures, maintain compliance, seek advice from peers, senior staff, and experts, seek input form customers, don’t practice medicine or provide formal consultations, document everything, watch out for copyright infringement, and have an internal document review.

Are you tired just from reading that list of recommendations? Me, too.

Image: FDA/Flickr

I find it fascinating that the little packet of paper you usually toss out upon receiving a prescription is the one piece of information meant to be the bible regarding the drug, but as Salter and colleagues point out, this very piece of paper has been deemed pretty lousy by the American Medical Association. And Salter’s citations give numerous examples of when this insert has been deemed ineffective for the job at hand.

Making things even more complicated, as introduced by David G. Adams in FDA Regulation of Communications on Pharmaceutical Products, is that the FDA has a broad stroke in terms of regulations. Not only do they regulate the copy on the drug insert, in 1950, they moved to extend their jurisdiction. “The agency asserted that labeling must bear a description of all intended uses, including those communicated outside of labeling.” So, now the FDA not only oversees the insert, they oversee the content of your newspaper ad, your pitch to a healthcare journalist, the content in your educational session for doctors, and your nicely-designed infographic.

Adams covers a number of cases where the FDA has successfully staked its claims over virtually everything and every way a company might communicate about its drug. And, he lays out a 1962 decision where Congress gave the FDA even more power via the Federal Food, Drug and Cosmetics Act. “Under the interpretation of the FDC Act, the definitions of labeling and advertisements are distinguishable only by the form of the communication. Generally speaking, if the communication is in written, printed, or graphic form, it is subject to regulation as labeling; otherwise it is subject to regulation as an advertisement.”

Most experts agree that although the act technically covers just written communications—they advise that all communications adhere to the rules and regulations.

When considering new media’s role in pharmaceutical marketing, it’s easy to see how companies have been notoriously cautious to enter the field. Communications must be tightly controlled, and embarking on something like a Twitter chat could be treacherous ground— multiple stakeholders, no script, and an inability to completely shape or control the message to ensure adherence to the package insert or previously-approved messaging.

Adams argues, “the agency’s interpretation of its jurisdiction over labeling and advertisements provides a seamless regime for regulating the substance of almost all prescription drug information emanating from a vendor.”

While patient safety is at the heart of the FDA regulations, one of the questions I’ve woven into my expert interviews during this quarter is about how creativity and innovation are impacted by rules and regulations. My hunch is that it does impact the creative process and can limit new media involvement for communicators as they learn about new platforms and tools and how these tools might integrate into their current work and adhere to regulatory requirements.

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