Surprise, Awareness, Adjustment—And Patients First

I remember the day in 1986 like it was yesterday: The public relations community was all abuzz about a regulatory letter issued by the FDA that cited a drug manufacturer’s press materials for promoting one of its products for off-label uses. The letter created shockwaves throughout the drug industry—and the PR world.

The Surprise

Until then, public relations professionals did not fully appreciate that FDA held press materials as being subject to the same regulatory guidelines as paid advertising. The 1986 letter ushered in a new appreciation for regulatory compliance by public relations professionals.

In the early 1990s, FDA issued an advisory letter to the drug industry about video news releases (VNRs) and other public relations materials, advising that “public relations materials that promote drug products and that are issued by or on behalf of those who market the drugs are ‘subject to the requirements of the Food, Drug and Cosmetic Act (FDCA).’” The letter stated that press materials are promotional labeling if they “provide(s) information that makes any representation or suggestion related to the use of an identifiable drug product (whether or not the drug product or its sponsor is explicitly named).”

What is Promotional Labeling?

FDA asserted its authority to regulate press materials by defining them as promotional labeling. The FDA law defines “labeling” as “all labels and other written, printed, or graphic matter: 1) upon any article or any of its containers or wrappers, or 2) accompanying such article at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.” Courts have held that anything that “accompanies” the product is “labeling,” even if it is shipped separately.

Until the 1980s and 1990s, press releases were not a target of oversight and enforcement by the FDA. Wayne Pines, a former FDA associate commissioner and CCC’s current Advisory Board Chair, explains that “drug companies started using press releases for product promotion in the 1980s, as patients started to become more involved in their own healthcare, and the FDA took note and took action when press releases promoted off-label or did not disclose risk.” He adds that the enforcement letters in the 1990s created a “wake up call” to companies.

Between 1996 and 2001, more than 40 enforcement letters were issued citing company press releases for alleged violations of the statute and regulations. The FDA’s attention coincided with the practice of companies that were starting to use websites to post press releases, thus making them more accessible to the public.

Awareness and Adjustment

As a result of increased FDA oversight, PR professionals mobilized to self-educate about FDA enforcement and the implications for the industry. As part of that initiative, I founded the PR section of the Coalition for Healthcare Communication (CHC) in the early 1990s to raise awareness and educate key stakeholders. CHC is an organization that promotes the free exchange of scientific and medical information.

The coalition held several widely attended meetings to discuss how to be compliant in communicating information to the media. Public relations materials have historically been a vehicle for communicating data about clinical data within the context of investor relations (IR) and scientific exchange.

“Scientific Exchange”—Not Prohibited in PR

Communications to stockholders and investors about research activities and pipeline products have not been treated with the same enforcement intensity as promotional materials directed at physicians or patients. The term “scientific exchange” comes from an FDA regulation that’s codified in the Code of Federal Regulations as Section 312.7(a). It says a drug company “shall not represent in a promotional context that an investigational new drug is safe or effective.” But, the regulation goes on to say, “This provision is not intended to restrict the full exchange of scientific information concerning the drug”—including in the lay media.

This means that scientific data on investigational drugs can be included in press releases intended for physicians, patients, and the public. FDA requires that these releases include fair balance, that is, the presentation of balancing risk information. Additionally, companies conducting medical research can also meet with patient groups to update them on scientific developments in regard to both investigational and marketed drugs, as such information may potentially have value for their members. These interactions, typically driven by the PR function, can take the form of educational information packets and in-person meetings. The information itself cannot be false or misleading and must be presented in a balanced way.

“While communications to stockholders and investors about pipeline products has not seen the same oversight by the FDA as communications to physicians and patients, the online environment and openness of company communications makes it critical for any agency in health and science communications to have a thorough and thoughtful understanding of the rules and regulations,” states Donna LaVoie, Chief Executive Officer of LaVoieHealthScience, a firm focused in building value and understanding of health science innovations.

“For any agency involved in solving complex communications for clients, the presentation of balancing risk from both a FDA and SEC perspective is paramount to effectively guiding clients on the right messaging and positioning. It’s this specialized approach that brings value to clients in health and science today.”

Patient Health Comes First

It is clear that regulatory compliance requirements must be “baked” into all communications issued by regulated drug companies. Pharmaceutical marketing must always take into account patient health and promoting a drug for uses that are not approved, or making a product appear safer than it is, could have negative effects on health.

With regulatory compliance top of mind for PR professionals, Michael Rinaldo, Executive Vice President and General Manager, dna Communications, says, “The real question is how our industry is going to adapt to increased scrutiny, be effective, and go forth to help patients and providers.

“Patients are more proactive than ever and there continues to be an interest and need for information,” Rinaldo adds. “We must spend less time wringing our hands and instead focus on responsible communications of drug information. This is particularly important in digital, where we no longer are working with just screens—we’re wearing technology on our bodies. We’ve gone way beyond promotion. It’s about information sharing that’s in the best interest of patients and healthcare providers, as well as the sponsoring company.”

According to Laura Schoen, President, Weber Shandwick’s Global Healthcare practice, an organization committed to regulatory compliance education, including training and testing, “Everyone must feel confident that communications from promotional agencies and their PR industry clients are conceived by individuals who understand the current regulatory environment. In this way, PR programs can be reviewed more efficiently to get in the hands of patients and their healthcare providers more quickly.”

  • Ilyssa Levins

    Ilyssa Levins is President and Founder of Center for Communication Compliance (CCC). Ilyssa helps manufacturers and their promotional agencies save time, money and manage risk, when promoting drugs and devices. She combines her regulatory compliance, marketing communications, and change management expertise to help clients achieve their goals.

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