In January, the FDA released its long-anticipated draft guidance, regarding promotion of a medication’s benefits that are not part of the Prescribing Information—known as “off-label communications.” It’s clear the FDA’s priority is ensuring industry communications remain consistent with approved labeling, and that limitations of the strength of evidence are accurately characterized. In short, the guidance is a constant reminder for communicators that transparency and disclosure are paramount for the ethical and compliant engagement of stakeholders by industry.
For years, policymakers, advocates, and other industry watchdogs, all laser-focused on ensuring transparency, have intensely—and appropriately—scrutinized the pharma industry. As communicators, we’ve seen how a lack of transparency can have dire consequences on a company’s reputation, often forcing a change in narrative from the desired one of “serving public health” to the perceived one of “focus on profit.”
Impact of a Lack of Transparency
Further, the impact of a lack of transparency has been widely felt. Communication professionals can empathize with those who supported brands such as Vioxx, Avandia, or Vytorin—each of which became mired in controversy related to information disclosure. In recent years, the pharma industry has increased its transparency efforts. Initiatives such as the PhRMA “Principles for Responsible Clinical Trial Data Sharing,” Bioethics Internationals’ “Good Pharma Scorecard,” and the data transparency policies adopted by several companies are all contributing to improving the industry’s reputation and winning public trust.
It is incumbent upon us, as communicators, to advocate for transparency with our clients. As evidenced by the FDA’s draft guidance, there will always be scrutiny regarding how companies disclose info. There should be, and we should welcome it. Although these could lead to difficult conversations, reminding our clients that all adverse events need to be communicated in press materials, or that physician compensation needs to be disclosed, it is critical to ensure communication strategists and counselors continue to bring value by taking on the responsibility of maintaining compliance, and ensuring that faith in the pharma industry remains strong.
The good news? Our clients are resolute in these efforts, and that is beneficial for all of us—agency counselors, our clients, and the public-at-large.
Key Learnings for Communication Strategists:
- Preserve public trust: Maintaining faith in the pharma industry is paramount, and we are the first-line defenders of transparency.
- Emphasize disclosure: Agency counselors in particular have an important responsibility to clients to ensure appropriate information sharing, in order to elevate the industry narrative of serving the needs of public health.
- Understand regulatory guidelines: Communication professionals who are savvy in FDA guidance can counsel clients around safety data and other important disclosures.
- Keep transparency top-of-mind: Remember lessons learned. External scrutiny of the pharma industry is pervasive, but through transparency, we can demonstrate commitment to patients and solidify trust.