Top 10 Compliance Tips for Healthcare Communications Companies

Jan. 3, 2019 – As healthcare communicators start off 2019, keeping an eye on the best ways to remain compliant is now a bit easier thanks to James N. Czaban, chair of the FDA and Medical Products Regulatory Practice at DLA Piper LLP in Washington, D.C. Speaking at the Coalition for Healthcare Communication’s Post-election Conference on Healthcare Policy held late last year in Washington, Czaban presented compliance tips that corral best practices into 10 categories, listed below in a  Letterman-style countdown.

10. You’re not selling widgets – act like it. Czaban explained that although drugs and devices have tremendous power to heal and cure, they also have the potential to harm, so companies should never adopt tactics and strategies “to make sales for the sake of sales.” He noted that the legal and regulatory policy elements of the healthcare system are premised on science, rational medical decision-making and economics, that “healthcare product communications should serve as a trusted source of reliable information and advice on all these fronts,” and that data and the fair representation of data are the “order of the day.

9. Don’t throw your clients under the bus. Although the industry is highly competitive and clients demand a lot, “don’t push your clients past the leading edge to the bleeding edge,” Czaban advised, adding that communicators must be conscious of the varying degrees of legal sophistication and internal controls among various clients. “Where a client doesn’t seem to fully ‘get it’ from a compliance or risk perspective, you do them no favor by ‘hitting the gas,’” he said.

8. Don’t let your clients throw themselves (and you) under the bus. Healthcare communicators also must be aware of the varying degrees of risk tolerance and financial motivations among their clients, Czaban stated, and they need to “resist the pressure to be an enabler of willful non-compliance or foolish risk-taking.” At the end of the day, although clients generally are responsible for the legal consequences of their ads, “your reputation is on the line, and you could find yourself in legal jeopardy to boot,” he remarked. For example, he said, the Federal Trade Commission (FTC) may hold advertising agencies liable for a deceptive ad under certain circumstances.

7. Don’t plant any documentary land mines. Because emails and other internal communications “have a nasty habit of showing up in court and in the press,” companies and communicators need to “get a company-wide grip” on how communications – from emails to sales training manuals — are handled, according to Czaban.

6. Remember that FDA is not the only sheriff in town. Although the FDA may be at the top of the list of entities that monitor a company’s actions related to healthcare communications, other agencies, including the FTC, the Department of Justice, and the Securities and Exchange Commission may bring their own actions for false or misleading product claims, Czaban explained. Further, competitors and private parties also can bring cases forward as well, he said.

5. Stay close to the approved-use lane. Even though FDA’s “Consistent with Labeling Guidance” offers some flexibility, there are limits to that, Czaban told the CHC audience, and the agency may still consider information presented to be false or misleading – and subject to enforcement – if the promotional material makes certain claims. Also, FDA’s “Communications with Payors Guidance” addresses healthcare economic information to specific audiences (e.g., not healthcare providers), but not traditional advertising and promotion. Staying close to approved uses in promotional materials also may prevent a False Claims Act prosecution, violations of Corporate Integrity Agreements, and product liability lawsuits, Czaban asserted.

4. ISI is your friend – show it the love. “You and your clients shouldn’t shy away from disclosing in a meaningful, convenient way the important safety information (ISI),” according to Czaban, who stated that the overwhelming majority of FDA enforcement letters are for inadequate or lack of risk disclosures. He said that sales and marketing teams often have an irrational fear of disclosing risk information, and it is surprising “how far they will go to try to slice and dice and obfuscate the information, not just in the sense of leaving it out entirely, but characterizing it in ways that seem plausible” and may involve statistical manipulation to make it sound better. “You, as their colleague and collaborator, shouldn’t be afraid to get into the weeds of some of these discussions, because it can make a difference,” he advised.

3. Focus on the intended audience. FDA’s promotional policies reflect its widely differing views of different audiences such as doctors, patients and payors, so you should be certain that you are aware of which rules apply to doctors and which rules apply to patients. “Don’t fall into the trap of believing that a compliant communication to one audience is compliant if given to another audience,” Czaban said.

2. Show me the substantiation! Czaban told CHC conference attendees that every claim on draft promotional materials should be thoroughly annotated and references should be provided for review. He recommended that review committees have multi-disciplinary membership with relevant expertise as well as independence from marketing functions so they can fairly judge how evidence fits the claims, and that established standard operating procedures should cover adequate timing for review, documentation of deliberations and changes, formal approval sign-off and an appeals process for resolving impasses.

1. When in doubt, seek and heed the advice of counsel.

[Editor’s note: To view Czaban’s full slides from the CHC Post-election Conference on Healthcare Policy presentation, go to:]