A Year in Review: FDA Enforcement in the Prescription Drug Advertising and Promotion World

Good riddance to 2020 for so many reasons. But, as the AGG Year in Review of the Food and Drug Administration’s enforcement of prescription drug advertising and promotion has become an annual ritual, let’s take a quick peek back and review some themes and trends.

What Did We See in 2020?

• FDA’s Office of Prescription Drug Promotion (OPDP) issued six letters to companies for unlawful promotion – four Warning Letters and two Untitled Letters. In comparison, in 2019, OPDP issued ten letters – three Warning Letters and seven Untitled Letters.

• OPDP continues to focus on promotional materials that lack any risk information. Often, the materials provided links or signals to signify where to find safety information, but the agency said this was inadequate. The bottom line is that if a company provides the “good” (e.g., the indication, a claim of benefit), it must provide some “bad” (e.g., risk information) at the same time.

• High-risk products, such as those containing Black Box Warnings, remain most likely to receive Warning Letters if there are promotional violations.

• The “Bad Ad” Program, where doctors are encouraged to notify OPDP of violative promotion, continues to remain a source by which FDA obtains information. A number of letters specifically noted that the complaints came to OPDP’s attention through the Bad Ad Program.

• Many companies think that OPDP only regulates new drug application (e.g, innovator) products. Any application drug product, including abbreviated new drug applications, must comply with FDA’s labeling requirements. OPDP reminded two abbreviated new drug application (ANDA) companies in 2020.

• Time doesn’t heal all wounds, OPDP reminded industry. In one case, a TV advertisement to which OPDP objected, was no longer running, but that was irrelevant; the damage was done. In addition, where OPDP required corrective action, the company was required to use the same media or forum to fix the original violative messaging.

• Keep in mind that “prior communications” with OPDP, the FDA review division, or both, will be cited in enforcement letters, including correspondence to prior sponsors for similar violations. If the previous sentence looks familiar, it should. We wrote it in our 2019 year in review, but it applies here as well. In 2020, OPDP issued a Warning Letter to a company, where it noted it had sent advisory comments about the product and was concerned that the advertisement did not adequately convey the FDA-approved indication or important risk information. Companies should always review and consider advisory comments from OPDP and, if acquiring another company’s product, obtain the communications history with OPDP (and the review division). In a separate letter, OPDP noted it had expressed concerns to the previous application holder and referred to continued unlawful promotion.

• Do not forget to include the product’s Limitation of Use if the product has one in the indication. It is part of the indication; it is not a mere fun fact. Furthermore, do not truncate the indication.

What We Saw From Industry

• 2020 was a transformative year for pharmaceutical marketing initiatives. Conferences turned virtual, and so did pharmaceutical booths. FDA did not issue guidance specific to virtual booths and conferences. Until the agency does issue guidance (if it does), existing FDA guidance applies. The same requirements (e.g., fair balance, truthful and not misleading, providing the prescribing information) still apply, even if the virtual booth is a space-limited platform.

• We saw an increased interest in marketing on social media platforms (a trend we have been seeing for the past several years). Our advice (and FDA’s guidance) on social media marketing has not changed. The basic rules of complying with product labeling and advertising apply. To quote Led Zeppelin, “the song remains the same.”

• In addition, we noted an increased reliance on email communications (due to lack of face-to-face interactions with physicians and others). Remember, emails (and their subject lines) can be “labeling” and must comply with FDA’s promotional requirements.

• Not surprisingly, there were a number of marketing materials related to the treatment of COVID-19. Remember, the pandemic has not affected FDA’s long-standing position regarding off-label promotion. Products should not be promoted as treating, mitigating the risk of, or diagnosing COVID-19 without authorization or approval from FDA to do so.

What Might We See in 2021?

• As many know, OPDP’s long-serving Director, Tom Abrams, retired. We do not expect to see much change in policy or enforcement trends.

• We believe that OPDP will continue to focus its enforcement energies going after false and misleading promotions, rather than off-label (e.g., unapproved) use promotion. However, the agency has made very clear in past statements that it will take action and, notwithstanding the court cases where it has lost (and which we have documented), we think that, if OPDP finds an unlawful promotion with “good facts” of clear violation and public harm risks, it might test the legal waters again. Even if it doesn’t, we caution clients to consider other risks, such as product liability exposure, Department of Justice or state prosecution, or competitor challenges (to name a few).

• There are some rumblings that OPDP might issue some guidance related to social media promotion. However, the timing, scope and subject matter are uncertain.

• Based on 2020 deficiencies noted in Untitled Letters and Warning Letters, we believe OPDP will continue reviewing more closely the presentation of risk information, such as prominence and placement. While there may be an element of subjectivity about “how much” and “exactly where” to place risk information, it is clear that OPDP thinks that many promotions are not properly balanced. While in some pieces the risk information might have been present, OPDP challenged that the placement was so small when placed in comparison or conspicuousness to the larger positive messaging, or was difficult to find, that the overall promotion was “misleading.” Similarly, OPDP has challenged some companies’ failure to include all relevant safety information from the Prescribing Information or, alternatively, making “Easy to Use” claims when the product required multiple steps to use may be misleading. Therefore, companies should carefully review the PI, advisory comments (if any), and the whole message to ensure the complete picture is accurate, clear, and balanced.

• While not specific to FDA, we have already seen some companies review their policies concerning speaker programs, in light of the Office of the Inspector General’s Special Alert on the topic. The Special Alert reinforced that companies should not use such programs to pay doctors unnecessarily to speak to curry favor and prescribe or refer prescriptions and have doctors hear the same promotional messages and pay for their meals, i.e., be careful of anti-kickback violations. We prepared a Bulletin on the Special Alert available here. We might see the OIG issue more Special Alerts in 2021 affecting the industry. Of course, we will issue Bulletins, as appropriate.