In an article published by Law360 on June 6, 2022, Alan Minsk and Laura Dona provided an in-depth overview of notices of violation and warning letters issued to pharmaceutical companies over the last 18 months by the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP), as well as a look into the “crystal ball” of what we might anticipate from OPDP going forward.
“In 2021, OPDP issues six letters to drug companies for unlawful promotion: two warning letters and four untitled letters, also known as notices of violation,” Minsk and Dona said. These communications relayed concerns with how various pharmaceutical providers represented risks, efficacy, benefits and efficacy of their products, and in one case, the OPDP expressed concern over the use of a TV ad to promote a drug because it could not adequately provide all the material information needed.
Minsk and Dona also covered three additional letters issued in 2022 by the OPDP. One highlight from those letters for an investigational new drug for preapproval promotion, which is not typical of the OPDP. For another investigational drug, this one for COVID-19 treatment, that FDA public communications previously found not to provide an clinical support for the treatment of COVID-19, OPDP issued a warning letter related to a video claiming strong results and impressive survival rates. The warning letter, as is usual, “required the company to provide a plan of corrective action, using the same media for the same duration of time and with the same frequency that the unlawful messaging occurred.”
Based on the round-up of OPDP letters, Minsk and Dona offered several areas of risk to anticipate and recommendations to address them, included below and available in the PDF download of the article at the bottom of this page:
- Promotional Review Committees are a must for companies seeking to ensure regulatory compliance.
- DTC promotion remains a high area of OPDP scrutiny.
- As the world re-opens and there are more in-person medical conferences and trade shows, we expect FDA to review materials at these venues more carefully.
- OPDP focuses on high-risk drugs, such as those relating to COVID-19, opioids, biologics, and Boxed-Warning products.
- Lack or minimization of risk information, as well as an overstatement of benefit, are on the top of the “don’t do this” list at FDA.
- OPDP carefully reviews the presentation of risk information. We know from a review of enforcement letters and OPDP advisory comments, as well as our experience on clients’ Promotional Review Committees, this issue of risk information presentation comes up constantly. If a company presents the “good” a certain way, it should describe the “bad” in a similar way.
- It is notable that OPDP has used “truthful and “non-misleading” language at times in letters, which is verbiage used by a few courts that have challenged past FDA enforcement letters.
- A company must not forget to include the LOU, if applicable, in the text: omission or truncation can make the promotion misleading. The LOU is part of the indication, and it is insufficient to merely place the LOU in the ISI at the bottom of the page.
- A company is responsible for the statements and actions of its spokespeople. While the statements may be the individual’s personal experience, they cannot run afoul of FDA’s promotional requirements. Paid spokespeople, whether celebrities, patients, or doctors, should be properly trained on FDA’s rules, labeling and promotional requirements. We recommend prepared scripts that PRCs can review in advance. Real-time interviews and other live communications, where it is easy to lose control of the messaging, can be a potential risk area in this regard.
- Social media posts remain a high area of scrutiny because of the difficulty of maintaining fair balance requirements on such platforms. FDA requirements still apply to social media/internet-sponsored links/banner ads.
- Comparative claims are always tricky. A company may attempt to depict its product as better than the competitor with a graph or only a few sentences. It is difficult, however, to tell a full story in a few words. There is a risk that the comparison might be misleading for a number of reasons, including on what the basis the data is derived and shown. In addition, comparative claims may imply off-label uses.
- When evaluating real-world data and its appropriateness for use in promotional materials, companies should ensure all study limitations are considered and be comfortable that the conclusions drawn from the study are scientifically and statistically sound. Qualifiers and disclaimers may minimize risk, but they do not necessarily eliminate the risk.
- A company cannot rely on third-party programs, such as a TV show or a conference, to ensure the promotion is compliant with FDA requirements, particularly if the company intends to use the material for its own purposes.
- Don’t ignore FDA. If OPDP has raised concerns in the past, ask for clarification and consider the comment but don’t disregard.
- Companies must pay attention to links to their websites that could contain violative messaging; if the company wants the benefit of the story, it assumes the regulatory risks. For example, to make another song reference (this time from the band Foghat), a company with an investigational new drug should “slow down, take it easy,” and not promote the product as safe and effective until it receives FDA marketing approval.
- We can expect continued focus from FDA on social science research activities and perception by healthcare professionals and consumers. In addition, Bad Ad complaints will continue to prompt OPDP review.
- FDA might issue a letter on a topic where we haven’t seen recent enforcement (e.g. pre-approval promotion, generic drugs, mobile apps, wellness products) to remind industry it cares about many areas.
OPDP will take action if the song, we mean messaging, hits the wrong regulatory notes. Internal review of promotional pieces, reading past OPDP letters, and monitoring enforcement developments can help companies stay on key.