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# OPDP Likely to Target Exhibit Booths: Attorney
- URL: https://www.fdaweb.com/opdp-likely-to-target-exhibit-booths-attorney/
- Published: 2022-02-28T12:00:00.000Z
- Updated: 2026-09-14T17:34:30.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5151251

As FDA begins to transition out of the Covid-19 pandemic, CDER Office of Prescription Drug Promotion (OPDP) staff are likely to resume attending in-person medical conferences and trade shows and will presumably have a renewed interest in reviewing materials disseminated and assessing interactions at the booths in these venues, according to Arnall Golden Gregory partner and food and drug team leader **Alan Minsk**. Speaking about FDA enforcement on his law firm’s 2/23 Webinar, Minsk said OPDP last year signaled its growing interest in medical conference promotions when it announced it would conduct a study on company interactions with physicians at exhibit hall promotional booths.

In a 7/14 *Federal Register* [notice](https://www.govinfo.gov/content/pkg/FR-2021-07-14/pdf/2021-14936.pdf?ref=fdaweb.com), OPDP said it plans to recruit attendees at large medical conferences in the U.S. over one year to participate in the research. It is intended to help OPDP better understand how elements of pharmaceutical booths in exhibit halls affect healthcare professionals’ perceptions of the drugs that are promoted there.

OPDP also said that recent compliance letters have described booth or panel displays that “communicated misleading information regarding drug efficacy and safety, provided insufficient information on drug risks, and omitted ‘material facts’ about the promoted drug. A primary reason that physicians and other medical professionals report visiting specific exhibitors at conferences is to obtain product information, and it is important that the information provided by exhibitors... regarding the risks and efficacy of prescription medications not be false or misleading.”

In his [presentation](https://media.agg.com/wp-content/uploads/2022/02/23162535/FDA-Enforcement-With-Product-Promotion%5F-Year-in-Review-A-Little-Late-and-Issues-to-Consider-in-2022.pdf?ref=fdaweb.com), Minsk identified other subjects of likely enforcement scrutiny by OPDP, such as false or misleading information (e.g., presentation of risk information in a prominent and comparable manner, and misleading comparative claims), promotional activities involving high-risk products (e.g., Covid-19, opioids, biologics, and Boxed Warning products), direct-to-consumer ads (e.g., social media), and more regulatory letters prompted by the agency’s Bad Ad campaign.

Minsk also said 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.” Ironically, Minsk observed, a few days after preparing his presentation, OPDP released a 2/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cytodyn-inc-626957-02112022?ref=fdaweb.com) on a video interview with the then-CEO of CytoDyn, Vancouver, WA, that represented in a promotional context that leronlimab, an investigational new drug, provides a clinical benefit to individuals with Covid-19 ([see earlier story](https://www.fdaweb.com/cytodyn-promoting-unapproved-drug-opdp/)).  
  
OPDP said the drug is misbranded because the video makes conclusory representations in a promotional context regarding the safety and efficacy of leronlimab, which has not been approved or authorized by FDA and whose safety and efficacy have not been established. The company also was told to submit a comprehensive plan to disseminate truthful, non-misleading, and complete corrective communications about the concerns discussed in the letter to audiences that received the promotional video.

Additionally, Minsk’s presentation offered recommendations for companies to help minimize risks in their advertising and promotion activities. They include:

- Testimonials and endorsements must be based on labeled information and must be truthful and not misleading (even if the individual’s personal experience is what it is)
- Limitations of Use statement must be noted prominently, such as part of the indication section in the promotional piece
- If a company uses social media/internet-sponsored links/banner ads, it must still comply with FDA requirements (space or character limitations are not an excuse)
- If FDA provides advisory comments, they should be seriously considered
- Disclaimers help minimize, but don’t eliminate, risk
- Exercise caution with competitive claims because they can be tricky
- Training, training, and training — auditing, auditing, and auditing
- Promotional review committees are a must