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September 25, 2013

FDA: Trends in Enforcement Letters from the Office of Prescription Drug Promotion

During the recent Food and Drug Law Institute's (FDLI) Advertising & Promotion Conference, Julie K Tibbets, a Partner at Alston & Bird, LLP, gave a presentation on Trends in Enforcement Letters from FDA's Office of Prescription Drug Promotion (OPDP). The presentation provided a summary of trends between October 2012 and September 2013 for FDA's drug (CDER) and biologics (CBER) centers.

Providing a broad overview, CDER issued 1 Warning letter and 18 Untitled letters during this period, of which, 2 letters noted that FDA personnel had acquired violative materials at conferences. CBER issued 1 Untitled Letter, and 2 of OPDP's Untitled letters were for biologics.

Tibbets noted that compared to prior years, these numbers show a downward trend, especially in warning letters. The breakdown of FDA concerns/issues for the 19 letters were as follows:

  • Risk information presentations (13)
  • Data from flawed study designs unable to provide substantial evidence for claim (11)
    • Overstatement of efficacy
    • Unsubstantiated superiorirty
  • Investigational product promotion (3)
  • Press/news releases (3)
  • Composite data (1)

Risk Information

After giving this breakdown, Tibbets explained to the audience FDA's legal authorities for regulating the presentation of risk information—namely a product becomes misbranded if its advertising is false or misleading, omits certain required information (e.g., side effects), has an inadequate "brief summary," or lacks fair balance. Tibbets provided the regulations for each of these requirements and an overview of their requirements, including a few examples from FDA's regulator letters.

In addition to these regulations, which are somewhat difficult to navigate, OPDP also uses a 2009 draft guidance on presenting risk information. OPDP's director stated in 2012 that it would update this guidance, however, a July 2013 CDER Guidance Agenda failed to mention any revision or finalization to the 2009 draft. This caused Tibbets to question whether OPDP is currently enforcing the 2009 draft guidance.

Presenting Data From Studies

Tibbets next noted that this area is being more frequently cited in OPDP's letter. She cited FDA's regulations, noting that a drug is misbranded or and advertisement lacks fair balance when it

"Contains a drug comparison that represents/suggests the drug is safer or more effective than another drug when it has not been demonstrated to be safer or more effective by substantial evidence or substantial clinical experience"; or


"Contains a representation or suggestion, not approved or permitted for use in the labeling, that a drug is better, more effective, useful in a broader range of conditions or patients, or is safer than demonstrated by substantial evidence or substantial clinical experience"

In addition, she noted that under FDA regulations, an ad "may" lack fair balance where it

    "Contains favorable information or conclusions from a study that is

inadequate in design, scope, or conduct to furnish significant support for

such information or conclusions"

"Uses statistical analyses and techniques on a retrospective basis to discover and cite findings not soundly supported by the study, or to suggest scientific validity and rigor for data from studies the design or protocol of which are not amenable to formal statistical evaluations"

Consequently, Tibbets then listed a number of study designs, which OPDP cited in its regulatory letters as not being sufficient to amount to substantial evidence for efficacy claims in the promotional or advertising materials. For example, letters cited:

  • Open label studies with no control group;
  • Comparative claims where not all competitors were studied;
  • Meta-analyses based on a literature review;
  • Patient diaries to support adherence claims; and
  • Post hoc analysis in a poster presentation

Investigational Drug Promotion

Next, Tibbets discussed several recent untitled letters regarding the promotion and/or advertising of investigational drugs—that is, products which are not yet FDA approved. She noted that OPDP reviewed materials including company websites, online press releases, web videos, booth brochures and a podcast. Her presentation cited FDA's regulations which prohibit the promotion of an investigational new drug and also provided example's from OPDP's findings.

Press/News Releases

While some in industry still view "print press release" and "video news release" as non-promotional materials, OPDP issued three untitled letters for these kinds of materials during the period Tibbets presented on. She cited the FDA authorities regulating such materials and gave examples from the press releases to show the violations, such as the failure to use the drugs established name and the use of comparative claims.


After her detailed presentation, Tibbets offered several useful recommendations for industry and stakeholders. First, she noted that parties should focus legal and regulatory resources on risk and data presentations:

  • Partner with marketing team members to ensure risk presentations get equal time and attention in promotional materials during drafting stage (including labeling)
  • Lean on medical reviewers to understand study designs/limitations for supporting data
  • Few instances where OPDP issued letters in which risk and data presentations did not warrant mention

In addition, she also told the audience not to overlook investigational product materials and websites and to beware of active verbs implying definitive conclusions. She noted that companies should

  • Ensure product-related press releases undergo multidisciplinary review
    • Ensure legal and regulatory review in particular
    • Same promotional rules and pitfalls apply

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