The summer season hasn’t slowed down the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) from taking enforcement actions against perceived unlawful product promotion. A review of these enforcement letters, without identifying any particular company or product, offers insight into some of OPDP’s concerns, which companies should consider as they promote their products. We will not review each enforcement letter or every type of violation in detail. Instead, we emphasize the key trends that these letters reveal, and also discuss other relevant non-OPDP related enforcement.
Summary of OPDP Enforcement
The most frequent violations cited by OPDP continue to focus on minimization and omission of risk information and material facts, misleading comparative claims, unsubstantiated claims, and overstatement of efficacy claims. In addition, whether the promotional materials are distributed online or by physical means, OPDP will take enforcement action if it has objections.
Minimization and Omission of Risk Information
The agency continues to find problematic the presentation of risk information that is not comparable to benefit claims. Examples included: a print ad that discussed drug benefits in large, bolded or colorful text with graphics, while presenting risk information on the adjacent page without a color scheme, borders, or graphics; OPDP stated the risk information “appears unconnected to the efficacy claims and is therefore not likely to draw readers’ attention;”
- a sales aid that discussed the most important risks on its back cover in black font in single-spaced bullets, while the effectiveness claims appeared in large, bolded headlines with colorful graphics; and
- a website that presented drug benefits at the top of the page accompanied by colorful graphics and large bolded headers, but discussed risks at the bottom of the site under the product logo, a tagline, footnotes, and citations; OPDP expressed concern that viewers might
- think information beneath this content was not important or related to the main message.
In other enforcement letters, FDA objected to promotional materials that included the name and indication but failed to disclose any risk information, such as:
- two online banners that discussed the drug’s indication and efficacy claims, e.g., “Twice as Strong Half as Long;”
- a print ad that included the company logo, drug name, indication, and a question with the disease identified (and which also was not submitted to OPDP on a Form 2253 at the time of initial distribution); and
- a promotional email sent to healthcare professionals implying the product’s safety and efficacy, (e.g., “Eliminate Your Concerns” (emphasis in original) and “Remove the Variables” (emphasis in original) with the word ”Dosing” near the claim) without including the drug’s full approved indication or information that administration of the drug required additional steps related to reconstitution.
Omission of Material Facts and Risks Listed in the Prescribing Information
In several instances, OPDP used a product’s prescribing information to identify missing information from the promotional material. For instance, OPDP cited violations when:
- a sales aid’s headers stated “hematological side effects . . . can be predicable and manageable,” (emphasis in original) even though the [product labeling] disclosed that the most common adverse reactions of the drugs were “[c]ytopenias with delayed onset and prolonged duration, some complicated by hemorrhage and severe infection;”
- a sale’s aid claim that patients taking the drug experienced a certain median time to progression compared to other patients, but omitted stating that this information was “not significantly different between study arms,” as the product labeling noted;
- a sales aid’s imagery and claims suggested that a drug can target lymphoma cells without targeting health cells, (e.g., the drug can deliver “radiation precisely where it’s needed” (emphasis in original)), but the [product labeling] stated that the drug can cause damage in both target and nearby cells;
- a print ad’s claim that a drug did not require “dosage adjustments,” (emphasis in original) but the product labeling mentioned that dosage should be reduced for certain patients with renal impairment; and
- a webpage contained graphics and claims about a drug’s mechanism of action (e.g., raising “the levels of all three of the neurotransmitters in the brain responsible for mood elevation . . .”), despite the product labeling disclosing that the drug’s mechanism by which its “inhibitors act as antidepressants is not fully understood.” (emphasis in original).
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