The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.
The letter, released to the public last week, explains that the representative’s statements – made during a single lunchtime presentation to health care professionals – misbranded the medicine in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).
The representative allegedly “minimized serious, life-threatening, risks associated with Fycompa,” and “downplayed” the risks of “homicidal ideations and aggressive behaviors” by suggesting health care practitioners should “not worry” about them, according to the partially redacted letter. When attendees asked questions about the warnings, the representative “further downplayed the medication’s warnings with anecdotal claims regarding the age of pediatric patients who experienced serious psychiatric and behavioral reactions,” and claimed that epilepsy centers that carry the product on formulary “were not concerned about the Boxed Warning.”
The letter describes the alleged off-label promotion as “especially concerning from a public health perspective,” because the representative reportedly claimed the medication was “intended for new uses for which it lacks approval, and for which the labeling does not provide adequate directions for use.”
The OPDP sent this letter in response to a complaint submitted through the FDA’s “Bad Ad Program,” which is “an outreach program designed to educate health care providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.”
The OPDP has provided the following guidelines –
Prescription drug advertising must:
- Be accurate
- Balance the risk and benefit information
- Be consistent with the prescribing information approved by the FDA
- Only include information that is supported by strong evidence
What types of promotion does OPDP regulate?
- TV and radio advertisements
- All written or printed prescription drug promotional materials
- Speaker program presentations
- Sales representative presentations
OPDP does not regulate promotion of:
- Over-the-counter drugs
- Dietary supplements
- Medical devices
- Omitting or downplaying of risk
- Overstating the effectiveness
- Misleading drug comparisons
The FDA has requested that the company (a) immediately cease violating the FD&C Act, (b) respond by October 25, 2018, identifying all promotional materials containing the violations mentioned in the letter, and (c) explain its plan to discontinue using such materials.