The US FDA recently issued an untitled letter to Edenbridge Pharmaceuticals regarding a promotional exhibit for Hemady (dexamethasone) tablets. The agency found that the promotional material misbranded the drug by omitting crucial safety information and making unsupported claims about its benefits. Advertising, according to the FDA’s Guidance for Industry: Consumer-Directed Broadcast Advertising, must remain truthful, balanced, and compliant with regulatory standards.
The FDA’s Office of Prescription Drug Promotion (OPDP) says that the “Hemady Conference Banner” violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) because of:
- Omission of risk information. The exhibit highlighted Hemady’s potential benefits but failed to include any details about its risks. Hemady is known to have serious side effects, including cardiovascular, endocrine, and immunosuppressive complications. Under FDA regulations, promotional materials must provide a fair balance between benefits and risks.
- Misleading efficacy claims. The exhibit suggested that Hemady offered better adherence compared to generic dexamethasone tablets. However, the FDA found that the study supporting this claim was flawed. The research did not adequately control for variables such as patient population differences, disease severity, and treatment regimens. Additionally, the sample sizes were highly imbalanced, with only 43 patients in the Hemady group compared to 3,775 in the generic dexamethasone group, making the results unreliable.
- Failure to provide adequate context. Promotional claims must be supported by strong, well-designed studies. The FDA noted that Edenbridge’s adherence study lacked rigorous methodology, creating a misleading impression that Hemady was superior in real-world use. The agency stressed that failing to disclose study limitations can lead to misbranding.
The importance of regulatory compliance in drug advertising
The case serves as a crucial reminder for pharmaceutical companies about the importance of complying with FDA guidelines when promoting prescription drugs – as well as the meticulous ability of FDA officials to spot violations, errors, and oversights. The FD&C Act and related regulations require drug manufacturers to ensure that their advertising is accurate, i.e. with a fair and balanced view of benefits and risks; supported by reliable evidence so that any comparative claims come with clinical data; and clear and transparent. Companies must ensure that promotional materials provide sufficient context to help healthcare professionals and patients make informed decisions. Noncompliance can lead to serious consequences, including regulatory action, product recalls, fines, and reputational damage.
The FDA has instructed Edenbridge to take immediate corrective action through a cessation of the distribution of misleading promotional materials, a written response within 15 working days detailing how it will correct the violations, and the identification of any other promotional communications that contain similar misleading representations and discontinue them.
For pharmaceutical companies, the message is clear: compliance with regulatory guidelines is not optional. Every claim made in promotional materials must be backed by credible, well-controlled studies, and risk information must always be disclosed alongside efficacy claims. As the FDA continues to monitor promotional practices, drug manufacturers should prioritize compliance, ensure transparency in advertising, and invest in rigorous clinical research to substantiate any promotional claims. Misleading promotions not only risk regulatory penalties but can also erode trust within the healthcare community.
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