OPDP’s first enforcement letter of 2025 sent to Dexcel over multiple myeloma drug exhibit
Regulatory News | 04 March 2025 |
FDA's White Oak campus (credit: Ferdous Al-Faruque)
In its first untitled letter of 2025, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) repudiated drugmaker Dexcel Pharma over an exhibit panel for its multiple myeloma (MM) drug Hemady (dexamethasone tablets) that was displayed at a conference.
“This exhibit panel makes false or misleading claims and representations about the risks and benefits of Hemady,” FDA wrote in an untitled letter dated 3 February 2025. “These violations are concerning from a public health perspective because the promotional communication fails to include any risk information for Hemady, a drug with multiple known serious risks, and it creates a misleading impression about the benefits of Hemady for the treatment of [MM], an incurable disease whose symptoms most often recur.”
Specifically, FDA noted that the drug is contraindicated in patients with hypersensitivity to its active ingredient and any of its excipients, as well as in patients with systemic fungal infections. Other warnings and precautions include potential “alterations in endocrine function, immunosuppression and increased risk of infection, alterations in cardiovascular/renal function, venous and arterial thromboembolism, vaccination, ophthalmic effects, gastrointestinal perforation, osteoporosis, myopathy, behavioral and mood disturbances, Kaposi’s sarcoma, use in combination with anti-myeloma products, and embryo-fetal toxicity.”
FDA said it also received a complaint about the exhibit via its Bad Ad Program.
FDA explains in the letter that Dexcel failed to include any risk information in the exhibit and instead focuses solely on benefits, including that the drug can reduce the number of tablets a patient needs to take due to its unique strength compared to other dexamethasone tablets.
The panel also included a table that presents what the company purports to be real-world adherence data comparing Hemady to generic dexamethasone products in patients with MM that suggests better patient adherence to Hemady.
“However, the referenced study does not support conclusions regarding comparative adherence to Hemady and generic dexamethasone 4 mg in the treatment of patients with MM due to limitations associated with the study design and methodology,” FDA wrote, noting that, “In contrast with patients in the generic dexamethasone 4 mg group, the study did not take measures, such as the use of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10 CM) codes, to determine whether patients in the Hemady group were in fact diagnosed with MM.” Additionally, the patients in the generic group were diagnosed using ICD-10 CM codes for patients with newly diagnosed MM and relapsed or refractory MM.
Other issues with the study included an imbalance in the populations of the two groups, 43 patients in the Hemady group compared to 3,775 in the generic dexamethasone arm, and the fact that it did not account for whether either treatment was used as monotherapy or as part of a combination treatment.
FDA requested that the company submit a response to the letter within 15 working days listing all promotional communications for the drug with similar representations and to detail its plan for discontinuing such communications or ceasing distribution of the product.
Untitled letter
“This exhibit panel makes false or misleading claims and representations about the risks and benefits of Hemady,” FDA wrote in an untitled letter dated 3 February 2025. “These violations are concerning from a public health perspective because the promotional communication fails to include any risk information for Hemady, a drug with multiple known serious risks, and it creates a misleading impression about the benefits of Hemady for the treatment of [MM], an incurable disease whose symptoms most often recur.”
Specifically, FDA noted that the drug is contraindicated in patients with hypersensitivity to its active ingredient and any of its excipients, as well as in patients with systemic fungal infections. Other warnings and precautions include potential “alterations in endocrine function, immunosuppression and increased risk of infection, alterations in cardiovascular/renal function, venous and arterial thromboembolism, vaccination, ophthalmic effects, gastrointestinal perforation, osteoporosis, myopathy, behavioral and mood disturbances, Kaposi’s sarcoma, use in combination with anti-myeloma products, and embryo-fetal toxicity.”
FDA said it also received a complaint about the exhibit via its Bad Ad Program.
FDA explains in the letter that Dexcel failed to include any risk information in the exhibit and instead focuses solely on benefits, including that the drug can reduce the number of tablets a patient needs to take due to its unique strength compared to other dexamethasone tablets.
The panel also included a table that presents what the company purports to be real-world adherence data comparing Hemady to generic dexamethasone products in patients with MM that suggests better patient adherence to Hemady.
“However, the referenced study does not support conclusions regarding comparative adherence to Hemady and generic dexamethasone 4 mg in the treatment of patients with MM due to limitations associated with the study design and methodology,” FDA wrote, noting that, “In contrast with patients in the generic dexamethasone 4 mg group, the study did not take measures, such as the use of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10 CM) codes, to determine whether patients in the Hemady group were in fact diagnosed with MM.” Additionally, the patients in the generic group were diagnosed using ICD-10 CM codes for patients with newly diagnosed MM and relapsed or refractory MM.
Other issues with the study included an imbalance in the populations of the two groups, 43 patients in the Hemady group compared to 3,775 in the generic dexamethasone arm, and the fact that it did not account for whether either treatment was used as monotherapy or as part of a combination treatment.
FDA requested that the company submit a response to the letter within 15 working days listing all promotional communications for the drug with similar representations and to detail its plan for discontinuing such communications or ceasing distribution of the product.
Untitled letter
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