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The U.S. Food and Drug Administration scolded a Parsippany-based pharmaceutical company for allegedly making misleading claims about its multiple myeloma drug at a conference exhibit booth.

In a Feb. 3 “untitled letter,” the FDA’s Office of Prescription Drug Promotion said Dexcel Pharma USA’s display at the unnamed show only presented efficacy claims for Hemady, but did not include any warnings or precautions for the branded dexamethasone tablets.

The agency went on to describe the omission as “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.”

It also “creates a misleading impression about the benefits of Hemady for the treatment of [MM], an incurable disease whose symptoms most often recur,” the FDA wrote.

Approved by the FDA in October 2019, Hemady can be used in combination with other antimyeloma products for the treatment of adults with multiple myeloma.

Its prescribing information includes warnings and precautions regarding “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.”

Study sticking points

According to the FDA, the most common adverse reactions reported with Hemady are cardiovascular, dermatologic, endocrine, fluid and electrolyte disturbances, gastrointestinal, metabolic, musculoskeletal, neurological/psychiatric, ophthalmic, abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face and weight gain.

The conference display also included a table that suggested Hemady was more effective than generic versions among patients with MM, the agency’s letter says. After reviewing research conducted by Dexcel, the FDA said the findings do not support that conclusion “due to limitations associated with the study design and methodology.”

For example, it was unclear whether patients given a generic version were newly diagnosed or had relapsed multiple myeloma – two groups that are distinct and require different treatment regimes, the agency said.

According to the FDA, another baseline characteristic the study didn’t consider include whether Hemady or generic dexamethasone was used as monotherapy or part of combination treatment. The study also did not factor in the total number of medications a patient is prescribed, number of pharmacies used and patient age to see if there’s an impact on adherence, the FDA said.

Additionally, the study included a “significantly higher number of patients in the generic dexamethasone 4 mg group (n=3,775) compared with the Hemady group (n=43), leading to a notably unbalanced sample size. Such unbalanced sample sizes can lead to overestimation of adherence in favor of the Hemady group,” the agency said.

Problematic advertising

According to the FDA, an untitled letter cites violations that do not meet the threshold of regulatory significance for a warning notice. Unlike a warning, an untitled letter does not include a statement that warns an individual or firm that failure to promptly correct the violation may result in enforcement action.

The agency says it generally posts an untitled letter online when it has received – or anticipates receiving:

• Three or more requests for the document under the Freedom of Information Act;
• Believes doing so would inform the public about practices and conditions that may pose a health risk; or
• Feels doing do would deter future violations.

In Dexcel’s case, the FDA said it received a complaint about the exhibit panel through the agency’s “Bad Ad Program.”

The 15-year-old initiative aims to help health care providers recognize false or misleading prescription drug promotions. Meanwhile it also provides consumers, doctors and competitors a way to report advertising that may not follow guidelines.

The FDA has requested the company reply to the letter within 15 working days. The response should include a list of all Hemady promotional communications with similar representations as well as a detailed plan for discontinuing such materials or ceasing distribution of the drug.

Dexcel did not immediately respond to a request for comment.

As a specialty pharmaceutical company, Dexcel says it focuses on identifying, developing and marketing prescription pharmaceutical products. The 17-year-old drugmaker’s portfolio features a broad range of limited source branded and generic pharmaceutical. Its products aim to “provide high quality, affordable and accessible alternatives in the health care market.”

Up until October 2024, the company was known as Edenbridge Pharmaceuticals. The rebrand occurred two years after Edenbridge became a wholly-owned subsidiary of Dexcel, the largest private pharmaceutical company in Israel.