FDA Policy/General

OPDP Hits Edenbridge Pharma Over Promos

CDER's Office of Prescription Drug Promotion (OPDP) has cited Edenbridge Pharmaceuticals over promotional materials used at a medical meeting exhibit booth because they made “false or misleading claims and representations about the risks and benefits of Hemady,” according to a just-posted untitled letter. “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 multiple myeloma (MM), an incurable .disease whose symptoms most often recur,” the letter says.

OPDP took particular issue with the firm’s exhibit panel that presented efficacy claims for Hemady but failed to communicate any risk information. For example, the exhibit panel claimed the following:

“Hemady reduces up to 80% of the number of tablets required for a therapeutic dose of dexamethasone for the treatment of adults with MM”
“Hemady is a unique strength dexamethasone tablet bioequivalent to five 4 mg tablets of dexamethasone”

However, the agency says that by entirely omitting all risk information, the exhibit “fails to provide material information about the consequences that may result from the use of Hemady and creates a misleading impression about the drug’s safety.”

Additionally, the letter cites the exhibit panel’s reference to “real-world comparison of adherence to Hemady and generic dexamethasone among patients with MM” which suggested improved patient adherence to Hemady as compared with generic dexamethasone 4 mg tablets. “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,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome