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RWC716 Regulatory Writing & Communications
Task:
Omission of Material Facts
Promotional materials are misleading if they fail to reveal material facts in light of representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The Dosing and Straightforward IV Administration – Infusion Examples webpages of the Busulfex website present information regarding dosage and administration for pediatric patients, but omit important material information regarding the risks associated with the use of Busulfex in this patient population. Specifically, these presentations omit the risk of cardiac tamponade observed in pediatric patients receiving high doses of oral busulfan.
The webpages also fail to include the adverse events reported for pediatric patients including vomiting, nausea, stomatitis, GVHD, HVOD, and pneumonia. By failing to communicate this important risk information, the website misleadingly suggests that Busulfex is safer than has been demonstrated by substantial evidence or substantial clinical experience.
The Important Safety Information section on the bottom of each webpage and the Clinical Trial Results – Safety Profile webpage present some information regarding the risk of HVOD, but omit material facts regarding HVOD and hepatotoxicity. In particular, the WARNINGS – Hepatic section of the PI states, “Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or a prior progenitor cell transplant may be at an increased risk of developing HVOD with the recommended BUSULFEX dose and regimen.”
Moreover, the PRECAUTIONS section of the PI states, “To Reference ID: 3029738 Ms. Stephanie H. Jameison, MBA, RAC Page 3 Otsuka Pharmaceutical Development and Commercialization, Inc. NDA# 020954 / MA# 77 detect hepatotoxicity, which may herald the onset of hepatic veno occlusive disease, serum transaminases, alkaline phosphatase, and bilirubin should be evaluated daily through BMT Day.” Finally, the ADVERSE REACTIONS – Hepatic section of the PI indicates that hyperbilirubinemia occurred in 49% of patients, was grade 3/4 in 30% of patients, and was considered life-threatening in 5% of these patients. Hyperbilirubinemia was associated with both GVHD and HVOD. By omitting these material facts, the website suggests that Busulfex is safer than has been demonstrated by substantial evidence or substantial clinical experience.
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