Question
Your company manufactures an FDA-approved product for spasms in adults, which pediatricians are increasingly prescribing off-label for migraines in children. Your company has substantial evidence
Your company manufactures an FDA-approved product for spasms in adults, which pediatricians are increasingly prescribing off-label for migraines in children. Your company has substantial evidence that, while many children's migraines are effectively treated with your product, children who exceed certain daily dosage levels can develop ulcers. The FDA has declined your request to change the label to include this risk because the product has neither been tested nor approved for use in children or for migraines. Your company believes it has an obligation to pediatricians and their patients to provide information about proper dosing and adverse consequences. Your colleagues have prepared a memorandum recommending speakers' dinners for pediatricians to discuss the proper dosing of your product for migraines, and to explain that ulcers may develop in cases of improper dosing. How would you respond?
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