FDA warning letter: DAVA sample request letter contains no risk information
Pharma Compliance Alert, September 27, 2006
A sample request letter from DAVA Pharmaceuticals fails to include any risk information for the drug in question, VoSpire ER Extended-Release Tablets, according to an FDA warning letter. According to the FDA, this complete omission of risks raises public health and safety concerns by suggesting the drug is safer than has been demonstrated.
The sample request letter also overstates the drug's efficacy by including the claim that twice-daily dosing improves compliance, according to the warning letter. The FDA says that although the dosing may be more convenient than products taken 4-6 times per day, the FDA is "not aware of any evidence supporting enhanced compliance rates," and no references were cited to support the claim.
The FDA requests that DAVA immediately cease distributing the sample request letter and submit a written response that includes information about the company's plan to disseminate truthful, corrective messages.
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