Food and Drug Administration has scolded the company for a promotional display that claims that the brand is more effective than the general version. This seems to have been cited for the first time by the agency office that monitors advertising.
February 3 letter The prescription drug promotion office posted on the FDA website this week is Edenbridge Pharmaceuticals panel About the treatment of hemady for multiple myeloma at the meeting booth. However, not only lacked important risk information, but the promotion panel insisted that the patient’s compliance with the drug was greater than the generic.
The agency pointed out that research cited by the company did not support this conclusion due to the problem of research design and methodology. For example, it was not clear whether a patient with a general version was newly diagnosed or recurring multiple myeloma, which is a distinct patient group that requires different therapeutic therapies.
This article applies only to STAT+ subscribers.
Unlock this article. Excessive analysis, newsletter, premium event and news notification.
Is there an account already? Log in
Look at all plans