FDA Won't Discuss Seroquel Weight Gain Labeling Change

Last week, I noted a press report indicating that the FDA had asked AstraZeneca, makers of Seroquel, to update its labeling to indicate risks of "significant weight gain" experienced by some patients taking the drug. The weight gain issue is important and linked to risks of developing diabetes.

I contacted the FDA and asked for a copy of its letter to AZ and for other information concerning its labeling change request. Here's the answer I got:

"Under federal laws to protect trade secret and commercial confidential information, the FDA is prohibited from publicly discussing or acknowledging labeling change requests until the changes are approved by the agency. (With the exception of class labeling changes where the agency may publicly announce the labeling change request since all drugs in the class are getting the same request.) "The FDA cannot disclose any information about a letter to AstraZeneca mentioned in the news this week. The company would have to disclose information in this case."

I love how federal rules are designed to protect Big Pharma and other businesses but not regular Americans. It's one of the many things I hope President Barack Obama cleans up.