Wednesday, August 12, 2009

ALERT - FDA Rejects Astellas attempt to protect transplant patients

Astellas Pharmaceuticals announced on August 10 that the FDA has rejected their Citizen Petition asking for additional regulation on generic substitutes for immunosuppressants. The petition was filed because of concerns that generics are NOT equivalent to brand name drugs. The FDA's decision is a HUGE setback to the safety of transplant patients. Included in the Citizen Petition was a request for labeling changes on immunosuppressant drugs. The changes would have included a requirement that the patient's transplant physician be notified ANYTIME the patient's immunosuppressants are changed. You may remember that back in the spring I was involved in legislation before the Tennessee legislature that would have required this same notification. Unfortunately, that bill failed. The large pharmacists lobby was largely responsible for that. I suspect they played a big role in the FDA's decision, too. Furthermore, Astellas is considering taking legal action against the FDA in U.S. District Court. You can read the complete press release from the Astellas website by clicking the following link :

Tonight, I'm gonna do something I have not done before on this blog. I'm gonna make a prayer request. Please pray that Astellas' court action be successful. Transplant patients need this. Physician notification when immunosuppressants are changed is VITAL to our safety. It has the potential to be the difference between life and death.
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