August 11th, 2009
Astellas Pharma US Inc. has publicized the US Food and Drug’s rejection of the company’s Citizen Petition to secure the safe and valuable use of immunosuppressants. The anti-rejection medication is used to avert organ transplant rejection. Astellas appealed to the FDA in their petition to conduct further measures to protect transplant recipients. Astella firmly believes that this group of patients (transplant recipients) are distinct and vulnerable and must therefore be safeguarded from substitute critical dose immunosuppressant drugs that have not displayed bioequivalence in thorough clinical trials in transplant patients.
As a result, Astella intends to issue a protest for declaratory and injunctive relief in U.S. District Court in Washington, where they hope to dispute the FDA’s choice to apply standard bioequivalence testing for the approval of generic immunosuppressant drugs.
Bioequivalence dose drugs has a limited therapeutic scope for welfare and effectiveness. Under the FDA’s settlement, bioequivalence testing only involves healthy volunteers, not the patients that will require treatment with the new product. Bioequivalence testing involves calculating how evenly matched the absorption of the active ingredients in generic drugs are with those of innovator drugs. Absorption, and the clinical effects of critical dose drugs are impacted by numerous components, such as other medication influences, and parallel medical conditions. Transplant patients are at a high risk for organ rejection and are more often than not coping with multiple medications.
In addition, Astella is also disputing the FDA’s rejection of their request for label changes. This change would demand that physicians be advised whenever a substituted oral formulation is about to be given to a transplant patient. This would enable the physician to regulate the need for additional drug blood concentration testing, further ensuring the patient’s safety.
