A U.S. District Court judge in Washington, D.C. issued a decision that upheld FDA’s interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in drug compounding. We are pleased with the court’s decision, which is a victory for public health in the first such case since the Drug Quality and Security Act (DQSA) was enacted.
FDA had previously announced that vasopressin is not a “bulk drug substance for which there is a clinical need” because there is already a product on the market that is FDA-approved to meet patients’ medical needs. The agency, therefore, decided not to place the bulk drug substance vasopressin on a list of bulk drug substances that can be used in compounding by outsourcing facilities (the “503B Bulks List”). The court agreed, finding that the agency’s method of determining whether there is a “clinical need” for a bulk drug substance is consistent with the law. We will continue to evaluate bulk drug substances nominated for use in compounding by outsourcing facilities in accordance with our interpretation of clinical need.
Our compounding work remains a top priority at the agency. We’ve long recognized that compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. But compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety, efficacy or quality. We’ve seen first-hand the harm they can cause patients when they’re not appropriately compounded.
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