FDA Requests Additional Authority Over Compounders

Published Online: Friday, May 17, 2013
Follow Pharmacy_Times:
In testimony before a United States House Energy and Commerce subcommittee on April 16, 2013, FDA Commissioner Margaret Hamburg, MD, acknowledged that the agency could have taken more action against compounding pharmacies such as the New England Compounding Center, whose tainted steroids caused a deadly meningitis outbreak last fall. Nonetheless, Dr. Hamburg said the agency needs expanded authority in order to hold compounding pharmacies to stricter safety standards.

Dr. Hamburg expressed regret that the FDA had not been more aggressive, but said that it had held back out of concern that the FDA would be sued by the pharmacies it targeted. She testified that the agency needs the authority to require compounding pharmacies that make high-risk products to register with the agency and to submit to inspections and share their records, which currently requires a court order. In addition, she said that compounders should be forced to adhere to uniform federal safety procedures and, like large drug manufacturers, should be required to report problems with their products.

Republican members of the committee seemed wary of the request for increased authority, arguing that the agency had failed to act, despite many warnings of problems with compounding pharmacies, while Democratic members seemed more open to granting the additional authority.

Related Articles
The $200 million fund created to compensate victims of the 2012 meningitis outbreak tied to tainted drugs is an extreme example of how expensive compounding errors can be.
Compounding pharmacies across the nation face tighter regulations following the 2012 fungal meningitis outbreak from tainted drugs distributed by the New England Compounding Center.
As news of FDA Commissioner Margaret A. Hamburg’s resignation spread, pharmaceutical organizations commended her work as a patient safety advocate, particularly regarding drug approvals.
The news of Margaret A. Hamburg, MD, resigning from her long-standing post as FDA Commissioner stirred memories of her success with improving access to emergency contraception, but more so her struggles with regulating drug compounding following a deadly fungal meningitis outbreak traced to a compounding pharmacy’s tainted drugs.
Latest Issues