Regarding the Feb. 8 front-page article “Problems cited for years at drug firms”:
Patient safety is PharMEDium’s highest priority, and we are committed to maintaining the highest levels of quality and safety in sterile preparations. To that end, we have actively supported Food and Drug Administration (FDA) oversight of the compounding industry. In addition, none of our preparations has ever been linked to a patient’s death, nor were the company’s facilities cited by regulators for “alarming conditions.” Readers of The Post’s story might conclude otherwise, and we feel it is important to clarify key items.
We are not part of any industry effort to challenge the FDA’s jurisdiction or undermine the agency’s oversight. We have long advocated for strengthened FDA oversight and urged Congress to take such action, including the adoption of rigorous national quality and safety standards.
Our four centers are registered with the FDA, adhere to FDA guidelines and operate above applicable national standards for sterile compounding. The FDA routinely inspects the centers, and we have been fully responsive. The reported 2005 contamination incident was investigated by the FDA and immediately addressed by the company.
We remain committed to improving our processes and serving as a resource to policymakers as they try to understand the tragic meningitis outbreak and ensure that nothing like it never happens again.
Thomas Rasnic, Lake Forest, Ill.
The writer is vice president for quality, regulatory and research and development matters at PharMEDium Services.