“The FDA should have closed a Texas compounding pharmacy in March shortly after inspectors found sterility problems, an action that would have prevented the recent hospitalization of 15 patients, public health advocates charged” recently. The statement by David Pittman, a MedPage Today correspondent, goes to the essence of what I’ve talked about in recent articles about the FDA and compounding pharmacies. The oversight and regulation of these manufacturers needs to be intensified. And it needs to happen before more people are harmed or killed as a result of unsterile, contaminated medical products.
According to the timeline reported in the story, the FDA inspected Specialty Compounding, near Austin, Texas in March of this year. This was a thorough inspection that took four days. And though it was reported to have found significant problems with the facility the FDA has yet to issue an alert or a recall. In fact it was early August, four months later, when the FDA filed its report with the Texas Department of State Health Services.
According to the FDA inspection report, employees were not preventing possible contaminations and were cited with a number of infractions which included picking up items on the floor while wearing gloves and then not changing the gloves.
“The FDA knew there was a serious problem here but didn’t use its existing legal authority to take prompt, aggressive enforcement action against the company. That exposed patients to unnecessary risk and might have contributed to 15 people being infected,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a press release. “What’s the purpose of inspecting a facility if you’re not going to take appropriate action when you find conditions that pose a safety threat to patients?” (MedPage Today, 8/14/13)
Congress is still debating legislation that would give the FDA more power to oversee compounding pharmacies in the wake of the recent New England Compounding Center problem. Legislators seem willing to give greater oversight when medications are shipped across state lines, but are slower to consider more comprehensive regulatory powers for compounding centers.
When lawmakers return from their late (and long) summer break they are hopefully will pass this bill. But we are still left with many questions about the FDA’s ability to provide the necessary regulation of compounding pharmacies in a timely fashion. For now, the FDA is not commenting on the Texas incident.