Public Citizen last month requested the U.S. Department of Health and Human Services (HHS) to halt operations at Specialty Compounding LLC after at least 15 patients were sickened by one of the Texas compounding pharmacy’s products, saying the government had known of problems at the company. The consumer advocacy group said in a letter to HHS Director Kathleen Sebelius that the U.S. Food and Drug Administration (FDA) should permanently enjoin the company from producing medical products until it’s found to be complying with federal health regulations. I agree with Public Citizen that the FDA should have taken swifter action after a March 2013 inspection when the agency criticized the company for poor quality-control standards.
Public Citizen said in the letter that the pharmacy may have violated federal requirements requiring it to “follow good manufacturing practices and obtain FDA premarket approval before selling the product.” The letter, citing the March 2013 report, said:
The quality and volume concerns that FDA inspectors identified at Specialty Compounding during the March 2013 inspection, combined with the recent reports of bacterial infection potentially associated with Specialty Compounding products, suggest that the facility violated one or both of these federal requirements.
Specialty, a subsidiary of Peoples Pharmacy Inc., had in early August recalled all of its sterile medications after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included intravenous infusions of calcium gluconate from Specialty Compounding. The FDA said that cultures from an intact sample of calcium gluconate compounded by Specialty Compounding showed growth of bacteria consistent with Rhodococcus, which, according to the U.S. Centers For Disease Control and Prevention (CDC), can cause infections in people with compromised immune systems.
Specialty has said there is a potential association between the infections and the medication, and if there is microbial contamination in products intended to be sterile, patients are at risk of serious infections that may be life-threatening. In the March inspection, the FDA alleged Specialty violated good manufacturing practices. During one visit to the company’s plant, an inspector saw employees wipe their foreheads and then continue filling vials without changing gloves, according to an agency report.
In another instance, a pharmacist was spotted on hands and knees trying to retrieve fallen vials, and after grabbing them, returned to work in a so-called clean room, according to the report. Other alleged violations included a lack of written procedures for sterilization of gowns, insufficient sampling of work surfaces to ensure sterility and an unsatisfactory approach to cleaning and disinfecting. Public Citizen said in its letter that the FDA may have been able to prevent the recent outbreak had it taken more decisive action against the company after the March inspection. The letter said:
The FDA could potentially have prevented the current outbreak linked to Specialty Compounding products by taking swift action against the company after the FDA inspected its facility in March 2013. It can prevent future injuries by exercising its authority more aggressively when it identifies problems during an inspection.
The Alabama Department of Public Health has warned health care professionals in the state not to use any sterile products from Specialty Compounding. This came after the nationwide recall of medications by the company. Some supplies have been shipped directly to patients in Alabama. Those patients were supposed to be contacted directly by the company. An alert was sent to Alabama providers, including hospitals and pharmacists, on August 19th. The Department’s release states:
Individuals should contact their health care provider if they have used any sterile medications shipped from this pharmacy since May 9, 2013, and are experiencing any symptoms that may be related to taking these medicines. Even in the absence of symptoms, these patients should stop using these products and contact their health care providers to get replacement medications.
It will be most interesting to see how Congress reacts to another serious health risk caused by an industry that is virtually unregulated. It appears Public Citizen’s request for a shutdown has merit and the FDA should do so. In the meanwhile, to return product or request assistance, users should contact Specialty Compounding at 512-219-0724, Monday through Friday, between 10:00 a.m. and 5:00 p.m. CDT.
Sources: Law360, AL.com and Public Citizen
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