American-Statesman Staff
A consumer group is asking the federal government to stop a compounding pharmacy in Cedar Park from making or distributing any products until it complies with laws and regulations aimed at preventing drug contamination.
Public Citizen, created by activist and former presidential candidate Ralph Nader, also is asking U.S. Health and Human Services Secretary Kathleen Sebelius for an inspector general’s investigation of the Food and Drug Administration for allowing Specialty Compounding to continue operating after a March inspection. FDA representatives identified several concerns about possible contamination of sterile drugs, most of which are injected, during the inspection.
The company initiated a voluntary recall Friday of all of its sterile products — an estimated 50 drugs — after 15 patients at two Corpus Christi hospitals had blood stream infections. The patients had been injected with the company’s calcium gluconate product, used to treat low-calcium conditions.
The FDA is investigating the infections and has signaled the drug is the probable cause but has not made a final determination.
“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,” the Public Citizen letter dated today says. “It can prevent future injuries by exercising its authority more aggressively when it identifies problems during an inspection.”
Company spokesman David Ball said Wednesday he would review the letter before responding.
In an interview yesterday, Ball said the firm is cooperating fully with the FDA. The company also said it took corrective action on the inspectors’ concerns and issued the recall “in an abundance of caution.”
The letter says Public Citizen is seeking a “permanent injunction against Specialty Compounding, preventing it from producing and distributing sterile drug products until it complies with all applicable federal laws and regulations. We also call for you to request that the Inspector General conduct an investigation to determine why the agency did not request an earlier voluntary recall, issue a public safety alert, or seek an injunction after the FDA inspectors identified multiple sterility concerns during an inspection of Specialty Compounding in March 2013.”
It urges action on other pharmacies with similar problems as well.
“The FDA has identified “significant objectionable conditions” at 50 compounding pharmacy facilities since fall 2012, yet only 16 of these facilities have initiated a product recall or been the subject of an FDA enforcement action.”
The FDA had been under fire from Congress and others alleging lax regulation of compounding pharmacies, companies that mix drugs based on doctors’ prescriptions. Earlier this year, the FDA conducted surprise inspections of 31 such businesses it considered to be at risk for possible contamination of drugs. Specialty Compounding was one of them.
Here is a link to the letter: http://www.citizen.org/documents/2148.pdf
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