The FDA has been taking a tougher position on oversight of large compounding pharmacies after it was accused last year of doing too little to prevent a fatal outbreak of bacterial meningitis tied to one of the operations. But the agency again finds itself the target of criticism with reports that two patients have died and drugs from a Texas compounder are suspected in an outbreak of bloodstream infections.
Texas authorities told the Austin American-Statesman that the cause of death has yet to be established, but the two patients were among 17 who have developed the infections after getting infusions of calcium gluconate manufactured by Specialty Compounding of Cedar Park, TX.
The FDA this week had the compounder recall all of its sterile products manufactured since May 9, saying culture samples from the drugs contained bacteria. "The FDA believes that use of these products would create an unacceptable risk for patients," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Giving a patient a contaminated injectable drug could result in a life-threatening infection."
But the agency came under fire from Public Citizen, a public interest group that has been a critic of the FDA oversight of compounding pharmacies. In a statement Wednesday, it pointed out that the FDA found quality and sterility questions at the compounder's plant during an inspection in March. Had the agency sought a recall at that point, the infections might have been avoided, it said. Public Citizen has asked for an investigation. "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," said Michael Carome, director of Public Citizen's Health Research Group, in a statement.
Compounders traditionally were small operations that created custom drugs for hospitals and have been overseen by state authorities. But in the face of drug shortages, some have expanded nationwide and function more like drug manufacturers than pharmacies. After the meningitis outbreak last year that sickened hundreds, dozens fatally, the FDA began methodically inspecting the largest of the operations. But FDA Commissioner Margaret Hamburg has been called before both House and Senate committees to explain why the FDA had not done a better job of protecting citizens against poor-quality drugs made by compounders. She has said the FDA needs clearer authority and is supporting legislation pending in Congress that would establish that.
- read the Austin American-Statesman story
- here's the Public Citizen statement
- see the FDA recall