FDA Knew About Specialty Compounding Problems Before Infections

A consumer watchdog group is suggesting that federal drug regulators again squandered an opportunity to prevent infections caused by unsterile drugs distributed by a single compounding pharmacy.  

On August 14, Public Citizen wrote a letter (PDF) to Secretary Kathleen Sebelius, head of the U.S. Department of Health and Human Services, which oversees the FDA, to complain that FDA inspectors knew of problems at the Specialty Compounding pharmacy before a series of bacterial infections that led to a recall last week.

The FDA announced a Specialty Compounding, LLC drug recall on August 9, warning that the Cedar Park, Texas, compounding pharmacy’s drugs may not be safe. The recall came following reports that at least 15 patients at two Texas hospitals fell ill after receiving IV infusions of calcium gluconate that were mixed at the pharmacy.

According to an FDA inspection report (PDF) dated March 18 of this year, the agency knew months ago that there was a problem but failed to act. The report lists actions by employees that endangered the sterility of the drugs and noted that the company was lacking in a number of practices that were necessary to make injectable drugs safe.

“Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing,” the March inspection report states. “Specifically, your firm does not conduct routine sterility or endotoxin testing for all injectable drug products currently produced.”

In Public Citizen’s letter to Secretary Sebelius, the group calls for her to direct the FDA to review its inspections of compounding pharmacies this year and to take action against those with deficiencies similar to the ones found at Specialty Compounding before another bacterial infection outbreak threatens patients.

The letter comes at a particularly sensitive time for the FDA, which is under fire for failing to act to prevent a fungal meningitis outbreak that began last year and killed more than 60 people and sickened more than 700 nationwide. The outbreak was traced back to the New England Compounding Center (NECC) and epidural steroid injections it distributed last year. But FDA records indicated that the agency and state health officials in Massachusetts knew NECC had problems for years and even predicted there was a danger to the public.

The FDA came under fire from lawmakers and other critics who said it failed to use its power to protect the public by taking action against NECC, but the agency said it did not have the proper authority. Legislation is currently being considered that lawmakers and health officials hope will clarify the FDA’s authority over compounding pharmacies.