Call it FDA déjà vu. While Congress continues to spar with the FDA over its oversight of compounding pharmacies, agency officials are running down yet another outbreak of possible infections tied to a potentially contaminated steroid manufactured by a compounding pharmacy.
The agency said in an alert that there have been 7 reports of adverse reactions after patients received injections of preservative-free methylprednisolone acetate, manufactured by Main Street Family Pharmacy, a compounding pharmacy in Newbern, TN. That is the same drug at the heart of the fungal meningitis outbreak that began last year and at last count had sickened 741 people, 55 fatally. The FDA is still figuring out what has caused the recent reactions but told providers to quarantine the drug because it is a "potentially contaminated medication."
A voluntary nationwide recall of all of the company's sterile drugs was issued Wednesday.
State officials said there were reports of skin abscesses, NBC News reported. "Fortunately, we are aware of no serious events like meningitis, stroke or death in association with this cluster," Tennessee state health commissioner Dr. John Dreyzehner said in a news briefing NBC News reported. But the FDA said at least one of these adverse events appears to involve fungus. In a statement, the company said, "As the FDA reported, an investigation into the exact source of the potential adverse effects from the methylprednisolone acetate is inconclusive and ongoing. The company is fully supportive and compliant with the FDA's recommendation that a voluntarily recall take place and patients not be administered this compounded medicine until the investigation is complete."
The FDA continues to face criticism from some members of Congress for not taking a more aggressive attitude toward compounding pharmacies after the outbreak tied to the now-defunct New England Compounding Center cut a path of infection and death through much of the U.S. FDA Commissioner Margaret Hamburg has said the FDA's authority over compounders is ambiguous. They traditionally were overseen by state authorities. The agency nonetheless started a crash campaign to inspect the 30 largest compounding pharmacies in the U.S., many of whom have recalled drugs after the FDA said questionable sterility practices in their manufacturing might lead to contamination.
Hamburg has asked Congress to pass a law that gives the FDA clear authority to oversee the largest compounders. A bipartisan Senate bill making its way through Congress would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs. It would not require the compounders to meet all of the strict regulations that drug manufacturers do, like getting preapproval of their products and labels. It would, however, prevent them from any longer making the most complex biologic drugs that are more easily contaminated. They also would not be allowed to make their own versions of FDA-approved drugs unless there was a shortage. And like manufacturers, they would have to kick in fees for the privilege of having FDA supervision.
Hamburg faces Senate as new compounding regulations progress
Hamburg to face Congress again over compounding lapses
FDA now inspecting 'high risk' compounders
Third compounder in week recalls products
Hamburg, FDA inspection practices go under microscope in meningitis outbreak
Editor's Note: The story was updated to include the nationwide recall of Main Street's sterile drugs and to include the company's statement.