Congressional report calls for FDA to regulate large compounders

The drumbeat is getting louder to have the FDA regulate at least those compounding pharmacies that are operating like small-scale manufacturers. And the FDA is singing the chorus saying if Congress is ready for that kind of oversight, it is prepared to take it on.

A report calling for FDA oversight has come out of the office of Edward Markey, a U.S. Representative from Massachusetts, where New England Compounding Center (NECC) its based, Reuters reports. It is NECC's steroid that is believed to be the source of meningitis that has infected 337 people in 18 states, 25 of whom have died. The report said that states are not equipped to do the kind of stringent oversight needed for the larger compounders like NECC that manufacture large quantities of drugs and distribute them widely.

FDA Commissioner Margaret Hamburg, in a statement to Reuters, appeared ready for the agency to take on the responsibility. She pointed out there has been equivocation in Congress in the past over how much authority it wants a federal agency to impose on compounders. She said the FDA is committed to working with Congress to realize "the authority we need to help prevent tragedies like this from happening again."

The FDA was called in to inspect NECC after the outbreak, even though compounding pharmacies are generally overseen by states. Hamburg's statement comes days after the agency issued a 483 inspection report on NECC where it found a long list of problems pointing to unsterile conditions in areas where drugs were manufactured. While company documents showed NECC was buying sterile APIs, employees indicated it was not. A sample of 321 vials in bin of methylprednisolone acetate that had been shipped to customers between Aug. 17 and Sept. 25, found 83 contained a "greenish, black foreign matter," while another 17 contained a "white filamentous material." The samples were of the drug suspected in the outbreak. The inspection found soiled floor mats and a tarnished sterilizing autoclave. Even NECC documents noted many times when sterile sampling found bacteria. The FDA said there was no indication the company followed up to identify them or their source.  

Markey's report indicated that the FDA does not have the unquestioned authority to conduct regular inspections and take action against compounders that do not comply with federal regulations, a shortcoming he plans to try to address by introducing legislation when Congress returns after next week's elections.

"Absent clear new authority, FDA's efforts will ultimately be constrained by gaps in regulatory authority and thwarted by an industry that has historically resisted a federal role for the oversight of its activities," Markey said.

- read the Reuters story 
- here's the FDA inspection report

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