The growth of New England Compounding into a pharmacy of national scope, operating beyond what its state license allowed, did not happen out of view of state and federal regulators. In meticulous detail, Liz Kowalczyk and Todd Wallack in Sunday’s Globe outline how a Walgreens pharmacist became a major player in a competitive market and how health officials repeatedly failed to act on signs that the pharmacy posed a threat to patients.
One day in April 2002, inspectors noted that [owner Barry] Cadden had stored a 1,000-milliliter beaker of betamethasone — the steroid believed to have sickened at least two patients — in a protective hood while awaiting results of sterility tests, which could take a week. Cadden had covered the beaker with several sheets of aluminum foil.Advertisement - Continue Reading Below
Investigators warned the solution could become contaminated sitting out that long, but Cadden said he did not want “to waste money” on vials until he knew the product was sterile and could be sold. At a meeting a week later, Cadden told investigators the beaker did not contain betamethasone at all.
Federal and state officials inspected New England Compounding nine times in 2002 and 2003, and the FDA issued the pharmacy two form 483s — a formal list of concerns observed during inspections — identifying problems with the sterilization and mixing of drugs.
In response to one, Cadden said he had hired a consultant and taken a series of corrective actions, including sanitizing work spaces on a regular schedule and cleaning and testing the autoclave, used for sterilizing equipment.
The investigation occurred amid the unfolding tragedies in California and South Carolina. These cases were a key component of the FDA’s presentation to state pharmacy regulators at the February 2003 meeting.
The agency’s officials wanted to impress on the pharmacy board “the potential for serious public health consequences if NECC’s compounding practices, particularly those relating to sterile products, are not improved,’’ David Elder, then director of compliance for the agency’s New England office, told the group, according to a memo summarizing the meeting.
Thirteen patients were hospitalized, including five with meningitis, and three died, after receiving injections of the steroid betamethasone made by Doc’s Pharmacy in Walnut Creek, Calif. — cases that came to light in the summer of 2001. In South Carolina the next year, four patients contracted fungal meningitis from methylprednisolone made by Urgent Care in Spartanburg, and at least one died.
During the meeting, the FDA also pointed out that an April 2002 US Supreme Court ruling had weakened its authority over compounding pharmacies, while leaving intact its power to regulate manufacturers.
Though New England Compounding had begun its national expansion by that time, the regulators, for reasons that are unclear, decided the company was still a compounder, and the FDA handed over primary oversight responsibility to the state.