“NECC was in fact evading necessary regulation in part by purporting to be a compounding pharmacy,” he said.
Last fall, people that received steroid injections from the New England Compounding Center began to get sick with fungal meningitis and die. Investigations have since shown that the compound pharmacy was producing products too quickly, with one employee telling 60 Minutes that the company “got greedy” and eventually began to overlook cleanliness as more orders came in.
Hoey says that compound pharmacies – which mix custom versions of drugs for patients and require a single prescription – have adequate state and federal level protections in place.
“The Food and Drug Administration (FDA) and the Massachusetts Board of Pharmacy had adequate authority to take action against NECC. They could have acted to mitigate or potentially even prevent patient suffering,” said NCPA Chief Executive B. Douglas Hoey. “Sadly, they did not.”
Since compounding pharmacies can manufacture a single, specific FDA-approved medication liquid for someone unable to take pills, or flavor a child’s prescription to make it more palatable, the FDA does not have oversight of these facilities. The “60 Minutes” report concludes that this leaves the $2 billion industry to state regulators.
FDA Commissioner Margaret Hamburg told “60 Minutes” that she does not know the number of compound pharmacies in the country, or how many drugs they manufacture. But she said a lack of federal oversight will ultimately result in more deaths in the future.
But Hoey noted that the FDA “has endorsed compounding pharmacies’ role in alleviating drug shortages.”
“Without these providers, many thousands of patients would not have access to these medications and parts of the U.S. health care system would come to a standstill," he said.