Report says states not adequately tracking drugs
Says oversight of pharmacies lax
Compounding pharmacies in at least 49 states are not required to report the quantity of drugs they produce or where the drugs are shipped, according to survey results set to be released by Representative Edward J. Markey's office Monday.
The report, being issued in advance of a US House hearing Tuesday on oversight of the specialty pharmacies, describes a patchwork of state policies under which regulators wait for complaints about faulty drugs, rather than work proactively to ensure medications mixed at the facilities are safe.
Contaminated injectable steroids made at a Framingham compounding pharmacy have sickened more than 700 people since last year, at least 53 of whom have died. The outbreak of fungal meningitis and other serious infections prompted Markey and other lawmakers to call for federal oversight of pharmacies found to be operating more like drug manufacturers, as the New England Compounding Center was.
Only two states, Missouri and Mississippi, required a specific license for compounding pharmacies, according to the report, which included results from every state but Rhode Island.
Compounding pharmacies traditionally have been allowed to mix drugs for individual patients who need formulations or doses that are not widely available off the shelf. But the New England Compounding outbreak highlighted the fact that some were instead producing large batches of drugs, including medications that must be made in controlled, sterile environments. These can include injectable and intravenous drugs, and eye drops.
"In states from coast to coast, compounding pharmacies are going untracked, unregulated, and under-inspected, exposing patients everywhere to tainted drugs, disease, and death," Markey, a Democratic candidate for Massachusetts' vacant US Senate seat, said in a press release. "Even states with stronger compounding standards cannot effectively police the activities of pharmacies in 49 other states that sell drugs across state lines, which is why the [US Food and Drug Administration] must step in and protect public health."
Over the past three months, the FDA identified 31 sterile compounding facilities, considered to be high risk because of a history of problems, where it planned to conduct surprise inspections. A report posted on the agency's website Thursday said four initially refused to allow the federal inspectors to review records or their sterile compounding processes. At two others, the FDA had to secure warrants to complete the investigation. Among the problems that inspectors found were dirty work spaces, poor storage of drugs, and inadequate safety testing.
None of those targeted by the FDA was located in New England. But the report prepared by Markey's staff, called "State of Disarray," highlights how regulators have no way of quickly determining where a compounding pharmacy has shipped a drug that is found to be tainted.
When Pallimed Solutions Inc., for example, began a recall last month after state inspectors found visible contaminants in vials of drugs, the Woburn company said it had shipped products to patients or doctors in up to 21 states. The pharmacy was not properly licensed to operate in at least eight states identified in the recall, a Globe review found.
The survey asked state pharmacy boards to indicate whether inspections over the past decade have found problems like those at the New England Compounding Center, including contamination and bulk manufacturing, at the facilities they license. But 22 states did not have historical inspection records or did not track compounding problems. Such limited record-keeping makes it "difficult, if not impossible, for the states to identify compounding pharmacies with systemic, repetitive compounding safety problems," the report said.
The International Academy of Compounding Pharmacists has said oversight of compounding pharmacies should rest with the states, but that state pharmacy boards can do more, such as conducting regular unannounced inspections.
"State regulations and policy across the nation are changing day by day in response to the NECC tragedy," said spokesman David Ball, who had not seen the congressional report.
Markey has called for compounding pharmacies that operate like drug manufacturers to be subject to federal oversight. A spokesman said he plans to resubmit his legislation with changes to reflect the findings of the latest report.
A House Energy and Commerce subcommittee, of which Markey is a member, will hold a hearing on the issue Tuesday morning.