The risk of patient illnesses were spotted by U.S. regulators more than a decade ago at the pharmacy linked to this year’s deadly meningitis outbreak, according to lawmakers investigating the government’s response.
Procedures at New England Compounding Pharmacy Inc., known as NECC, may not have met standards for sterility, according to Food and Drug Administration inspection records from 2002 summarized by a House panel. At the time of the FDA’s inspection, conditions at the Framingham, Massachusetts, facility were found to be similar to a California compounding pharmacy associated with three meningitis deaths a year earlier.
The regulators also said in 2002 that a hospital in Rochester, New York, linked an NECC pain-killing steroid, methylprednisolone acetate, to meningitis-like symptoms in two patients. The same drug is blamed for this year’s outbreak, which has infected 438 people, killing 32. While the FDA in 2002 suggested suspending operations, the law kept it from acting and the agency deferred action to Massachusetts authorities.
“The state would be in a better position to gain compliance or take regulatory action against NECC as necessary,” the FDA said in a February 2003 memo summarized yesterday by a subcommittee of the House Energy and Commerce Committee. The decision was made even as the FDA cited “the potential for serious public health consequences.”
The Energy and Commerce subcommittee on oversight and investigations plans a Nov. 14 hearing to ask FDA Commissioner Margaret Hamburg why the agency didn’t pursue enforcement actions and how Massachusetts officials allowed NECC to keep its license. U.S. Representative Fred Upton, a Michigan Republican and chairman of Energy and Commerce, also sent a subpoena to NECC co-owner Barry Cadden.
The Senate’s health committee plans a hearing Nov. 15.
NECC was a specialty pharmacy permitted to mix drugs on a small scale that patients may not have been able to find elsewhere, such as those without preservatives or in a unique dose. It suspended operations Oct. 3 and recalled 17,676 doses of methylprednisolone acetate after regulators determined that tainted vials of the drug were responsible for fungal meningitis infections in 19 states.
Inspections by the FDA last month showed the company knew of elevated levels of mold and bacteria in January and “no documented corrective actions were taken,” according to a preliminary report that cited company documents.
The same steroid linked to the current meningitis outbreak also was the subject of some of the 2002 inspections. FDA tests in December 2002 found that four of 13 vials of methylprednisolone acetate tested positive for bacteria, though no deaths were linked to the products.
Meningitis is an inflammation of the lining of the brain and spinal cord. The government has said about 14,000 people received shots of the NECC steroid, which is injected into the spinal cavity to relieve neck and back pain.
Ameridose LLC, a drug distributor with the same management as NECC, also failed to investigate microbiological contamination observed at least 53 times during sterility testing of solutions intended for use in sterile injectable drugs, the FDA said yesterday in a separate inspection report.
The Westborough, Massachusetts-based company also received 33 complaints that drugs it made weren’t as potent as they should be and were ineffective, the FDA said. The inspections were from Oct. 10 through Nov. 9.
NECC’s relationship with regulators has been rocky from the start. The first government complaint was filed against NECC by Massachusetts regulators in 1999 -- less than a year after it came into existence -- for providing doctors with blank prescription pads referring to the pharmacy.
Massachusetts regulators waited until “well over a year” after a February 2003 meeting with FDA officials to vote in favor of presenting Cadden, NECC’s owner, with a consent agreement that would detail policies and procedures to be followed by the pharmacy. The agreement required an inspection by an independent auditor, Pharmacy Support Inc.
In January 2006, the auditor said that while NECC had made “significant upgrades in facility design for sterile compounding” there were still “numerous significant gaps identified.” In April 2006, the auditor’s final report said the pharmacy had “demonstrated the ability to be compliant with all state and federal regulations,” even though NECC should redesign the clean room where sterile preparations were made.
Massachusetts pharmacy regulators absolved NECC of the terms of the consent agreement in May 2006 and didn’t share the auditor’s report with the FDA, according to the document.
Despite dissolution of the consent agreement, FDA sent a warning letter to NECC in December 2006 for allegedly copying commercially available drugs and acting like a drug manufacturer, particularly in ways that could cause microbial contamination. Cadden responded in January 2007 that the letter corresponded with an inspection FDA conducted starting in September 2004 and some of the assertions no longer applied.
The FDA didn’t respond until October 2008 and said it would confirm Cadden’s response in a follow-up inspection though the letter was the last documented correspondence between the two until the recent outbreak, according to committee’s report.
Recent revelations of a Colorado complaint that were largely ignored resulted in the firing of James Coffey, director of the Massachusetts’ pharmacy board, according to a Nov. 7 statement from Lauren Smith, interim commissioner of the state’s Department of Public Health. Coffey failed to initiate an investigation after Colorado officials notified him in July that NECC sold drugs without patient-specific prescriptions in the state.
Susan Manning, counsel for the Massachusetts pharmacy board whom Coffey forwarded his correspondence with a Colorado inspector, was placed on administrative leave.