Lawmakers have released a report on the FDA’s interactions with the compounding pharmacy linked to a nationwide outbreak of fungal meningitis infections, revealing deep concerns within the agency over the safety of the facility as early as 2002, and indicating that efforts to shut the pharmacy down failed due to state intervention.
The House Energy and Commerce Committee unveiled a detailed timeline of inspections and investigations of the New England Compounding Center (NECC) (pdf), which highlight multiple issues identified by FDA investigators over a decade ago.
Some of those concerns specifically focused on the likelihood of a problem with fungal meningitis outbreaks.
The report comes before a hearing scheduled today with the committee, during which health officials are expected to testify about why no action was taken to prevent the outbreak, when FDA investigators first raised red flags about a possible fungal meningitis outbreak in 2002.
According to the report, the FDA investigator and a supervisor met with Massachusetts state health officials in 2003, to discuss whether NECC should be considered a compounding pharmacy or a drug manufacturer given the amount of drugs it produced.
FDA officials recommended that the “firm be prohibited from manufacturing until they can demonstrate ability to make product reproducibly and dependably” following numerous citations and concerns over sterility and safety.
According to the House report: The February 5, 2003, meeting concluded by FDA “emphasizing the potential for serious public health consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.”
The FDA ultimately deferred to the state’s judgment, which later cut a deal allowing NECC to continue to function more or less as it had been. The state “did not commence any regulatory actions until well over a year later, on September 21, 2004, when the Board voted unanimously in favor of proposing a consent agreement to NECC,” the report notes.
Fungal Meningitis Outbreak Has Sickened Hundreds and Killed Dozens
In September of this year, federal and state health agencies tied NECC’s epidural steroid injections to a fungal meningitis outbreak which has now killed more than 30 people and sickened more than 400 people throughout the United States.
The compounding pharmacy has now been shut down, issued a steroid injection recall, and later recalled all of its products and lost its license. However, congressmen say they hope to determine just why the compounding pharmacy was allowed to continue operating when the problems that led to the outbreak were recognized at least 10 years ago.
The commissioner of the FDA, Dr. Margaret A. Hamburg, and the president and co-owner of NECC, Barry Cadden, are among those scheduled to testify.
A number of fungal meningitis lawsuits are now being pursued on behalf of individuals who received a steroid injection from NECC, however substantial concerns exist about the ability of this company to properly compensate all of the people who have been damaged.
NECC distributed an estimated 17,000 shots of the recalled epidural injection, and CDC estimates that about 14,000 people were exposed to the potentially tainted drugs. The FDA has also confirmed that contaminants have been found in additional products compounded by the pharmacy.
A petition has been filed to consolidated the federal compounding pharmacy litigation against NECC as part of an MDL, or multidistrict litigation. However, some plaintiffs have asked for an expedited process due to concerns over NECC’s ability to cover the mounting claims and rumors that the company will be filing bankruptcy in the near future.