U.S. and Massachusetts state health regulators were aware in 2002 that steroid treatments from the pharmacy at the center of a deadly meningitis outbreak could cause adverse patient reactions, congressional investigators said on Monday.

The U.S. House of Representatives Energy and Commerce Committee said complaints about preservative-free methylprednisolone acetate were partly responsible for joint state and federal inspections of the New England Compounding Center's (NECC) Framingham, Massachusetts facility in 2002 and 2003.

It is the first indication that health officials knew of potential problems with the specialty pharmacy's production of the drug before tainted versions were linked to fungal meningitis earlier this year.

The House committee is investigating the meningitis outbreak amid calls for tighter FDA scrutiny of pharmacies like NECC, which produced large quantities of drugs for sale nationwide while operating outside federal safety and efficacy regulations for drug manufacturers.

Officials at NECC and FDA were not immediately available for comment.

Steroid treatments are now implicated in 294 fungal meningitis cases, 23 of them fatal, that have so far been reported for patients who received the drug for back and neck pain, according to federal officials. As many as 14,000 people may have been exposed to the treatment. Health officials are also investigating other problems that may have been caused by additional drugs from the same pharmacy.

The House committee, which has oversight of drug safety issues, said Massachusetts public health officials informed its staff about the 2002 and 2003 inspections during a closed-door October 18 briefing.

In a letter to an attorney for NECC, Republican committee Chairman Fred Upton and other panel members said NECC signed a January 10, 2006, consent agreement as "settlement of complaints related to an adverse complaint report investigated by the (FDA) for methylprednisolone acetate preservative free."

FDA issued its own warning letter to NECC in 2006, pointing to potential health risks from other products.

The House committee did not provide details about the adverse incident except to say that it was reported via the FDA's MedWatch system, which collects reports of problems with drugs and medical devices. But it said inspections called into question whether NECC was operating as a traditional compounding pharmacy or as a drug manufacturer.

"The committee seeks to determine how long the NECC has been operating in this manner and why, six years after FDA's warning letter and 10 years after warnings relating to methylprednisolone acetate ... the company was able to continue doing so," lawmakers said in an October 22 letter to NECC attorney Paul Cirel.

The committee sent a similar letter to NECC co-owner Barry Cadden.

The lawmakers said NECC and Cadden failed to respond to an earlier request for a briefing with committee staff and called on the company to produce records dating back to 2002 no later than November 5.

The list of requested documents includes state and federal inspection reports, consent agreements, communications between regulators and NECC as well as the companies Ameridose LLC and Alaunus Pharmaceutical LLC, which share similar ownership.

Related stories:

Fungal meningitis clues may predict who gets sick

Fungal meningitis outbreak tied to steroid shots isn't the first

AP

Vials of the injectable steroid product made by New England Compounding Center.

By Mike Stobbe
The Associated Press

The fungus found in tainted steroid shots matches the one behind the national meningitis outbreak that has killed 20 people, federal health officials said Thursday.

The match confirms the link between the outbreak and the maker of the steroids, New England Compounding Center of Framingham, Mass. Officials previously said they found fungus in more than 50 unopened vials from the company, but needed more tests to determine the kind of fungus.

The specialty pharmacy has been at the center of a federal and state investigation into more than 250 fungal meningitis cases. The death toll rose Thursday to 20.

The victims in the outbreak had all received steroid shots made by the pharmacy, mostly to treat back pain. The company last month recalled three lots of the steroid made since May. It later shut down operations and recalled all the medicines it makes.

The fungus was confirmed in one steroid batch made in August, according to the Food and Drug Administration and the Centers for Disease Control and Prevention. The CDC has linked outbreak illnesses to all three lots; tests are continuing on the other two lots.

The initial recall involved about 17,700 single-dose vials of the steroid sent to clinics in 23 states. As many as 14,000 people got shots from the three lots.

The company released a statement Thursday afternoon that said, in part; "We are eager to review these findings as part of our continued cooperation with the CDC and FDA to identify the cause of this contamination."

The fungus in the vials — Exserohilum rostratum — is the same as that found in at least 45 people sickened with fungal meningitis.

"We were able to link the organism in these vials to the organism in the patients," said the CDC's Mary Brandt, whose lab did the testing.

The FDA-CDC announcement did not say how many tested vials had that kind of fungus.

Exserohilum is common in dirt and grasses, but it rarely causes illness and has never before been identified as a cause of meningitis, CDC officials have said.

Meningitis is caused by the inflammation of protective membranes covering the brain and spinal cord. Tainted spinal injections would directly put germs into that part of the body.

Also on Thursday, the CDC said New York has reported a fungal illness, making it the 16th state with outbreak cases. The others are Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

Officials say 254 of the cases are meningitis related to shots for back pain. Three others are infections in the joints, including the New York case.

The new death reported was in Michigan, bringing its total to four.

More coverage of meningitis outbreak:

• Fungal meningitis can destroy brain fast, first case history shows
• Fungal meningitis outbreak isn't the first
• FDA: Check all who got suspect pharmacy drugs