Owner of Meningitis-Linked Pharmacy Declines to Testify Before CongressLast Updated: November 14, 2012. FDA commissioner asks for more authority over specialty pharmacies like one linked to tainted injections.
By Steven Reinberg and Margaret Steele
WEDNESDAY, Nov. 14 (HealthDay News) -- The owner of the Massachusetts specialty pharmacy implicated in the meningitis outbreak that has killed 32 people declined to testify Wednesday before a Congressional committee investigating the matter, the Associated Press reported.
After a series of questions from members of the House Energy and Commerce Committee, Barry Cadden, co-founder of the New England Compounding Center, said: "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment."
The committee hearing focused on whether the outbreak, which has also sickened 461 people, could have been prevented.
Also Wednesday, U.S. Food and Drug Administration Commissioner Margaret Hamburg told the committee that new laws are needed to give her agency more legal authority and funding to oversee so-called compounding pharmacies, like the one in Massachusetts at the center of the deadly outbreak, the AP reported.
"The challenge we have today is that there is a patchwork of legal authorities that oversee the action we can take," Hamburg, who was nominated to head the FDA by President Obama in 2009, said in prepared testimony, the AP reported.
She said Congress should draft new laws and provide more funding to police large specialty pharmacies, such as the New England Compounding Center, which aren't subject to the same FDA scrutiny as big drug manufacturers.
"In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding," Hamburg said.
Republican lawmakers, who constitute the majority party in the House of Representatives, spent considerable time focusing on the New England Compounding Center's checkered past, asking Hamburg why regulators at the FDA and the Massachusetts board of pharmacy did not take action against the company several years ago, the AP reported.
Hamburg said problems uncovered in past inspections were "very serious," but that the FDA, under current law, was obligated to defer to Massachusetts authorities, who have more direct oversight over pharmacies in the state, the AP reported.
Compounding pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients. Such custom-made drugs may include a smaller dose, for example, or the removal of an ingredient that might trigger an allergy in a patient, according to the FDA.
Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers.
The New England Compounding Center in Framingham was the source of the tainted steroid injections, which are typically used for back and joint pain. The company has ceased operations since the meningitis outbreak first surfaced early last month.
Meningitis is inflammation of the lining surrounding the brain and spinal cord. Infected patients have developed a range of symptoms approximately one to four weeks following their injection.
On Thursday, Hamburg is scheduled to testify before the Senate Committee on Health, Education, Labor, and Pensions.
Last month, FDA investigators who toured the Framingham plant found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses, federal health officials said. The contaminated product was one of a host of potential violations discovered during the recent inspection, the officials said.
"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the FDA's Office of Manufacturing and Product Quality, said during an Oct. 26 news conference.
In addition, the company couldn't prove that the equipment used to sterilize these products was actually able to sterilize them, Lynn said.
The FDA also found that the company wasn't able to keep its "clean room" clean, Lynn said. "A clean room is a space designed to maintain a controlled environment with low levels of airborne particles and surface contamination," he explained.
The U.S. Centers for Disease Control and Prevention on Wednesday had the following state-by-state breakdown of cases: Florida: 23 cases, including 3 deaths; Georgia, 1 case; Idaho, 1 case; Illinois, 2 cases; Indiana: 53 cases, including 4 deaths; Maryland: 23 cases, including 1 death; Michigan: 148 cases, including 8 deaths; Minnesota: 12 cases; New Hampshire: 13 cases; New Jersey: 27 cases; New York: 1 case; North Carolina: 3 cases, including 1 death; Ohio: 16 cases; Pennsylvania: 1 case; Rhode Island: 3 cases; South Carolina: 1 case; Tennessee: 81 cases, including 13 deaths; Texas: 2 cases; Virginia: 50 cases, including 2 deaths.
Ten of the 461 cases involve what the CDC calls "peripheral joint infection," meaning an infection in a knee, hip, shoulder or elbow. These joint infections aren't considered as dangerous as injections near the spine for back pain that have been linked to the potentially fatal meningitis infections.
The CDC and state health departments estimate that roughly 14,000 patients may have gotten steroid injections from the New England Compounding Center. All of the fungal meningitis patients identified so far were thought to be injected with the steroid methylprednisolone acetate, according to the CDC.
People who have had a steroid injection since July, and have any of the following symptoms, should talk to their doctor as soon as possible: worsening headache, fever, sensitivity to light, stiff neck, new weakness or numbness in any part of your body or slurred speech, the CDC said.
The U.S. National Library of Medicine has more about injections for back pain.
SOURCES: Nov. 13, 2012, news release, U.S. Food and Drug Administration; Nov. 9, 2012, updated statistics, U.S. Centers for Disease Control and Prevention; Associated Press