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Compounding Pharmacists Oppose Greater U.S. Oversight
Date:11/15/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

THURSDAY, Nov. 15 (HealthDay News) -- The head of the lobby that represents compounding pharmacies will tell a U.S. Senate committee Thursday that tighter federal regulations aren't needed to oversee his industry, despite the ongoing meningitis outbreak that has killed 32 people and has been linked to tainted medications made by a compounding pharmacy.

The Associated Press reported that the head of the International Academy of Compounding Pharmacists will testify that existing regulations, which primarily put oversight responsibility on individual states, are enough to monitor compounding pharmacies.

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 U.S. Food and Drug Administration.

These specialty pharmacies aren't subject to the same FDA oversight as regular drug manufacturers. But some members of Congress are calling for greater FDA oversight in response to the meningitis outbreak linked to contaminated steroid injections made by a Massachusetts compounding pharmacy. Besides the 32 deaths, the outbreak has sickened 461 people in 19 states.

But David Miller, chief executive officer of the compounding pharmacies' lobbyist group, will tell the senators that current state laws, if enforced, would have prevented the meningitis outbreak. And the Massachusetts company in question, the New England Compounding Center in Framingham, was shipping medication without first receiving prescriptions from doctors, a violation of its state-issued pharmacy license, Miller said in prepared testimony, the AP reported.

"The operations of NECC were clearly outside of the scope of the state's licensure requirements and their license should have been pulled long ago," Miller said, according to the AP.

The International Academy of Compounding Pharmacists has spent more than $1 million lobbying Congress in the last 10 years and has successfully defeated laws and regulations opposed by the compounding industry, the AP reported.

On Wednesday, the owner of the New England Compounding Center refused to testify before a House of Representatives committee that's also investigating the steroid/meningitis outbreak.

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 AP reported.

But FDA Commissioner Margaret Hamburg told the House committee Wednesday that new laws are needed to give her agency more legal authority and funding to oversee compounding pharmacies.

"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.

Last month, FDA investigators who toured the New England Compounding Center's 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 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.

More information

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. 14, 2012, updated statistics, U.S. Centers for Disease Control and Prevention; Associated Press


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