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Senators fault FDA on Ameridose

On Behalf of | Nov 15, 2012 | Fungal Meningitis

WASHINGTON — During the second day of congressional hearings into a fatal meningitis outbreak blamed on a Framingham pharmacy, senators said regulators not only failed to move aggressively against New England Compounding Center, but also a sister company that supplies drugs to thousands of hospitals nationwide. As a result of a problematic 2008 inspection of Ameridose LLC, a large-scale drug compounder in Westborough, Food and Drug Administration investigators recommended that the agency issue a warning letter to the company, according to a report prepared by the staff of the Senate Committee on Health, Education, Labor, and Pensions, which held the hearing.

Among other concerns, inspectors found that products were shipped immediately without waiting for test results showing they were sterile.

Yet no warning letter was ever issued.

The committee staff also said that Ameridose has been the subject of at least nine reports to the FDA of adverse events, faulty products, or medication errors in the last decade, but “it is unclear if any of these triggered an inspection or investigation.”

“This is in many respects more serious from a federal enforcement standpoint,” said Senator Richard Blumenthal, a Connecticut Democrat. “This is a company many times the size of [New England Compounding Center] that is manufacturing hundreds of products.”

The FDA’s commissioner, Dr. Margaret Hamburg, insisted the agency has limited authority over compounders such as New England Compounding, which are supposed to custom-make drugs for individual patients. But Ameridose is licensed by the FDA as a manufacturer and is clearly subject to its regulatory powers.

Hamburg told the Senate committee Thursday that she could not discuss why the agency never sent a warning letter to Ameridose because that is part of an internal investigation.

Ameridose issued a statement on Thursday night that said “the company has never received a warning letter from the FDA, a fact that does not apply to hundreds of other companies that are FDA certified manufacturers. . . . While we have been notified of some adverse events over the past six years, we are not aware of any patient issue that was shown to be the result of a problem with one of our products.”

New England Compounding, which is owned by the same families as Ameridose, is blamed for making contaminated steroids that have sickened 461 people, 32 of whom have died from a rare fungal meningitis or related complications.

Dr. Beth Bell of the federal Centers for Disease Control and Prevention told the senators that even with treatment, many of these patients are returning to the hospital with new symptoms and conditions, such as inflammation of membranes around nerves and abscesses at the original injection sites near the spine or in joints. “This suggests that there may be long-term complications for patients that have not yet become apparent,” she said.

The fact that New England Compounding, which is now closed, had been in and out of trouble with the FDA and the Massachusetts pharmacy board since 1999, and yet was allowed to continue to operate nearly unchecked, prompted this week’s hearings.

Echoing House members at their own hearing on Wednesday, senators called the Massachusetts pharmacy board “incompetent” and suggested that if it does not improve its oversight of compounders, the FDA should step in. Earlier this month, the board passed emergency regulations giving it more authority over compounders, including the ability to track the volume of drugs they are making and where they are shipping them.

Senators also said the FDA could have prevented the outbreak if not for internal confusion and “bureaucratic inertia.”

Health committee chairman Tom Harkin, a Democrat from Iowa, said the committee would move ahead with a bipartisan effort to draft legislation to give the FDA clearer authority over compounders. Committee members said larger ones that ship drugs out of state will be the focus.

David Miller, chief executive of the International Academy of Compounding Pharmacists, which has lobbied heavily against more regulation in the past, said he was committed to working with Congress “to protect the public.” But at the same time, he said in his testimony that the FDA already has clear authority to shut down manufacturers like New England Compounding that are masquerading as compounding pharmacies, leaving it uncertain if the group would back an expanded role.

The staff report detailed the repeated failure of the FDA and Massachusetts pharmacy board to aggressively rein in New England Compounding.

In 2002, five patients became ill after being injected with a New England Compounding product, and two more were hospitalized with meningitis-like symptoms. Those two had received spinal injections for pain with the same steroid implicated in the current outbreak. Yet, the state did not enter into a consent agreement with the company to improve its practices until 2006.

Finding separate problems with the sale and marketing of other drugs, the FDA issued a warning letter to the company in 2006 and a follow-up letter in 2008 telling it “to clean up its act or there would be specific consequences,” said Senator Pat Roberts, a Kansas Republican. But he said there was no follow-up by the agency.

“I wish the responses had been more timely and there had been better communication with the state and the outcomes had been different,” Hamburg said.


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