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FDA ponders new pharmacy rules after deadly outbreak

Cj Gunther / EPA

A Food and Drug Administration agent enters the offices of New England Compounding Center in Framingham, Mass. on Oct. 16. The FDA has proposed a new way to regulate pharmacies responsible for a deadly outbreak that has killed 39 people.

The Food and Drug Administration is recommending a new way to regulate so-called compounding pharmacies after an outbreak of fungal meningitis that has infected 620 people and killed 39 of them.

The FDA recommends dividing these pharmacies into two categories: typical compounding pharmacies, which make medicines to order based on individual prescriptions, and high-output pharmacies that would be regulated differently. A consumer group says this is a recipe for disaster.

The outbreak, first confirmed in September, has been traced to the New England Compounding Center in Framingham, Mass. It was licensed as a compounding pharmacy, which means it was supposed to mix and distribute drugs only on an individual, prescription-by-prescription basis.

However, investigations have shown NECC worked on a much, much larger scale, and somehow wiggled out of several run-ins with both the FDA and state regulators over the scale of its operation and also previous cases of contamination.

FDA investigators have found vials of steroids used for back and joint pain injections were contaminated with at least two species of fungus, as well as bacteria. Patients being treated for back pain had these contaminated drugs injected right into their spines, where the fungus grew slowly, eventually spreading into spinal fluid and causing vague symptoms such as headache and fever.

So far, 33 of the victims have had strokes, and patients all face weeks and months of therapy with strong antifungal drugs that themselves can have severe side effects, the Centers for Disease Control and Prevention says.

FDA officials are holding a meeting later on Wednesday with representative of states to discuss how to better regulate pharmacies, especially since more and more super-compounders like NECC are operating.

“A category of ‘nontraditional’compounding has evolved in the last decade that FDA believes requires additional oversight. The Agency is working with Congress to consider new authorities regarding ‘non-traditional’ compounding pharmacies,” the  FDA said in a statement issued ahead of the meeting.

“Historically, regulation of pharmacy compounding has focused on drawing a line between traditional pharmacy compounding and other manufacturing.” States have regulated the small compounding pharmacies, while FDA has regulated the big manufacturers.

“Going forward, FDA believes the focus should be shifted from attempting to draw a bright line between traditional pharmacy compounding and other manufacturing to clearly defining traditional pharmacy compounding that should be primarily overseen by the states and higher risk non-traditional pharmacy compounding that would require compliance with federal standards,” the FDA says.

The consumer group Public Citizen says the FDA is trying to give up some of its responsibility for regulating pharmacies.

“The FDA’s proposal for oversight of ‘non-traditional’ compounding, if implemented, would decriminalize what is now illegal drug manufacturing conducted under the guise of pharmacy compounding, and ensure the continuing occurrence of serious disease outbreaks caused by tainted drugs in the future,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “The proposal would legitimize current abuses to the system and put the public at risk.”

Carome suspects Hamburg wants to pass much of its responsibility for regulating even the big compounders to the states. And, he says, many of the drugs that would be made by the new class of compounding pharmacies would be sterile drugs meant to be injected. “This is a high-risk class of drugs, no matter how many doses you make” Carome said in a telephone interview.

Carome’s group wrote a letter to Health and Human Services Secretary Kathleen Sebelius urging her to reject any such proposal.

“We have expressed concern all along, since the fungal meningitis outbreak became known, that this represents a significant regulatory failure on the part of the FDA, that at the highest levels the agency sought to dodge criticism,” Carome said in a telephone interview.

“There needs to be an independent investigation of this.” Carome suggests the Office of Inspector General could undertake such an investigation.

Neither the FDA nor officials with the department of Health and Human Services have responded to questions about Public Citizen's concerns. 

Carome’s not alone in accusing the FDA of of dodging questions. Several senators and representatives, even some Democrats friendly to the administration, accused FDA Commissioner Dr. Margaret Hamburg of avoiding giving straight answers to their questions at hearings in November.

"This is a complete and utter failure on the part of your agency," Rep. Cliff Stearns, the Florida Republican who chairs the House Energy and Commerce oversight subcommittee, told Hamburg at a Nov. 14 hearing.

Hamburg told Congress the FDA needs stronger authority to regulate the pharmacies. Congress passed a bill in 1999 that would do that, but part of it was thrown out by the Supreme Court and Congress and the FDA never decided how to proceed.

“Under current law, FDA can act and needs to act. They can’t wait for new legislation,” Carome contends. But he also supports a bill offered by Connecticut Democratic Rep. Rosa DeLauro that would strengthen FDA’s authority.

Republicans who control the House say they aren’t sure the FDA needs any more powers, and it’s not clear if or when Congress could come up with a bill.

And FDA has noted that compounding pharmacies play an important role in filling needs during drug shortages.

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