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Montero backs FDA oversight of compounding pharmacies

New Hampshire Union Leader

November 17. 2012 11:31PM

The state's public health director says he supports the call this week from the head of the U.S. Food and Drug Administration for federal regulation of compounding pharmacies that use legal loopholes to operate as drug manufacturers without federal oversight.

"When you are doing things that are mass-produced, you are manufacturing and maybe that's where we need clear and strong federal regulation and oversight," Dr. Jose Montero said.

Dr. Margaret Hamburg, acting FDA administrator, told the House Energy and Commerce Committee this week that the agency needs new laws to properly police the compounding pharmacies. But some committee Republicans suggested that the FDA could have better used power it already has.

A Massachusetts compounding pharmacy made the doses of an injectable steroid blamed for a multi-state outbreak of fungal meningitis; 480 cases have been linked to the outbreak so far nationwide. New Hampshire has 13 cases to date: nine cases of suspected meningitis and four joint infections traced to the tainted medicine.

There have been 32 deaths in 19 states, but none in New Hampshire.

The steroid was given to alleviate back and joint pain.

Compounding pharmacies mix various ingredients into prescription drugs. Many states regulate the practice as they would a drug store, requiring specific prescriptions for a specific patient for every compounded product produced.

But the New England Compounding Pharmacy of Framingham, Mass., the company that produced the injectable steroid blamed for the meningitis outbreak, has been accused by Massachusetts officials of going beyond its state license by manufacturing and selling drugs in bulk without regard to whether there were prescriptions for every dose.

Montero says the New Hampshire Board of Pharmacy can stay on top of compounding pharmacies that fill individual prescriptions, but when the operation grows into making batches of drugs for distribution, it's another story.

"The question is if someone sets up shop here in New Hampshire, do we have the skills here to do the inspection to guarantee safety for everybody," Montero said. "That's the role clearly of the federal government."

Some compounding pharmacies operate in a regulatory shadow, using a license granted to mix up prescriptions for particular patients to effectively become drug manufacturers.

But unlike well-known pharmaceutical companies, the compounders come under no federal oversight, and are subject to varying degrees of regulation depending on their home states. According to Montero, there is no permanent structure to share state regulatory findings.

The only authority New Hampshire had over NECC was to license the company as a mail-order pharmacy and trust the pharmacy board in Massachusetts to do its job.

But that board fired its executive director and removed one of its attorneys for failing to act on repeated complaints about unsanitary conditions at the NECC factory. Massachusetts officials have admitted that state inspectors did nothing as NECC shipped thousands of doses of medicine without the individual prescription required by the state's laws.

State public health directors from around the country met by teleconference to discuss keeping each other informed about regulatory issues concerning compounded drugs.

Wary of ceding too much state authority to a federal agency, Montero is encouraged by the FDA's willingness to work with state officials on closing loopholes.

"You need to be careful of how you regulate, have to be mindful of the impact of regulations but also protect the patients," Montero said. "It's great that the federal government is willing to work with state health directors."

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