FDA meets with state pharmacy leaders to develop new rules for compounders

By Deborah Kotz and Kay Lazar

 |  GLOBE STAFF   

  DECEMBER 20, 2012

SILVER SPRING, Md. — US Food and Drug Administration officials met in an open forum with state health representatives Wednesday to come up with a framework for new federal laws that would tighten oversight of compounding pharmacies such as the Massachusetts company blamed for the national fungal meningitis outbreak.

The FDA regulates drug manufacturers but not compounders, which typically custom make medicines for individual patients, such as those who cannot take standard versions of drugs. Regulators say New England Compounding Center in Framingham produced medications in bulk and distributed drugs nationwide, much like a manufacturer, in ­violation of its state license.

“This case with NECC clearly shined a very harsh spotlight on the fact that compounding pharmacy entities need a more comprehensive, consistent, and strong regulatory system,” Dr. Margaret Hamburg, the FDA commissioner, said during a press briefing. “How can we move to ensure that this kind of event doesn’t happen again?”

Batches of steroid injections produced by New England Compounding became contaminated with a fungus and were injected into roughly 14,000 ­patients, resulting in 39 deaths and 620 cases of meningitis across 19 states this past summer and fall.

In an article published online by the New England Journal of Medicine Wednesday, the Centers for Disease Control and Prevention concluded that about 4 percent of the 14,000 patients exposed to the contaminated steroids have become sick so far.

But that rate varies significantly by state and the batch of steroid used, the article said. In Michigan and Tennessee, about 11 percent of exposed patients got sick, for reasons that are ­unclear. And patients who got injections from a lot of methylprednisolone acetate made in June were more likely to get sick than patients who received injections from two other contaminated lots.

In testimony to Congress last month, Hamburg proposed establishing new laws for “non-traditional compounding” that poses higher risks for patients such as when a product is made in multiple batches or shipped out of state, as in the case with New England Compounding.

But Hamburg pointed out that creating standard definitions to distinguish traditional compounding — where a pharmacy mixes a single medication for an individual patient — from other types of compounding has proven to be a challenge for states. For example, the FDA would like to institute tougher federal oversight of what Hamburg called “hybrid manufacturers,” which may mix a dozen doses at a time to be shipped to various hospitals, while still keeping it illegal to have large-scale manufacturing of compounded drugs.

While the FDA must rely on Congress to pass new laws granting it stronger authority over compounding pharmacies, Hamburg said she was “guardedly optimistic” that some form of legislation would be passed when a new Congress convenes next year.

House Energy and Commerce Committee chairman Fred Upton, Republican of Michigan, released a statement criticizing the FDA for its “lack of urgency” in producing internal communications and documents related to New England Compounding that would identify why the pharmacy’s procedures had fallen through regulatory cracks.

“The sooner the FDA cooperates,” Upton said, “the sooner we can determine what went wrong and take steps to help ensure we never again endure a deadly outbreak like this one.”

States also need to determine what resources they need to ensure that they will be in compliance with any new federal regulations.

“In our [New England] region, there was a significant level of consensus on a lot of ­issues including the need for improved communication among states and the FDA and improved training and support for state boards of pharmacy, particularly on issues related to sterile compounding,” Dr. ­Lauren Smith, interim Massachusetts health commissioner, said in an interview after the meeting. Sterile compounding involves making products for injections or infusions.

Health leaders from across the country told FDA officials that better communication is sorely needed between federal and state regulators so that all are informed when sanctions are imposed against a pharmacy.

“We feel great about what we are doing in our state, but, gosh, we don’t know what those other guys are doing,” said Jay Campbell, executive director of the North Carolina Board of Pharmacy.

Health leaders also ­expressed frustration over the lack of a central database for regulators to check disciplinary actions taken against pharmacies in other states. There is such a database for regulators to check pharmacists.