FDA, states study regulation of compounding pharmacies

Commissioner calls for bill to clarify how entities like New England Compounding should be regulated

3:42 AM, Dec 20, 2012
SILVER SPRING, MD. — The U.S. Food and Drug Administration met with representatives of all 50 states Wednesday to examine bridging gaps in the regulation of compounding pharmacies in hopes of preventing a recurrence of the type of contaminated drug shipments this fall that caused widespread sickness and deaths.

“We do strongly believe we need additional legislation,” FDA Commissioner Margaret Hamburg said, adding she is “guardedly optimistic” the 113th Congress, which begins meeting in January, will approve a bill that will clarify exactly how entities like the New England Compounding Center of Framingham, Mass., should be regulated.

The NECC was the source of mass-produced steroid injections that led to 620 cases of fungal meningitis in 19 states this fall, resulting in 39 deaths. With 14 deaths, Tennessee has had more than any other state.

Hamburg emphasized that the FDA is not yet ready to release any findings regarding its investigation of NECC.

While states remain confident in their ability to regulate compounding within their own borders, they have concerns about compounding done in other areas and shipped in interstate commerce, Hamburg added.

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

The importance of Wednesday’s gathering was providing a “whole new platform” for finding ways for the states and FDA to better cooperate in regulating compounders to prevent another NECC, said John Kirtley, executive director of the Arkansas State Board of Pharmacy.

Key questions on which Hamburg and other agency officials solicited input included:

• Whether states can adequately protect consumers through their oversight of compounding pharmacies.

• What oversight the federal government should exercise over large-volume compounders that ship across state lines.

• The need to “rebalance” federal and state regulation of compounding to better protect public health.

• The role for states in enforcing federal standards regarding large-volume compounding.

Those at the meeting, held at the FDA’s Washington-area headquarters, included representatives of governors’ offices, state pharmacy boards and state departments of health.

While many, including some in Congress, have argued that preventing another NECC is simply a matter of clarifying the FDA’s authority to regulate large-scale shipments of compounded drugs across state lines, Kirtley said it’s not so simple.

Not even the FDA, he said, is going to have enough “traffic cops” to keep up with which entities are involved in large-scale compounding one month only to have compounders in other states take over their role the next.

As soon as alarms were sounded about NECC, he said, compounders in other places started filling orders from hospitals and other health systems for the same products.

“It changes constantly,” the Arkansas official said, in arguing why states will continue to have a key role.

Improving two-way communications between state pharmacy regulators and the FDA was a major emphasis throughout the daylong meetings, including making sure all inspectors at both levels promptly report relevant information to common databases and websites.

“The back-and-forth flow is key,” Hamburg said.

Legal questions

The discussions often ventured into legal questions as well, such as how states could incorporate anticipated tougher federal standards for compounders into their own regulatory methods.

At a minimum, some suggested, states could at least make failure to comply with federal standards grounds for licensing decisions.

While the FDA envisions a “tiered approach” to regulating compounders in the future that involves the states and federal government, questions of exactly where jurisdictional lines will be drawn remain central to developing legislation for Congress to consider in 2013, Hamburg said.

While many legal experts and members of Congress argue the FDA already has sufficient authority over all forms of compounding under 1938 food and drug legislation, the federal agency has always left “traditional compounding” — drug mixing done by neighborhood pharmacies — to the states. Such compounding involves single prescriptions for individual patients.

Over the past two decades, concerns have grown about nontraditional compounders that mix large volumes of customized drugs for shipment to other states. While 1998 legislation supposedly strengthened the agency’s authority over such compounders, federal court cases in different parts of the country over the past decade have led to ambiguity over the agency’s authority.

Republican Sen. Lamar Alexander of Tennessee has called it a matter of making clear “whose flag is on the flagpole” when it comes to NECC-type operations.

But Hamburg, while urging Congress to clarify “gray areas” in pharmacy regulation, insisted again Wednesday that “states are obviously on the front line.”

Contact Paul C. Barton at pbarton@gannett.com.





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