The FDA and health officials from all 50 states came together Wednesday for a one-day workshop to help identify and close the gaps in overseeing compounding pharmacies including the ones like the Massachusetts one linked to 39 deaths from fungal meningitis.
Heads of state boards of pharmacy – who oversee compounding pharmacies – told the FDA they need better communication with the federal agency and greater clarity in certain areas to understand what aspects they’re responsible for and what the FDA controls.
In the nearly 3 months since the outbreak started, the FDA has claimed gaps in regulating compounding pharmacies helped facilitate lax oversight of Framingham, Mass.-based New England Compound Pharmacy (NECC), found to have shipped tainted steroids that later infected more than 600 patients in 19 states.
As the field of compounding pharmacy grows, the “gray area” between compounding and manufacturing, which is regulated by the FDA, and circumstances such as the NECC arise where a compounder acts like a small manufacturer with little oversight.
“Our concern is that if we don’t act explicitly it will continue to be in that gray area without adequate oversight,” FDA Commissioner Margaret Hamburg, MD, told reporters Wednesday.
Hamburg said states have different laws, resources, and priorities and greater understanding is needed to help improve the oversight of compounding
Heads of state boards of pharmacies stopped short of a call for federal legislation, but they were frank about their need for federal help in a number of areas, including creating a better definition of the compounding pharmacy label, as well as clear distinctions between compounding and manufacturing.
Communication is also a problem as the states and the FDA both pointed to problems sharing inspection data.
“If you gather information that we need, you need to share it,” Jay Campbell, JD, executive director of the North Carolina Board of Pharmacy, said Wednesday. “If we gather information that you need, we need to share it.”
Campbell said there needs to be better communication on poor pharmacies among states. While that’s easily done with pharmacists, the industry is working on a similar system for pharmacies.
“We know what happens in our pharmacies,” John Kirtley, PharmD, executive director of the Arkansas State Board of Pharmacy, said. “We don’t necessarily know what’s going on in specific pharmacies in specific states that ship to us.”
Hamburg said the work done Wednesday will help “make an enduring difference” in bettering the oversight of compounding pharmacies.
And she reiterated her call to Congress to give the FDA greater clarity in its oversight of compounding pharmacies. The commissioner said that authority is unclear and contested.
“We have to be very explicit about who is responsible where,” Hamburg said Wednesday.
The FDA supports creating a “traditional” and “nontraditional” classes of compounders to better clarify who acts under state authority and who under federal oversight.
That approach was rejected out-of-hand by the consumer watchdog Public Citizen in a letter to the Department of Health and Human Services.
“The FDA’s proposal for oversight of ‘nontraditional’ 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,” Michael Carome, MD, deputy director of Public Citizen’s Health Research Group, said.
In testimony last month before the House Energy and Commerce Committee, Republican lawmakers were critical of the FDA commissioner and said the FDA already had the authority and just failed to take action.
Nonetheless, Hamburg said she was “guardedly optimistic” Congress would take action on its requests.