Meningitis gets attention.
As a result of the national outbreak linked to a Massachusetts compounding pharmacy that has so far killed 32 people and sickened about 500 others, the FDA has petitioned Congress for more authority over compounding facilities.
According to a recent article in the Burrill Report, the FDA conducted three inspections of the New England Compounding Center (NECC) in the years 2002 through 2006 and “issued two official violation reports and one warning letter in 2006, according to information the FDA provided during the hearing before the House Energy and Commerce Committee.”
Time to Act
However, it appears the FDA responded with a lack of urgency: Tim McLaughlin with Reuters indicated the agency “took 684 days to issue a warning letter after uncovering infractions that could potentially harm patients at the pharmacy.”
NECC seized on this as indication the FDA perceived the risks at its operation as minimal.
“We believe that FDA’s nearly two-year delay in issuing the warning letter contradicts FDA’s rhetoric regarding the asserted risks associated with our compounded products,” states NECC co-owner and chief pharmacist Barry Cadden.
The FDA countered that the warning letter delay was a result of the agency’s limited, unclear, and contested authority. A big issue is that most compounding companies are regulated by state pharmacy boards, whereas manufacturers are regulated by the FDA. At what point does a compounder become a manufacturer? The distinction between the two has been blurred by court cases that have overturned FDA actions in the past.
As a result, “during the time between the inspection of NECC and the issuance of the warning letter, there was ongoing litigation pertaining to pharmacy compounding and significant internal discussion about how to regulate compounders, all of which delayed FDA,” states FDA spokesperson Erica Jefferson.
In response, the FDA has asked for more authority to oversee large-scale drug compounders such as NECC and make them meet basic safety standards. “There is an enormous lack of clarity and we should seize this opportunity to address it,” says FDA commissioner Margaret Hamburg.
Several Republicans countered that the FDA already has sufficient authority and could have done more to prevent the outbreak. A congressional panel has also requested additional documents from the FDA regarding its history of interaction with NECC.
Regulating a Growing Segment
Large-scale pharmacy compounding has expanded greatly over the last decade, in part because drugs from compounders can be lower cost due to their lower regulatory overhead.
Hamburg called for a tiered approach to regulating compounding pharmacies, separating them into “traditional” and “nontraditional” categories.
“Traditional compounders, who generally operate under the one-prescription-one-drug paradigm, will still be under the oversight of state boards of pharmacies,” wrote David Pittman at MedPage Today. “Nontraditional compounders would register with the FDA and adhere to other requirements typically mandated for manufacturers.
This approach makes some pharmacy trade associations uneasy.
“When we start with these tiers and these additional hybrids, I am very concerned,” comments David Miller, chief executive of the International Academy of Compounding Pharmacists. “The more complex we make this and the more we get into the shuffle between who is accountable [the harder it will be] to resolve this problem. Either you are a pharmacy or you are a manufacturer.”
The FDA stated that Congress exempted compounders from the 1997 FDA Modernization Act and efforts to regulate them have been blocked in federal circuit courts.
“Sen. Pat Roberts (R-Kan.) took particular interest in the hearing, having supported an amendment to the 1997 FDA Modernization Act that would have allowed the FDA a closer look at regulated compounded pharmacies,” says Pittman. “That language was stripped from a final bill.”
Roberts offers the following suggestions for regulating compounders:
- Ensure states properly oversee compounding pharmacies
- Make sure schools train compounders correctly
- Implement criteria to determine whether companies should be regulated by states or by the FDA
- Require adverse-event reporting for compounding pharmacies
- Label compounded products appropriately
“Protecting Americans from unsafe and contaminated drugs is not just an important responsibility of FDA—it is part of our core mission,” said Hamburg. “Requiring non-traditional compounders to report adverse events, as drug manufacturers are required to do, would allow FDA and the states to identify trends and to proactively take steps to curtail dangerous compounding practices.”