It’s been several months since compounding pharmacies in New England came under severe scrutiny by health officials, following a fatal outbreak of fungal meningitis that affected patients nationwide.
Our Alabama pharmaceutical litigation attorneys predicted that, given the lack of oversight, such hazards were sure to repeat. Sure enough, they have – this time at a Texas compounding facility called NuVision Pharmacy.
The U.S. Food and Drug Administration has issued a second warning regarding the facility’s supposedly sterile products, which the company has refused to recall, despite the FDA’s mandate. The first warning about the company’s products was issued back in mid-May.
The FDA issued another recall request letter in late July, citing poor sterile production practices that were spotted by FDA investigators during an inspection in April. The agency said that if a drug was marketed as sterile, yet contained any trace of microbial contamination, patients would be at high risk for a serious and potentially even life-threatening infection.
For its part, the compounding facility insists it is committed to protecting patient well-being. As a non-manufacturing entity, administrators insist they are in compliance with standards of law outlined for compounding pharmacies, and that the FDA inspectors were using regular manufacturing-industry standards when evaluating its facilities.
But perhaps this is the problem.
Compounding pharmacies, if you are unfamiliar, are those in charge of creating specialized pharmaceutical products to fit the unique needs of certain patients. For example, there may be a need for one patient to have a liquid form of a drug instead of a pill form. A compounding pharmacy could make it happen. Or perhaps there is a non-essential element in the medicine to which certain patients are allergic. A compounding pharmacy could be tapped to produce a form of the drug without that ingredient.
These companies are not supposed to be mass producers of these products, but they often do it anyway.
A 50-page Government Accountability Office report, issued in late July, revealed that the authority of FDA to oversee drug compounding pharmacies is unclear. Two federal circuit court decisions have resulted in differing authority standards in different parts of the country. The FDA contents this has limited its inspection authority and has hampered its enforcement efforts – which it did attempt to significantly beef up following the recent fatal outbreak that sickened nearly 750 people and killed more than 60.
For example, FDA officials reported that prior to a dozen recent inspections, the agency first had to obtain a warrant before entering the property. This eliminates the element of surprise, meaning that compounding pharmacies would have the opportunity to clean up any possible violation well in advance of the inspector’s arrival.
In this most recent case, FDA officials say at least two patients who received hospital injections of the Texas compounding agency’s drugs developed bacterial bloodstream infections. It is believed they were caused by the injections. More cases could exist, but have not yet been reported.
FDA reissues alert after compounding pharmacy refuses recall request, Aug. 16, 2013, By Tom Wilemon, The Tennessean