US Food and Drug Administration (FDA) officials yesterday confirmed what they have feared for more than a week: Products from yet another pharmaceutical compounding pharmacy are contaminated with fungal and bacterial growth.
Compounding pharmacies have been subject to enhanced scrutiny by FDA in recent months, resulting in a huge number of Warning Letters, Form 483s, recalls and general warnings to consumers and healthcare providers.
The root of this enhanced scrutiny can be traced back to a series of incidents first identified in late 2012 involving a Massachusetts-based company known as the New England Compounding Center (NECC), whose products were associated with a massive outbreak of fungal meningitis. A subsequent investigation by FDA and state regulators would determine that the practices that led to the outbreak were part of a troubling pattern seen across the entire industry, and pressure from legislators prompted regulators to initiate an intensive series of inspections.
Most of the problems since identified by FDA have to do with sterility concerns, either with the processes used to manufacture a product or with the product itself. For example, in March 2013 two compounding pharmacies initiated recalls of their products after being unable to assure the sterility of their respective products.
Neither, however, were associated with any adverse events, and the companies were quick to note that the recall was being done out of an abundance of caution.
Public health officials, including FDA and the Centers for Disease Control and Prevention (CDC), have since been on the lookout for other cases of contamination, wary of the potential for even a single compounding pharmacy's products to affect the health of those around the country.
In late May 2013, their vigilance paid off, with FDA announcing that products compounded by Main Street Pharmacy of Newbern, TN had been linked to at least seven adverse events, including at least one fungal infection.
As Regulatory Focus pointed out at the time, the case presented numerous parallels to the NECC case, with both products being compounded (supposedly) sterile injections of methylprednisolone acetate. At the time, FDA said its investigation into the contamination was "ongoing," but urged practitioners to quarantine all products out of an abundance of caution. Main Street Pharmacy announced it would initiate a voluntary recall of all products on 28 May 2013.
FDA's 7 June 2013 update on its testing confirms the agency's initial suspicions regarding contamination. In a statement, FDA said it has positively identified both bacterial and fungal growth in samples of two unopened vials of the steroid injections, though it was still working to confirm the exact species of fungus.
Regulators may be breathing a certain sigh of relief, though, as no fatalities have yet been associated with the company's products. Adverse events so far include skin and soft tissue abscesses, but no cases of fungal meningitis-the hallmark of the NECC contamination that left dozens dead and hundreds more seriously ill.
More fortuitous still might be the case's effect in Congress. Both Houses of Congress have been considering new legislation to place limits on the authority of FDA to regulate compounding pharmacies, but the legislation has since stalled in the House, where skeptical legislators seemingly aren't convinced that FDA actually needs more authority to regulate compounding pharmacies. The case could give FDA additional ammunition to convince legislators that the case isn't going away, but legislators might also highlight the case as being an example of FDA making due with the authority it already has.
For now, FDA says its investigation is ongoing, with researchers still attempting to determine which strains of bacteria and fungus have infected Main Street Pharmacy's products.