MUST READ!! With Recall Options Limited in Compounding Case, FDA Turns to Public Shaming to Protect Consumers Latest News | Posted: 19 August 2013

If you wish to see the limits of the US Food and Drug Administration's (FDA) recall authority, look no further than its attempts to recall products from a Texas-based compounding facility whose products were thought to be compromised by sterility concerns.

Background

On 18 May 2013, FDA issued two notices regarding products manufactured at NuVision Pharmacy, a Dallas, Texas-based compounding pharmacy. The first was a press statement announcing that products compounded by the company had a "lack of sterility assurance," as evidenced in a recent inspection of the company's Dallas facility.

"FDA investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company’s sterile drug products," the agency wrote. A subsequently released Form FDA 483 showed an extensive lack of monitoring, documentation, testing or other good manufacturing practices (GMPs).

A second notice posted by FDA was through its MedWatch adverse event reporting program, which recommended thathealthcare providers stop using the products immediately and quarantine all remaining supplies.

Notably—and unusually—despite NuVision issuing a limited recall in April 2013 due to similar issues, the company didn't issue a recall notice for all of its products, presumably because of one fact acknowledged by FDA: "The agency is not aware of any additional adverse event reports associated with other sterile products other than those recalled in April from NuVision."

Attempts to Pressure a Recall

That limited recall resulted in FDA sending—and publicly releasing—a letter to NuVision requesting the company recallall of its products, providing a rare glimpse into how the agency cracks down on companies whose opinions differ from its own.

The letter, dated 26 July 2013, details an attempt by Melinda Plaisier, acting associate commissioner for Regulatory Affairs, to get the company to recall its products.

The "FDA Requested Recall" letter explains that it has been sent because of "poor sterile production practices" found during the agency's most recent inspection of the Dallas facility, which could result in "life-threatening" consequences for patients. Similar sterility issues at a Massachusetts-based compounding pharmacy in late 2012, for example, were implicated in the deaths of dozens of patients across the US.

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