Safety recalls are regularly conducted in the healthcare products sector, falling along a three-tiered classification system in which the most serious recalls are referred to as "Class 1" recalls. But despite healthcare professionals often seeing the end result of these recalls-a notice, and usually a "voluntary" recall, as opposed to an agency-ordered one-they rarely get a glimpse into how that recall is ordered.
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 second notice posted by FDA was through its MedWatch adverse event reporting program, which recommended that healthcare 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 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."
An Unusual Letter
The episode had mostly faded into the background since then, with FDA releasing no other information until 6 August 2013, when in response to a Freedom of Information (FOIA) request, FDA revealed that the company's failure to recall its products has not been for lack of trying, providing an inside look into how the agency cracks down on companies whose opinions differ from its own.
A letter posted to FDA's website, 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.
In the case of NuVision, FDA said its concerns were no longer hypothetical, noting that the company has already received adverse event reports of patients with flu-like symptoms, fever and injection site soreness.
In addition, FDA's letter says that the agency has found the company's products to be adulterated under the Federal Food, Drug and Cosmetic Act (FD&C Act), Section501(a)(2)(A), and noted that NuVision had been found to be producing products without first obtaining a valid prescription, a violation of federal law.
"FDA has determined that due to the lack of sterility assurance of NuVision sterile products, the sterile drugs distributed by NuVision present a risk of illness or injury to consumers," the agency continued. "To date, NuVision has not initiated a recall of all of its sterile products that are within expiry. FDA action is therefore necessary to protect the public health and welfare."
Recall your Products-or Else
As a result, FDA said it was ordering an uncommon agency-initiated Class 1 recall, and is requesting the company's close cooperation to conduct the recall in a "timely manner."
Another press release on the recall will be forthcoming from FDA, the letter adds.
"Failure to comply with this request can result in further regulatory action being taken against you, your firm, and the adulterated products distributed by your firm," FDA concludes.
The letter, signed by Plaiser, also shows evidence of review by Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) and Douglas Throckmorton, CDER deputy director of regulatory programs.
FDA Letter to NuVision