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.
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 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 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 recall all 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.
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."
A Recall Requested-and Denied
But despite FDA requesting the company recall its products-a recall FDA notes would be classified as a Class I recall, its most serious classification-the company has reportedly refused that request, according to a new statement released by FDA.
"NuVision Pharmacy has repeatedly declined to recall its sterile products," FDA wrote, adding that under federal law, the agency "cannot require NuVision to undertake such a recall."
The problem is likely the agency's differing authority with respect to traditional pharmaceutical manufacturers and compounding manufacturers. While FDA possesses the authority to demand recalls from the former, it lacks the same authority over the latter.
Legislative fixes intended to remedy the discrepancy have been slow in the making. Despite taking up legislation in October 2012 after a compounding pharmacy's products were linked to a massive outbreak of fungal meningitis, Congress has yet to settle on a mutually agreeable set of fixes, leaving FDA to explore and press the limits of its authority.
And in the case of NuVision, the limits of that authority are now clear, leaving FDA to try a new tactic: Public shaming.
"The agency reminds health care providers not to use any sterile products from NuVision," FDA wrote in the 16 August 2013 announcement.
FDA did note, however, that it is not aware of adverse events associated with any non-recalled products.
FDA Announcement on NuVision