An Untitled Letter sent to Spectrum Pharmaceuticals by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) cited an advertisement used to market the company's non-Hodkin's lymphoma drug Zevalin, which regulators claim over-states the drug's efficacy.
Background
Per FDA regulations, all advertisements for approved pharmaceuticals must meet certain basic standards, among them an appropriate and accurate representation of the drug's risks and benefits, both balanced in equal measure against one another.
OPDP routinely sends out Untitled and Warning Letters to companies that fail to ensure the accuracy of their advertisements, particularly when those claims are published in lengthy sales aids intended to be read by prescribing professionals with responsibility for a patient's well-being.
And if there's one thing that comes across in these Untitled Letters, it's that OPDP reads these sales aids closely-very, very closely.
Improper Support of Claims
And a close reading of Spectrum Pharmaceutical's sales aid turned out to be bad news for the company, according to the Untitled Letter, which was posted to FDA's website on 31 July 2013.
OPDP said it took issue with the company's claim that Zevalin "delivers radiation precisely where it's needed" and that the product "specifically targets" an antigen found in most B-cell lymphomas. Those claims were based off a Phase I/II study that was not intended to determine either claim, and accordingly did not meet FDA's standards of evidence.
In addition, the company wrote in the sales aid that side effects can be "predictable and manageable," a claim FDA said minimizes the "serious risks" associated with the product's use.
Other parts of the same sales aid reportedly had the effect of over-stating the product's efficacy, noting that use of the drug was tied to "improved overall survival" and "improved long-term survival." OPDP said the precise wording of both claims were not supported by data reviewed by agency regulators. Similar violations were noted in six other claims, FDA added.
A History of Problems
Unfortunately for Spectrum, OPDP said it had reason to read the company's materials more closely, having already sent "advisory comments" to the company in 2003, 2004 (twice), 2006 and 2009, with several of these letters speaking to alleged mischaracterizations of the respective product's mechanism of action and associated risks.
FDA said it had requested that Spectrum cease marketing Zevalin using the cited material and to submit a written response by 6 August 2013.
Untitled Letter to Spectrum
Sales Aid