Regulatory Focus™ > News Articles > Unfair Balance and Unsubstantiated Claims Prompt Untitled Letter to Pharmaceutical Manufacturer

Unfair Balance and Unsubstantiated Claims Prompt Untitled Letter to Pharmaceutical Manufacturer

Posted 05 June 2013 | By Alexander Gaffney, RAC

An Untitled Letter sent by the US Food and Drug Administration (FDA) in May 2013 calls out Sigma-tau Pharmaceuticals for allegedly marketing its chemotherapy drug Oncaspar (pegaspargase) using a "false or misleading" sales aid that regulators said made unsubstantiated claims and minimized safety information.

Basic Information

FDA's letter is perhaps more problematic than most in that an agency regulator discovered the potential infraction-a sales aid-at the company's promotional exhibit booth at a chemotherapy conference, and not by reviewing materials submitted by the company to the agency (a process by which most other infractions are found).

The basic of the Untitled Letter is that Oncaspar, a component of a multi-agent chemotherapeutic regimen for acute Lymphoblastic leukemia (ALL) as well as those with ALL and hypersensitivity to native forms of L-asparaginase, was marketed incorrectly in four separate ways:

  • unsubstantiated superiority claims
  • minimized risk information
  • other unsubstantiated claims
  • material facts were omitted from the promotion

For example, FDA said the company indicated that Oncaspar would allow patients to unlock the "full benefits" of Asparaginase therapy-a claim FDA said implied that other treatments would not permit patients to fully benefit from the therapy, a claim that was not substantiated in any trial known to FDA. Further in the letter, FDA said Sigma-tau claimed its drug allowed for "greater flexibility" and "fewer patient visits," though this too was unsupported by "substantial evidence" since the cited study failed to consider "all of the relevant patient visit scenarios."

Fair Balance

Elsewhere, FDA noted that the promotional material did not present its efficacy data and safety data using the same methods. For example, efficacy data was presented with "large bolded headlines and colorful graphics" during the first seven pages of the 10-page guide. Contrast that with the safety data, which started on page eight and saved the most important information until page 10.

"In contrast to the large type, ample white space, and colorful efficacy presentations contained in the first nine pages, this risk disclosure on the back page is presented in black font type and single-spaced bullets," FDA wrote. "As such, the piece fails to present risk information with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug."

Minimized Risk

Meanwhile, other safety claims were minimized in several ways and three claims were found to lack substantiation in the promotional materials, regulators said. Finally, FDA flagged a statement that the drug had "no age restrictions," which it said omitted the fact that those aged 65 and older were not studied in sufficient numbers to determine whether their response was similar to younger patients. While the company included a disclaimer about this fact, it was only included on the back cover of the pamphlet.

FDA said that Sigma-tau should "immediately cease the dissemination" of the promotional sales guide and others containing similar materials (should they exist).

An Untitled Letter is less serious than a Warning Letter in that it does not threaten enforcement action against a company, but merely alerts it to a problem. They are most often used to convey the agency's thoughts regarding marketing materials.

FDA: Untitled Letter to Sigma-Tau

The Promotional Material

Regulatory Focus newsletters

All the biggest regulatory news and happenings.