Regulatory Focus™ > News Articles > FDA Calls out Pharma Company for Repeated 'Violative' Marketing Practices

FDA Calls out Pharma Company for Repeated 'Violative' Marketing Practices

Posted 25 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released a warning letter sent to Octapharma USA, Inc on 10 April 2012, in which the agency scolds the company for numerous marketing violations.

FDA's Advertising and Promotional Labeling Branch (APLB), located within the Center for Biologics Research and Evaluation, reviewed some of Octapharma's advertisements within two publications released in December 2011.

FDA rapped Octapharma for "false and misleading" advertisements after the company allegedly omitted risk information and "failed to submit promotional materials to CBER at the time of initial dissemination."

FDA noted this is not the first time the company has been found to have been in violation of regulations by the agency.

"We are concerned by your continued violative promotion of your products" explained FDA in its warning letter, which was released to the public 23 April. "Octapharma was cited for similar violations (including failure to reveal material facts and failure to submit promotional materials to the FDA) in a Warning Letter on August 31, 2005… [and] in a teleconference on October 13, 2009."

"The journal advertisements […] fail to provide any information pertaining to the potential risk of acute renal dysfunction and renal failure with the use of [Octapharma's product] Octagam," continued FDA. "Furthermore, they fail to contain any important safety information, including the boxed warning, contraindications, warning and precautions, and adverse reactions."

FDA said it is calling on Octapharma to stop disseminating "violative promotional materials" such as those described in the warning letter, and also called on the company to respond in writing indicating what steps it would be taking to cease future violative acts given the company's history with FDA.

Read more:

FDA - Octapharma USA, Inc. 4/10/12


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