Regulatory Focus™ > News Articles > Citing Confidentiality Troubles, Mystery Firm Petitions FDA to Delay Posting of Warning Letter

Citing Confidentiality Troubles, Mystery Firm Petitions FDA to Delay Posting of Warning Letter

Posted 11 April 2013 | By Alexander Gaffney, RAC 

The story has it all: Mystery, intrigue, failures and secrecy. But it's not the latest plot line for a mystery novel-it's the latest out of the US Food and Drug Administration's (FDA) federal register docket, where a prominent life sciences law firm has petitioned the agency to hold off on posting a warning letter to an unidentified pharmaceutical company it represents.

Background

The petition for a stay of action-in plain parlance, a request to delay an action-was made by the law firm Hyman, Phelps & McNamara, widely known in the industry for its FDA Law Blog and representation of life sciences firms.

The petition, made to Commissioner Margaret Hamburg, asks her to "stay certain decisions identified in a 15 March 2013 letter from the Acting Director of the Center for Drug Evaluation and Research's (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance."

That letter, wrote attorney Douglas Farquhar, had denied the company's request to reconsider certain issues pertaining to a 21 February 2013 Warning Letter sent to the company. While the company had appealed that warning letter on 15 March 2013, it has not yet exhausted its appeals process, the law firm argues.

In addition, the letter also says that the company believes its intellectual property may be in danger if the letter is posted. The company's appeal argues that further redactions of information from the warning letter were needed to "protect its confidential information and/or trade secrets pursuant" to federal law.

Lawsuit a Possibility

The rest of the letter is just as intriguing. Farquhar goes on to explain that at least part of the contested warning letter pertains to a pharmaceutical product "that has never been commercialized in the US," and thus shouldn't be noted in the warning letter.

"As the drug has never been commercialized in the US, the Company believes observations regarding the Drug were inappropriately included in the Warning Letter," Farquhar writes.

Without the benefit of further appeals, the un-named company would be subject to "irreparable injury" by giving its competitors insight into its confidential manufacturing process, and would thus have grounds to sue the agency.

"Should FDA refuse to stay the Warning Letter's publication before the appeals process is exhausted, the decision to publish the letter constitutes a final agency action warranting judicial intervention [under Darby v. Cisneros]," Farquhar wrote.

No timeline for action is listed in the letter.


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