Is FDA putting your company’s confidential data at risk?

September 27, 2012
Susan Haigney

Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe,

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.  Earlier this year, the New York Times reported that FDA had tracked employee emails in its investigation into the possible leak of agency information by FDA scientists who complained about the agency’s medical device review process. These scientists raised concerns about radiation danger levels.

This situation is disconcerting on a few levels. First, and most important in my opinion, is the initial problem of a potentially faulty review process that may have allowed unsafe medical devices to reach patients. Second, and certainly a concern for manufacturing companies, is the potential leak by FDA employees of confidential data that had been submitted to FDA with the assurance that it would stay within the agency. And third, is the fact that a government agency may have violated the private correspondence, some of which may be protected under whistleblower laws, of its employees.

Were the FDA staff members who allegedly leaked confidential company data right for doing what they did? Pharmaceutical companies rely on FDA to protect confidential scientific data that may be crucial to their future business; however, employees should feel safe to express important concerns. Ultimately, it is FDA’s job to protect health. It’s a sticky situation that should be addressed.

Does FDA need to have a better system in place for employees to voice concerns while also protecting confidential data?

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