Pre-Marketing Surveillance

  • by: |
  • 07/15/2012
Here is the FDA's statement on it's monitoring of certain employee computers:

The FDA takes very seriously our responsibility to safeguard the confidential information we receive each year from the industries we regulate as well ensuring the ability of employees to voice their concerns.

Shortly after learning that confidential information had been released outside the agency, the FDA initiated monitoring of a small number of FDA employees for whom the agency had evidence suggesting that they might be responsible for the unauthorized disclosure of proprietary information.

The monitoring was limited and intended to determine whether confidential commercial information had been inappropriately released to the public. The agency's monitoring was limited to the government-owned computers of five employees and was only intended to identify the source of the unauthorized disclosures, if possible and to identify any further unauthorized disclosures. These steps were taken because FDA, in order to serve the public health of the American people and respect the proprietary interests of the manufacturers, is statutorily required to protect commercial confidential information and trade secrets. The FDA is legally prohibited from releasing this information without legal authorization.

FDA did not monitor the employees’ use of non-government-owned computers at any time. Neither members of Congress nor their staffs were the focus of monitoring. At no point in time did FDA attempt to impede or delay any communication between these individuals and Congress. Employees have appropriate routes to voice their concerns without disclosing confidential information to the public, and FDA has policies in place to ensure employees are aware of their rights and options.

The FDA's ability to protect and promote public health in the U.S. is tied to our ability to protect confidential information. This allows us to work with industry to ensure the quality of FDA-regulated products and also encourages outside stakeholders to provide us with information that would allow the agency to identify any wrongdoing. 

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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