FDA and the Importance of Confidentiality - Do you have to worry about FDA releasing confidential data? Apparently so. - BioPharm International

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FDA and the Importance of Confidentiality
Do you have to worry about FDA releasing confidential data? Apparently so.


BioPharm International
Volume 25, Issue 10, pp. 74, 73


David L. Rosen, BS Pharm., JD
Recent news stories have reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media (1, 2). These scientists claim that faulty review procedures led to the clearance of medical devices that exposed patients to dangerous levels of radiation (1, 2). The scientists raised questions regarding the judgment and integrity of senior management officials in the Center for Devices and Radiological Health (CDRH). In investigating the suspected leaks, FDA monitored the emails of these scientists through the use of sophisticated software that captured the keystrokes, keywords, and phrases of numerous individuals (1, 2). During the course of this monitoring, it appears that FDA may have gone beyond the scope of the initial suspected leak of confidential information by looking at protected information such as individuals' password-protected private emails, communications to Congressional staff and the US Office of Special Counsel, attorney and client communications, workplace grievances, and items protected by whistleblower statutes.

A NEED FOR CHECKS AND BALANCES

The Office of Special Counsel has found that the scientists' claims regarding the medical device review process were sufficiently valid to warrant a further investigation (1, 2). In taking a step back from the news stories, it can be agreed upon by those involved in the FDA review and approval processes that it is sound scientific and public policy to have checks and balances on the FDA review and approval process. FDA has internal procedures that permit and encourage the presentation and discussion of the interpretation of scientific data. Expressing the differing views of the product review team leads to a thorough evaluation and discussion of the data and, ultimately, to better decision-making on the review and approval process for FDA-regulated products.

Various positions regarding the interpretation of the data are discussed in a forum at FDA where the exchange of differing views on safety and efficacy data are presented to an experienced team of senior FDA staff. There is an opportunity for all team members involved to present their analysis and views on the risks verses benefits of products. Invariably, disagreements as whether the benefit of the product is acceptable in light of the risks may occur. In the end, FDA must make a decision as to the acceptability of the data and whether the application can be cleared or approved for marketing.

Ultimately, FDA senior management must weigh the scientific evidence and exercise their judgment and experience in making decisions on whether the data support the clearance or approval application. The American public puts its faith in processes and relies on the belief that FDA scientists and senior management review products and make decisions on the acceptability of the data. In my 30-plus years of experience in dealing with FDA-regulated products (including more than 14 years at FDA), I can personally attest to the fact that FDA staff take their responsibility for the review and approval of products seriously and work diligently to make decisions that are in the best interest of public health and safety.


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