David L. Rosen, BS Pharm., JD
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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.
