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Do you have to worry about FDA releasing confidential data? Apparently so.
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.
David L. Rosen, BS Pharm., JD
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.
In the recent situation reported in the media, the scientists questioned the approval of a premarket approval application supplement and clearance of certain 510(k) applications (1, 2). The scientists claimed that FDA senior managers in CDRH and the FDA Commissioner were corrupt and incompetent (1, 2). The scientists reportedly publicly disclosed company confidential, commercial, trade secret information to the media in airing their concerns regarding the decisions made to approve or clear certain medical devices for marketing (1, 2). It is surprising and disturbing that the FDA scientific reviewers leaked confidential commercial information to the press. FDA regulations are clear: if the existence of a premarket submission has not been publicly disclosed and the submitter requests that the intent to market a device remain confidential, provides a certification to the Commissioner requesting confidentiality, and complies with various provisions regarding the maintenance of such confidentiality, then FDA will not disclose the existence of a premarket notification. This relates to existence and the intent to market a medical device, which is evident by the submission of a 510(k) application. There are similar confidentiality provisions relating to investigational products, full and abbreviated new drug applications, biologic license applications, and premarket approval applications. The news media has reported not only the existence of the companies intent to market certain medical devices but appears to have received internal agency files, documents, and confidential commercial information from FDA reviewers (1, 2). It is disturbing that an FDA contractor also apparently inadvertently made accessible over its website a significant amount of sensitive FDA documents (1, 2).
Companies spend huge amounts of money generating data to support the approval of pharmaceuticals, biologics, and medical devices. Companies expect that FDA will keep this information confidential and will not disclose it to competitors or to the public while the review process is ongoing. Disclosure of confidential information prior to a company receiving marketing approval or clearance can cause significant economic harm. Competitors can get advance notice of the products under review and adjust their marketing plans for competing products. Competiors may also use this information to further develop their own products.
FDA staff, outside contractors, special government employees, advisory committee members, and others who have access to company confidential, commercial, and trade-secret information must take their obligation to keep such information confidential seriously. FDA staff and others should not make the decision to disclose confidential information to the media just because they may disagree with or are challenging the scientific judgment of their superiors. FDA staff must follow the procedures established to present differing views of scientific data and the conclusions drawn with respect to safety and efficacy. If certain members of the FDA review staff disagree with the decision to approve or clear a product, they can document such objections in writing. If the review staff question the approval decision because they believe it was not supported by the clinical data, the public safety is at risk, the review process was compromised, or that there was corruption or incompetence uncovered during the review process, there are procedures that can be utilized to report such allegations. Staff can always raise concerns with internal management structure at FDA, Health and Human Services, the Office of Special Counsel, the President's staff, or through Congress. When raising the concerns up the chain of command, staff are well advised to present their allegations and documentation to support their assertions in an organized, responsible manner.
As part of routine procedure, companies identify the parts of their submission (e.g., 510(k), PMA, NDA, and ANDA) that are considered confidential, commercial, trade secret information. Prior to approval or clearance, FDA is obligated to maintain that confidentiality. How should the agency ensure this confidentiality? It has been suggested by the attorney representing the whistle blowers that FDA have different computers and systems for maintaining confidential information that do not have, for example, Internet access. This is an expensive option; therefore, FDA staff should be trained and reminded on a periodic basis of their responsibility and obligation to maintain the confidentiality of submissions. If FDA staff members feel compelled to discuss concerns with the media, they can have these discussions without disclosing confidential information.
In closing, members of the FDA staff must understand and appreciate their obligation to maintain the confidentiality of submissions and not disclose confidential, commercial, trade secret information to the media. There must also be checks and balances on the review process. FDA staff should be aware of and follow procedures for raising scientific concerns that can impact the public health and safety. Ultimately, the public must continue to have confidence that FDA is making sound decisions on the approval and clearance of products.
David L. Rosen, BS Pharm., JD, is co-chair of the Life Sciences Industry Team and an FDA Practice Group Leader at Foley & Lardner LLP.
1. S. Usdin, BioCentury, 20 (30), July 23, 2012.
2. E. Lichtblau and S. Shane, New York Times, July 14, 2012.