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Whistleblower Case Highlights FDA Confidentiality Concerns


Pharmaceutical Executive

New stories earlier this year (1) reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.

New stories earlier this year (1) reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.

David L Rosen

The scientists allegedly claimed that faulty review procedures led to the clearance of medical devices that exposed patients to dangerous levels of radiation, and raised questions surrounding the judgment and integrity of senior management officials in the Center for Devices and Radiological Health (CDRH). They questioned the approval of a premarket approval application supplement and clearance of certain 510(k) applications, and claimed that FDA senior managers in CDRH and the FDA Commissioner were corrupt and incompetent. In doing so, 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.

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.

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.

Companies spend huge amounts of money generating data to support the approval of pharmaceuticals, biologics, and medical devices, and they expect FDA to keep this information confidential and not disclose it to competitors or to the public while the review process is ongoing.  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.

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. They 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.

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. They 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. 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. BioCentury, July 23, 2012; New York Times, July 14, 2012.

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