THE IMPORTANCE OF CONFIDENTIALITY
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.