On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA) with respect to a biotechnology product that relies, directly or indirectly, on trade secret and confidential commercial data and information of an innovator.
The Petition argues that moving forward with either a draft guidance document or product approval under 505(b)(2) would necessarily violate an innovator's legal rights in trade secret and confidential commercial data and information, and raises serious public health concerns.
Specifically, the Petition argues that FDA's formulation and implementation of a generic biologic policy based on a draft "similarity" guidance document and related approvals would rely on trade secret and confidential commercial data and information, in violation of protections provided under section 505(b)(2) of the FDCA, the Trade Secrets Act and the United States Constitution.
Further, the Petition argues that current science does not allow for reliance on analytical data generated from one biotechnology product to support approval of a product manufactured through different processes. Complex operational and proprietary details of the manufacturing processes are central to and define the identity and unique molecular safety and effectiveness attributes of each biotechnology product.
The Petition states that without first examining trade secret data concerning the manufacturing processes of the innovator, which is prohibited by law, agency reviewers simply cannot perform the rigorous scientific comparative assessment necessary to reach legitimate conclusions about the "similarity" or "sameness" of two products. Therefore, Genentech does not believe that FDA can draft a guidance document or safely approve a biotechnology product based on "findings" about a Genentech product without relying - directly or indirectly - on trade secret and confidential commercial data and information provided to FDA for the explicitly limited purpose of reviewing Genentech products and the specific processes used to make them.
For decades, the FDA has correctly taken the position that each biotechnology product is unique, and inexorably linked to and inseparable from the manufacturing processes used in its creation. The agency has consistently protected the trade secret and confidential commercial data and information provided to it concerning biotechnology products through its regulations and administrative practices.
These principles and practices have established the regulatory and legal foundation on which innovators have submitted marketing applications to FDA for its review. However, it is apparent that FDA is now backing away from this long-standing position.
Genentech supports continued application of FDA's traditional approach to "paper NDAs" under section 505(b)(2) of the FDCA. This approach allows for approvals to be based on clinical and other data and information appearing in publications, or through processes, which are patented and later made available publicly. The line should be drawn, however, at agency reference to or reliance on innovator trade secret and confidential commercial data and information to approve a competitor's product.
The Petition requests that the agency re-assess its approach to approvals of follow-on biologics, and put processes in place to protect trade secret and confidential commercial data and information from use and disclosure by others.