The attached letter from FDA’s Chief Operating Officer responds to Congressional concerns about agency regulatory actions that could increase the vulnerability of generic pharmaceutical manufacturers to lawsuits. The FDA letter suggests that the agency routinely violates the Public Participation section of President Obama’s Executive Order on regulatory review, 13563. FDA states:
FDA generally declined requests for meetings related to this issue pending publication of the proposed rule. Other than through review of the petition described above and of the comments on the petition and of correspondence from members of Congress and the public, FDA did not consult with outside parties. While FDA generally does not participate in a dialogue during the development of proposed rules, there are occasions when FDA staff will participate in a listen only session with interested parties.