FDA: Transparency Initiative

BIO’s comments on FDA Transparency Task Force’s Draft Proposals for Public Comment Regarding Disclosure Policies. BIO agrees that FDA should seek to make Agency activities and processes accessible to patients, physicians, health care providers, and all other stakeholders in a timely manner to improve credibility and public trust of the Agency. BIO’s concern is whether these efforts will appropriately protect confidential information. BIO is also concerned about: the focus of FDA’s initial transparency efforts, in light of limited Agency resources; whether the release of information would benefit the public health and serve FDA’s public health mission; what internal review and redaction measures would be employed; and what Sponsor notification measures would be employed.