FDA principles, policies, and procedures related to scientific integrity
Science—both its quality and integrity—is the touchstone of everything we do at FDA. In conducting our mission to protect, promote, and advance the public health, FDA needs the best scientific and technological information available to make decisions on the products we regulate. Critical to our ability to reach sound decisions and to retain the public's trust are high-quality data and a scientific review process that is thorough and unbiased.
Our scientific experts may hold differing views on what they conclude from data. There may be multiple options that can be considered during policy development or regulatory decision-making. However, in reaching our conclusions through a deliberative scientific process, FDA strives to present an evaluation and analysis of the data—including uncertainties—in an unbiased manner.
FDA has a long and continuing history of promoting an environment of robust scientific debate, where the integrity of information is ensured, all views are carefully considered, and scientific decisions are protected from political influence. In 2009, we established FDA's Office of Scientific Integrity (OSI) within the Office of the Chief Scientist. OSI works to:
- ensure that FDA's policies and procedures are current and applied across the Agency;
- resolve scientific disputes that may arise internally or externally and that are not resolved at the Agency's Center levels; and
- advise the Chief Scientist and other senior FDA leaders on appropriate responses.
To ensure that we maintain a highly skilled scientific staff capable of addressing the regulatory challenges presented by new areas of science, the Agency established the Office of Scientific Professional Development. And in response to a 2009 directive from the President’s Office of Science and Technology Policy to develop policies and procedures as a means of ensuring scientific integrity in agency decision-making, FDA also issued an Agency-wide policy that presents key principles of scientific integrity and highlights important procedures and policies we have implemented at FDA that advance those principles.
FDA product centers implement and following the general principles and procedures outlined in this policy. The policies, procedures, and initiatives related to or supporting scientific integrity at FDA listed below are updated regularly.
Agency-wide Efforts Supporting Scientific Integrity
- FDA's Transparency Initiative
- Scientific Publications by FDA Staff
- Advisory Committee Oversight and Management Staff
- FDA Sexual Harassment Policy Concerning Extramural Research
- Public Access to the Results of FDA-Funded Scientific Research
- A Key FDA Resource for Industry and the Public: Working with the FDA Office of the Ombudsman (Archived)
Resources For You
- Office of Scientific Integrity
- The FDA Ombudsman
- Guidance for Industry: Preparation and Public Availability of Information Given to Advisory Committee Members
- Strategic Plan for Risk Communication and Health Literacy (SPRCHL), 2017 - 2019