Public access to the results of FDA-funded scientific research furthers the Agency’s public health mission. The broad availability of scientific information and underlying data allow for the critical review, replication, and verification of findings that are central to the scientific method.
Making research findings and the digital data supporting those findings accessible and analyzable promotes robust and open communication with the scientific community thereby bolstering the credibility of scientific findings and the regulatory decision-making based upon those findings. The availability of FDA scientific information advances public health by spurring scientific discovery, including prompting the scientific community to address critical challenges in medical product development.
Facilitating the free flow of information underlying FDA's decision-making and advances in regulatory science--to the extent permitted by law--enables the public, Congress, media, and industry to better understand FDA’s decisions and the scientific basis for its regulatory decision-making.
On February 22, 2013, the White House Office of Science and Technology Policy (OSTP) issued a memorandum to the heads of executive departments and agencies titled "Increasing Access to the Results of Federally Funded Scientific Research." In the memorandum, OSTP asks Federal agencies with research and development budgets greater than $100 million per year to develop a plan to ensure free public access to Federally funded, peer-reviewed scientific publications and to maximize public access—to the extent feasible and permitted by law—to digital data resulting from Federally funded research.
FDA shares the objectives of transparency and maximizing public access to FDA-funded research. Accordingly, FDA has developed a policy for public access to FDA-funded peer-reviewed publications and digitally stored data.
As FDA implements the policy, we will use this space to provide resources to educate the public, FDA scientists, and FDA-funded researchers about Agency public access policies and the tools for complying with those policies.
White House Memoranda and Orders
Increasing Access to the Results of Federally Funded Scientific Research, Office of Science and Technology Policy, February 22, 2013.
Making Open and Machine Readable the New Default for Government Information, Executive Order 13642 of May 9, 2013.
Open Data Policy-Managing Information as an Asset, Office of Management and Budget, May 9, 2013.