Keeping the Focus on Scientific Integrity

By: Jesse L. Goodman, M.D., M.P.H.

Science, both its quality and its integrity, is key to everything we do at FDA. As a physician and researcher, science has always been central to the decisions I make at the bench or at the bedside.  And now as the Chief Scientist for FDA, my office works across the agency to support our scientists and their cross-cutting scientific and public health efforts – and to help ensure that our decisions are science-based and protect and promote the health of the American people.

On a daily basis, I’m impressed with the professionalism of my colleagues and the thoughtful scientific discussions that help inform the important decisions we make.  While there may be differing views of what we can or cannot conclude from the science and data on which we rely, and while there are often multiple options that can be considered in developing a policy approach or making regulatory decision, FDA’s scientific decision-making on difficult issues must always be the product of an open and honest debate by the agency’s well-qualified employees. It is for these reasons that we stood up two new offices within the Office of the Chief Scientist whose missions explicitly include supporting Scientific Integrity (OSI) and Scientific and Professional Development (OSPD).

As reflected in the results of a survey of FDA scientists published by the Union of Concerned Scientists (UCS) today, with all of your help, FDA continues to make major strides in the area of scientific integrity.  The overall response rate of FDA employees to the survey was low and makes definitive conclusions difficult.  But, when compared to the results of a similar survey in 2006, which had a similar response rate, respondents have developed more confidence in the agency’s approach to science and the integrity of FDA leadership.  For example:

  • Scientists have more respect for overall agency leadership and their supervisors.
  • Supervisors show more support for scientists pursuing potentially contentious research.
  • Scientists feel better supported in pursuing professional development.

Even though, as noted, the opinions of those responding to the survey are generally more positive than in 2006, and even though the percent of respondents is low and may not accurately represent all employees’ views, there are some findings that should still concern us.   For instance:

  • Some scientists still fear retribution for sharing concerns about the FDA.
  • Some believe that business interests frequently influence science-based regulatory decisions.

Preserving and protecting scientific integrity and working to promote an environment where all feel comfortable expressing their opinions and have confidence in the Agency’s decision-making, must be an ongoing effort and part of our daily life and culture.

To that end, we recently put in place an agency-wide policy that sets forth key principles of scientific integrity and highlights important procedures and policies we have put in place at FDA that further those principles.  OSI, and myself as Chief Scientist, are committed to continuing to work with all of FDA to promote scientific integrity.  As set forth in the staff manual guide (SMG) on scientific integrity, FDA supports the following key principles:

Key Principles of Scientific Integrity at FDA

  • Maintaining a firm commitment to science-based, data-driven decision-making;
  • Shielding the agency’s science and its scientific staff from political influence;
  • Facilitating the free flow of scientific and technical information;
  • Protecting the integrity of scientific data and ensuring its accurate presentation, including the underlying assumptions and uncertainties;
  • Requiring a fair and transparent approach to resolving internal scientific disputes, including hearing and carefully considering differing views;
  • Supporting whistleblower protections;
  • Selecting and promoting scientists based on their knowledge, expertise and integrity;
  • Utilizing peer review of data and research used in decision-making, where feasible, appropriate and consistent with the law;
  • Maintaining openness and selecting qualified advisory committee members based on expertise, with transparency about conflicts of interest;
  • Allowing FDA staff to communicate their personal scientific or policy views to the public, even when those views differ from official Agency opinions; and
  • Promoting the professional development of our scientists by encouraging publication in and editorial service to peer reviewed journals, presentations at professional meetings, and full participation in appropriate professional or scholarly societies and related activities that may benefit the public health.

Dr. Hamburg and I are strongly committed to these principles and will continue to support FDA’s staff in its pursuit of scientific excellence and integrity in providing, reviewing, and disseminating data used to make decisions that affect the health and safety of people every single day. While everyone may not always agree on a complex decision or policy, and while we often must act in the face of real uncertainties, we must do so with the highest integrity. And though this survey helps confirm that we are making progress, protecting scientific integrity will require continuing commitment and attention. I welcome your ideas and suggestions.

Jesse L. Goodman, M.D., M.P.H., is FDA’s Chief Scientist and Deputy Commissioner for Science and Public Health