The U.S. Food and Drug Administration (FDA) has primary responsibility for oversight of every drug, biologic, and medical device sold in the United States, explain Joshua M. Sharfstein, MD and Michael Stebbins, PhD in an article featured in the Journal of the American Medical Association.
Yet the FDA is far more than a regulator, they say. “It is also an agency dedicated to public health, with the expertise of thousands of scientists and access to enormous amounts of information from clinical trials and other studies. Greater transparency can allow FDA not only to better meet its many obligations but also to advance the scientific enterprise needed to develop safe and effective medical products.”
The authors explain that in 2009, “FDA launched an initiative to make more regulatory decisions and analyses available to the public. After receiving extensive comment, the agency developed a series of draft proposals. Although FDA moved some of these proposals forward, others were never implemented.”
Sharfstein and Stebbins believe there is now broader recognition in the biomedical community of the value of transparency. Researchers from a number of institutions met to create a new Blueprint for Transparency at FDA. Invited patient advocacy organizations, consumer groups, clinicians, legal scholars, practitioners, and industry representatives provided input on early drafts. The FDA provided technical comments, the authors said.
“The report makes 18 recommendations in 5 principal areas. More broadly, the blueprint sets out an approach to leverage the regulatory process to advance scientific understanding, patient care, and public health. All the recommendations, by design, can be implemented by the agency under existing statutes without additional action by Congress. None are part of the 21st Century Cures Act, which focused on supporting future drug development directly rather than on transparency,” Sharfstein and Stebbins said.
This new approach to transparency will impact animal agriculture and the process of how drugs are approved. Take some time to read the article and look over the group’s recommendations here.