FDA Unveils First Phase of Transparency Initiative

The U.S. Food and Drug Administration has unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval process.

During an online presentation, the chair of the FDA’s Transparency Task Force, Principal Deputy FDA Commissioner Joshua Sharfstein, described a Web-based curriculum called “FDA Basics,” aimed at helping the public better understand what the agency does. The curriculum is accessible via a link on the FDA Web site.

The curriculum includes:

  • Questions and answers about the agency and the products it regulates
  • Short videos that explain various agency activities
  • Conversations with agency personnel about the work of their office

In addition, senior officials from FDA product centers and offices will answer questions on various topics during future online sessions. Each of these sessions will be announced on the FDA Web site.

In one of her first acts after assuming the office last spring, FDA Commissioner Margaret A. Hamburg, M.D. announced the formation of an internal task force to develop recommendations for enhancing the transparency of the FDA’s operations and decision-making processes.

“The launch of FDA Basicsis our first step towards making FDA a more transparent agency,” said Dr. Sharfstein.

In recent months, the Task Force solicited public input on improving agency transparency through a public docket, an online blog, and two public meetings. The Transparency Task Force received hundreds of comments from various stakeholders, including regulated industry, consumers, patients, health care providers, and others. As a result of comments from the public, the Task Force decided to develop its recommendations in three phases. FDA Basics represents the result of the initial phase, to be followed by two additional phases.

In phase two of the initiative, the Task Force intends to make recommendations to the Commissioner regarding how to make information about agency activities more transparent, useful, and understandable to the public, in a manner compatible with the agency’s goal of protecting confidential information, as appropriate.

In the final phase of the initiative, the Task Force intends to make recommendations to the Commissioner regarding FDA’s transparency to regulated industries.

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