The U.S. Food and Drug Administration (FDA) Tuesday rolled out the first phase of its Transparency Initiative, which is designed to explain agency operations, how it makes decisions, and the drug approval process.

FDA Transparency Resources.jpg In 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, and 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.

“This initiative will make information about the FDA more user-friendly and accessible to the public,” said Dr. Hamburg. “It fosters a better understanding about what we do.”

“The launch of FDA Basics is 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.

  • Mark FeDuke

    Funny thing about this transparency initiative is that it doesn’t seem to apply to food despite the well shot photos above of what look to be very appetizing dishes. Great to know that the FDA regulates tongue depressors and MRIs but there’s zero about food in the Q&A section. FDA Basics invites you to search all of FDA Basics…type in food imports and hit search…and 4 hits come back…2 in English about importing drugs and their translations in Spanish but not a lick about food. The FDA did initiate a Qualified Trusted Import Program (QTIP) but oopps its not for the food industry but you can report on yourself if you find something harmful in the foodstuffs you import. For those of us that pride ourselves as responsible food importers engaged in import security/food defense best practices and wanting to engage with the FDA in a meaningful way…the FDA seems to stand for the Federal Drug Administration. While US customs agents from the DHS C-TPAT program have evaluated our supply chain and have joined us in visits to foreign vendor food processing facilities….its good to know folks importing tongue depressors qualify for the FDA’s qualified trusted importer status….