5C. FDA Transparency Initiative
Since June 2010, FDA has made substantial progress towards the goals of its Transparency Initiative. Among other things, FDA has issued two major reports proposing new disclosure initiatives and launched a second website (FDA Basics for Industry), in addition to its initial FDA Basics website. Below, we provide updated information on each of the 3 phases of the Transparency Initiative identified in the 2010 report.
Phase I: FDA Basics
This resource now includes (1) 156 questions and answers about FDA and the products that the agency regulates, (2) eight short videos that explain various agency activities and (3) conversations with 14 agency officials about the work of their offices. The site has received over 1.2 million visits since launch. The videos have received over 20,422 views, and the agency has received over 9,000 comments and ratings from the public. Feedback provided by the public is used to update the resource. There is now a section of FDA Basics that allows visitors to see the number of comments and ratings as well as the average score of ratings per product category (accessible online at http://www.fda.gov/AboutFDA/Transparency/Basics/ucm1176986.htm). Visitors can also see the web traffic to this section by month in this metrics section.
Each month, senior officials from FDA product centers and offices host 30 minute online sessions about a specific topic and answer questions from the public about that topic. So far, FDA has hosted 13 webinars with the average number of attendees being around 200.
Phase 2: Public Disclosure
On May 19, 2010, FDA issued a draft set of 21 proposals for disclosing information on a range of topics, including adverse event reporting, enforcement actions and letters, import procedures, inspections, as well as the existence, status, and content of product applications, and recalls (report accessible online at http://www.fda.gov/AboutFDA/Transparency/PublicDisclosure/default.htm). FDA received 145 public comments on the draft proposals. FDA has reviewed the comments, and has conducted resource, legal, and priority assessments to determine which proposals to implement and in what order. FDA has implemented 4 of the proposals, including the launch of a database providing information about all the inspections related to marketed products that the agency has conducted, and has announced plans to implement 3 more before the end of the year.
Phase 3: Transparency to regulated industry
On January 6, 2011, after holding 3 listening sessions with industry and receiving written comments, FDA released a report containing 19 action items and five draft proposals to improve transparency to regulated industry (accessible online at http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencytoRegulatedIndustry/PhaseIIITransparencyReport/UCM239088.pdf), including a web-based resource called FDA Basics for Industry to provide basic information about the regulatory process, including information that is frequently requested by industry. FDA sought public comment on the report. The comment period closed on March 6, 2011.
On the same day that the report was released, FDA launched FDA Basics for Industry. This resource includes: easier access to frequently requested content including guidance documents, information about the review process, and registration and listing information; links to training modules for industry, such as the Center for Devices and Radiological Health’s CDRH Learn educational tool; answers to questions frequently asked by industry including a rating system so visitors can rate the helpfulness of the answers; and an interactive flowchart that helps industry determine whether or not their product is regulated by FDA.
Since launch, FDA Basics for Industry has received over 68,000 visits.