The US Food and Drug Administration has unveiled the first phase of its Transparency Initiative: a new website called FDA Basics provides the public with detailed information on what the agency does, who works there, and how regulated products are approved for the marketplace.
The effort began last spring with a Transparency Task Force, created in June 2009, in response to the Obama administration’s open-government approach and with the support of the Department of Health and Human Services, said Joshua Sharfstein, MD, FDA’s principal deputy commissioner and chair of the task force, in a media briefing on Jan. 12, 2010. The agency launched a transparency blog last year to collect comments and suggestions and has held a series of public meetings on the subject. The task force received more than 900 comments, representing the public, consumers, and industry, said Sharfstein. People seem to want to know more about the drug-approval process in detailed, consumer-friendly language, he explained. In other words, they know a lot about consumer products, but they don’t know what went into the decision-making process to allow those products to get on the shelf.
The task force used the feedback to shape its agenda and three-phase plan, the first phase being the website. The FDA Basics website includes questions and answers (the public can submit more questions as time goes on), short videos (including an “on-the-record” series featuring FDA personnel describing their daily work), and online forums in which the public can engage with FDA personnel. Topics addressed include the product areas regulated by FDA such as drugs, dietary supplements, food, medical devices, and tobacco.
Phase 2, expected at the end of February, will involve a set of recommendations for the FDA Commissioner to make the agency’s activities more transparent, useful, and understandable to the public, according to an FDA press release. In other words, explained Sharfstein during the briefing, the task force will identify what types of information FDA can make accessible to the public regarding agency decisions on regulated products. This may include the publication of more redacted communications between the agency and industry about specific drug applications. But that is a hefty task, pointed out Sharfstein, because redaction in itself can be a complicated and lengthy process. In addition, there are so many different parts and scenarios to the application process that it will be challenging to figure out which parts should be made public and at what stage of the process.
Phase 3, expected this summer, will also involve a set of recommendations for the FDA Commissioner, with this set focusing on what information can be made more transparent to the regulated industries.
“This is a step to making FDA a more open and transparent agency,” said Sharfstein, adding that the website provides a new way for people to interact with the agency.
In fact, members of FDA’s Office of Generic Drugs review team recently published a paper on Common Deficiencies in ANDAs with PharmTech. The paper is meant to provide industry with information about the CMC section of their abbreviated new drug applications by offering concrete examples and recommendations. This is the first time the agency has provided so much detail on a typically nontransparent process.
It’s wonderful to see this kind of openness from a federal agency. The initiative can go a long way toward educating the public about what FDA does—and how—and also provide industry with real-time answers to their daily challenges, ultimately improving product quality and patient safety.