FDA reveals final phase of Transparency Initiative
The FDA rolled out the first phase of its Transparency Initiative in January 2010 and the second phase in April 2010. The third phase includes a web-based resource called FDA Basics for Industry, to provide basic information on the regulatory process and answers to frequently asked questions – one of 19 action items outlined by the agency in a report entitled “FDA Transparency Initiative: Improving Transparency to Regulated Industry”.
FDA Commissioner Margaret Hamburg said: "Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health. In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates."
Other actions detailed in the report include improving availability of FDA presentations at key industry events; making more information on the product review process publically available; improving communication with importers; and pledging to answer questions from industry on the regulatory process within five working days.
Chairman of the agency's Transparency Task Force, principal deputy commissioner Joshua Sharfstein, said: "We have heard from small and large companies about the need for the FDA to more clearly communicate about its standards and expectations – both for regulated products generally and for specific applications.”
The full list of the agency’s items for action can be accessed here. The report also contains five draft proposals to improve the FDA's transparency to regulated industry, which will be open for comment for 60 days.
Phase one of the initiative involved launching an FDA Basics resource for consumers, while phase two concerned public disclosure of information, and is still under deliberation.
FDA Commissioner Hamburg set up the Transparency Initiative in June 2009 in response to President Obama’s pledge to increase openness in government.
At the end of a conference call with journalists about the initiative on Thursday, Sharfstein announced that he will be stepping down from his position at the FDA to become secretary of Maryland’s Department of Health and Mental Hygiene. Counselor to the commissioner, John Taylor, will take on the role of acting principal deputy commissioner for the next 60 days.
