As part of its ongoing transparency initiative, the U.S. Food and Drug Administration has issued 19 action items including a new website to help the industry save time and resources in its interaction with the agency.
FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) includes information about the regulatory process, particularly that information frequently requested by industry.
“Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health,” said FDA Commissioner Margaret Hamburg, M.D. “In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates.”
All of the action items are listed in a 46-page report titled “FDA Transparency Initiative: Improving Transparency to Regulated Industry,” which also contains five draft proposals to improve FDA’s transparency. The draft proposals, available for public comment for 60 days, include publishing a timeline on the FDA website for high-priority guidance documents in development.
“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,” said Principal Deputy Commissioner Joshua Sharfstein, M.D., chairman of the agency’s Transparency Task Force. Sharfstein, the FDA’s number two official, just announced he is leaving the agency after 21 months to take the top public-health job for the state of Maryland.
Commissioner Hamburg launched the FDA’s Transparency Initiative in June 2009 in response to both President Obama’s commitment to openness in government and steps taken by the U.S. Department of Health and Human Services to make transparency a priority. Since then, the FDA has launched its FDA Basics web page, which features questions and answers, videos and other materials describing how the FDA works to protect and promote public health. The page has been viewed by more than 900,000 worldwide.
The agency also has established an online performance program for FDA offices nationwide. Called FDA-TRACK, it features monthly metrics for more than 100 agency offices and provides insight for the public into the FDA’s decision-making and regulatory activities.
The FDA’s 19 action items include:
▪ Setting an agency-wide expectation that email questions to the FDA regarding an existing policy or the regulatory process will, whenever possible, receive an answer within five business days, or a response stating when an answer can be expected
▪ Posting on the FDA website slide presentations made by FDA employees to outside audiences at FDA-sponsored events
▪ Providing links to the processes available for industry to submit general regulatory questions to each center
▪ Compiling all FDA Center guidance and standard operating procedures on FDA employees meeting with sponsors about product applications on the new website
▪ Describing the types of notifications the agency provides to industry in the product application review process and providing an overview of the processes used to strive for consistency of product application review
▪ Communicating general expectations about the circumstances, if any, under which it is appropriate to use secure email between FDA and a manufacturer when there is a question involving the manufacturer’s product
▪ Explaining how a sponsor is informed about whether the review of its product application is on track to meet the target date for FDA action; discussing application tracking systems with industry and exploring the feasibility of implementing such a system
▪ Forming a cross-agency workgroup to identify best practices for improving the agency’s work on guidance
▪ Describing ways in which interested individuals can provide input to the agency about guidance development; providing links to a list of guidance documents that have been withdrawn during the past year and possible topics for future guidance development or revision in one location on the FDA website.
—Staff and wire reports