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Transparency Industry Listening Session #2 Summary

Listening Session #2 (Conventional Food and Dietary Supplement Industries)
January 27, 2010
Silver Spring, MD

Industry Participants:

Douglas Mackay,
Vice President, Scientific and Regulatory Affairs,
Council for Responsible Nutrition

Deborah White,
Associate General Counsel, Regulatory Affairs,
Food Marketing Institute

Jeffrey Barach,
Vice President and Director,
Center for Technical and Laboratory Services,
Grocery Manufacturers Association

Rick Cristol,
Executive Director,
International Food Additives Council

Dave Gombas,
Senior Vice President, Food Safety and Technology,
United Fresh Produce Association

Summary of Listening Session:

The meeting was chaired by Joshua Sharfstein, MD, Principal Deputy Commissioner, FDA and attended by members of FDA’s Transparency Task Force, as well as the industry participants listed above. Industry participants offered the following suggestions for improving FDA transparency to regulated industry. The views presented here do not necessarily represent the views of FDA or the Transparency Task Force.

A. Getting Timely and Reliable Answers to Questions About Regulatory Issues

  1. Make it easier to find the right contact person within the agency to talk to about specific regulatory questions. Sometimes the FDA officials answering calls are not experts and can’t give reliable or rapid information on topics of great urgency to industry, or can’t explain how a guidance or rule would apply to a particular factual situation. Written questions sometimes take weeks to get answered. Providing more detailed organizational charts and more written Questions and Answers would be helpful.
  2. Create a web portal designed to answer questions that might be asked by regulated industry. Such a portal might be particularly geared to educating small businesses or new employees about FDA regulation. It can be difficult to find information about specific topics if you do not already know an appropriate contact person.

B. Providing General Education and Training

  1. Provide training to industry on what to expect when new laws are being implemented. For example, the dietary supplement industry would benefit from information on how to prepare for FDA’s implementation of the new Good Manufacturing Practices and Adverse Event Reporting requirements applicable to their industry.
  2. Update guidances and give more presentations to industry reflecting what the agency has learned from the process of conducting inspections and implementing new policies.

C. Maintaining Open Communication

  1. Hold information-sharing meetings with industry on a regular basis. It’s easier for both FDA and industry to communicate issues and concerns when there is no crisis at hand, and might decrease requests for ad hoc meetings on specific issues. FDA already does this with the makers of OTC drugs.
  2. Continue to share and receive information from regulated industry during rulemaking and outbreaks. FDA officials become difficult to contact during these periods, even when regulated industry wants to share information that might be relevant to an ongoing investigation. It would be useful to identify a standing person or avenue of communication for industry to use during such periods.
  3. Provide more information on how FDA works with other federal agencies on topics of relevance to regulated industry. There is often no information available to industry on these collaborations.
  4. Disclose more about which agency offices are working on specific issues of importance to regulated industry. Sometimes even FDA officials are unaware of the work going on in other offices on topics of concern to them.
  5. Reinstate the practice of publishing the agency’s strategic plans, with a list of agency priorities. FDA used to do this and it helped industry understand which issues FDA regarded as most important.

D. Emerging Safety Issues

  1. Communicate with industry earlier in the process of identifying an emerging safety issue with a particular product. Waiting until FDA thinks a recall is necessary is too late, both for allowing the affected company to provide information to FDA and for preparing for the recall. In the dietary supplement area, some companies would like to hear early of FDA’s concerns with a particular ingredient, so that they can remove it from their products.

E. Status of Pending Documents

  1. Provide more information on the status of pending rules and guidances. Sometimes, FDA initiates a proposed rule or draft guidance, solicits comments, and then is silent for years about whether and when it intends to finalize the document. Companies may be confused about what rules and policies to follow in the interim.
  2. Provide more information about the status of food additive petition reviews. Some petitions have been under review for many years and it is unclear to industry what the obstacles to completion are, and what the petitioner can do to move the process forward.

F. Information Collection

  1. Make it easier for industry to get copies of survey documents that FDA announces in the Federal Register when it initiates the collection of information about a topic. Industry members want to be able to comment on the actual survey, but getting copies is difficult.