Archive for October, 2011

Update on Retrospective Review of FDA Regulations

October 26, 2011 40 comments

If you’ve been following this blog you know that earlier this year, President Obama issued Executive Order (EO) 13563 and outlined his plan to create a 21st-century regulatory system that is simpler and smarter and that protects the health and safety of the American people in a pragmatic and cost-effective way.  One of the goals of EO 13563 is to target rules already on the books and revise regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules.

On June 3, 2011, we announced, as part of the Department of Health and Human Services (HHS) retrospective review plan, that the first of our regulations to be reviewed under this EO would be the “Bar Code Rule.” You can see the HHS plan in its entirety at   The Bar Code regulation, which was finalized in 2004, requires certain human drugs and biological products to have a linear bar code on the label so health care professionals can use bar code scanning equipment to verify that the right drug (in the right dose and route of administration) is being given to the right patient at the right time.

In the seven years since this regulation was issued, there have been advances in alternative technologies.  In addition, it has become increasingly clear from industry, health care providers, and other FDA initiatives, that certain FDA-regulated products present unique bar coding concerns.  For example, the Agency has since learned that certain vaccines present unique challenges in the bar coding context, particularly with respect to compliance with recordkeeping and mandatory adverse event reporting requirements that are specific to the administration of childhood vaccines.

We are pleased to announce that today FDA issued a Federal Register notice seeking public input on the Bar Code rule.  You can see this notice at  We are requesting comments and supporting information on Bar code labeling standards for drugs and biological products and the identification of current alternative technologies for use by industry and others.

To facilitate this discussion with you, in the notice we have included some questions for you to consider.  These questions, which are not meant to be exhaustive, are provided to stimulate public comments that will help us evaluate the Bar Code rule and the accommodation of alternative technologies to the linear bar code requirement.  You are encouraged to address these and/or other related questions, so please review the notice at and submit your comments to our docket.  We look forward to hearing your thoughts and ideas.

Stay tuned as we continue reviewing our regulations at FDA.

Leslie Kux

Assistant Commissioner for Policy


Clark Nardinelli, FDA Chief Economist

Fulfilling the Promise of the Food Safety Modernization Act: The Importance of Stakeholder Engagement

October 24, 2011 30 comments

Recently, I had the good fortune to fill in for an FDA colleague on a panel entitled, “Assuring the Safety of Imported Food” at the National Food Policy Conference, which is organized by the Consumer Federation of America.

Participants at the conference included a broad spectrum of activists, public officials, nutrition professionals, farm and food industry representatives, and scientists who are interested in agriculture, food and nutrition policy.  The Food and Drug Administration Food Safety Modernization Act (FSMA) was one of the key areas of focus at the conference.

Even though I was called from the audience to participate unexpectedly in the panel, I hoped my role as Vice-Chair of FDA’s FSMA Imports Implementation Team would stand me in good stead. Fortunately, the other panelists spoke first, which gave me the chance to organize my thoughts.

My fellow panelists, Caroline Smith DeWaal, from the Center for Science in the Public Interest, Mike Robach, from Cargill, and Eduardo Santos from Allen F. Johnson and Associates spoke eloquently on the challenges and opportunities that the imports provisions of FSMA represent to consumers, industry, and other countries.   They identified various key issues associated with FSMA implementation including the costs associated with implementation, training, capacity building in exporting countries, and ensuring both accountability and fairness.

In addition to emphasizing some of the main features of the FSMA imports provision, I discussed how FDA is approaching the task of developing over 50 deliverables mandated by FSMA, our outreach strategy, the importance of making sure our actions are consistent with our WTO obligations, and the overarching need for stakeholder involvement.

The main message I hoped to leave with the audience was the importance of their role as stakeholders in providing information, practical scenarios, and data as we proceed with FSMA implementation.  FDA’s significant and ongoing effort at early engagement via public meetings has already provided FDA with many useful insights. I encouraged stakeholders to use the “notice and comment” process to continue to provide information and feedback in response to upcoming proposed regulations.

The task before us is huge. Currently, there are over 160 countries exporting hundreds of thousands of FDA regulated food products to the U.S.  How do we collectively assure safety?  How do the import provisions consider domestic provisions? FSMA provides the framework to harness leading business global food safety practices, consumer expectations and importer practicalities, with agency standards and oversight.  We have a long way to go before we fully implement FSMA, but we have the platform on which to build and I am confident that we are up to the task at hand.

During the conference, Secretary of Agriculture Tom Vilsac, CDC Director Thomas Frieden, and FDA Commissioner Margaret Hamburg highlighted the work of their respective agencies in addressing nutrition and food safety issues. They each echoed the importance of food safety and the public imperative for stakeholders to work together to optimize the safety and nutritional adequacy of our food supply.

Dr. Hamburg started her speech with, “Will Rogers liked to say that most political promises are about as solid as applesauce… (and FDA regulates applesauce!)  But some promises are just too important not to keep… like the promise that our food supply will be safe for every American.”

Each of us has a stake in bringing this promise to life.  The National Food Policy Forum was a terrific opportunity to be inspired, to strengthen our resolve, and to keep the stakeholder momentum moving ever forward.

Camille Brewer
Acting Deputy Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition
Senior Advisor for International Affairs, Office of Foods, Office of the Commissioner
U.S. Food and Drug Administration.

Upcoming Event: Webinar on FDA’s MedWatch System: How to Report Adverse Events

October 18, 2011 18 comments

Did you know that you can report problems that you have had with drugs and other medical products to the FDA? Did you know that MedWatch can send safety alerts directly to you, as soon as they appear on the web site?

The FDA will host a webinar “FDA’s MedWatch System: How to Report Adverse Events”. The featured speaker, Brenda Rose Pharm.D., a Health Programs Coordinator in FDA’s Office of Special Health Issues will give an overview and answer questions about how to report adverse events to MedWatch.

The free 30 minute webinar will be held Thursday, October 20th at 11 AM ET.

There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.

Learn more about the webinar, including instructions about how to join.

FDA’s New Outbreak Director: Learning from Outbreaks is the Key

October 6, 2011 63 comments

(from left to right) Commissioner Margaret Hamburg; Dr. Kathleen Gensheimer; Sherri McGarry, CORE Senior Advisor; Michael Taylor, Deputy Commissioner for Foods

The best way to get into the Gulf of Maine in August is to jump feet first. So, “jump feet first” is what I did this week on my first day as chief medical officer and director of outbreaks for the FDA Coordinated Outbreak Response and Evaluation (CORE) Network.

CORE, with a dedicated multi-disciplinary staff, is meant to provide a streamlined, integrated approach to how FDA not only responds to human and animal foodborne illness outbreaks, but how we improve surveillance and post-response efforts, to apply lessons learned and prevent future outbreaks.   When an outbreak happens, the CORE staff will decide the strategy of FDA’s response, working closely with the FDA field staff, and coordinate with other key federal, state and local food safety agencies.

After 28 years as Maine’s state epidemiologist, the management of outbreaks is vital to me, but even more important is learning from them in order to prevent or minimize future outbreaks.  That’s what public health’s emphasis on preventive medicine is all about.

So, when asked what I wanted to do on my first day, I said hear firsthand from some of our partners, both inside FDA and outside.

I was able to briefly introduce myself to a crucial component of the CORE Network – the FDA Regional and District offices, during one of their regular weekly conference calls.  CORE is already coordinating and will continue to work closely with the Districts during outbreak response and related activities, building on the best of what FDA has done in the past, and finding ways together to improve and streamline our efforts going forward.

I was also able to visit with the director of the Office of Crisis Management for the Agency, which will continue to play the lead role in responding to natural disasters and other incidents.  I toured the Emergency Operations Center and talked with the director and staff  to assure them that CORE will continue to work closely with this crucial office in the future.

Key consumer groups, including two organizations representing foodborne illness victims and their families, also shared their insights with me and my FDA colleagues.  Two of the members of these groups spoke movingly of the deaths of their children from contaminated food and how they vowed to use their experiences to improve food safety for all American families.

As a mother of four children, I listened and tried to imagine the grief they have experienced.  Having investigated numerous foodborne outbreaks at the State level, I have experienced the frustration of being unable to identify the “culprit”; or, when successful, wondering how food contamination could ever have occurred in this modern world; and wishing that the “lessons learned” from the outbreak could have been translated into effective preventive recommendations and policy.  After hearing their stories, the “why” of food safety has never been clearer for me.

This commitment to food safety was also the theme of a call with industry representatives who spoke of the critical knowledge they can bring to bear in times of a foodborne illness outbreak.

For instance, two of the large trade associations representing the produce industry spoke about the wealth of information they have on produce and how they want to make certain FDA has access to and is able use this valuable data they have before, during and after an outbreak.

A large group representing retailers echoed this commitment to sharing information throughout our conversation, as well as making certain the industry’s “knowledge factor” is used in outbreak response.  We all reiterated the importance “of learning in retrospect” from outbreaks, and I shared with them that this was a lesson I had learned early on in my work in preventive medicine.

Meetings with new colleagues at FDA and on the calls with some of our stakeholders also gave me an opportunity to reflect on the historic shift taking place in food safety.  The FDA Food Safety Modernization Act squarely puts in place the public health principle of prevention as the foundation of all our food safety efforts.

It’s an historic shift not only for those of us in government, but also for industry.  And prevention is key for all of us, as Commissioner Hamburg and I agreed when I had the opportunity to chat with her the next morning.  It is especially important in today’s world, where our food supply is global as well as local.

Bracing and exhilarating would be my words for that first day – just like that Gulf of Maine.  And it’s what I was hoping for.

Dr. Kathleen F. Gensheimer, M.D., M.P.H.,
Chief Medical Officer
Outbreak Director

The best way to get into the Gulf of Maine in August is to jump feet first.

New Transparency Report Focuses on Enforcement Data

October 3, 2011 13 comments

Today, FDA is releasing 8 new draft proposals in a report entitled “Food and Drug Administration Transparency Initiative:  Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data.”

These draft proposals are focused on making FDA’s compliance and enforcement data more accessible and user-friendly, and they are part of our ongoing efforts to increase the transparency of FDA’s operations and decision-making.

In developing these draft proposals, FDA met with the Environmental Protection Agency (EPA) and the Department of Labor (DOL), both of which have well-developed and well-regarded enforcement data websites ( and, respectively).  At these meetings, EPA and DOL shared their insights to help us learn from, and build upon, their experiences.  Like FDA, EPA and DOL recognize that transparency can drive good behavior and promote regulatory compliance.

We invite the public to comment on FDA’s draft proposals, and to review the Agency’s progress in implementing other action items and draft proposals related to the Transparency Initiative at:

Lisa M. Dwyer, J.D.

Senior Policy Advisor and Transparency Initiative Coordinator

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