Archive for the ‘Transparency Posts’ Category

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

October 6, 2011 52 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

FDA Tells Farmers: We need to learn from you

August 20, 2011 58 comments

Michael R. Taylor, FDA and Bob Nolan, Deer Run FarmsMichael R. Taylor, FDA and Bob Nolan, Deer Run Farms
Photo taken by Erica Pomeroy

Last week, farmers from across the North and South forks of Suffolk county Long Island showed a group of us from the U.S. Departments of Agriculture and Health and Human Services, the Food and Drug Administration (FDA), and the New York State Department of Agriculture and Markets the incredible diversity of their farms and the challenges FDA faces in writing a “produce safety” rule.

Bob Nolan, who farms 30 acres with his son and uncle, invited us because he heard that we had walked the rows of other fresh fruit and vegetable farms across the country.  In fact, this was the 14th state we visited in the last year or so.  We have seen the orchards of Oregon, the vast vegetable fields of California, Amish farms in Ohio, irrigation-dependent produce operations in Texas, vegetable farms in Delaware, North Carolina family farms, and Florida tomato fields to name just a few.

And each time, we have come away with new insights from the farmers and their families about how they are already addressing produce safety concerns, what they expect from an FDA rule, and the challenges of maintaining their way of life.

Our Long Island tour was a microcosm of the diversity we have seen across the country.  Organized by Cornell extension agent Sandy Menasha and Long Island Farm Bureau executive director Joe Gergela, the tour of seven farms ranged from small to large, conventional to organic, first-generation farmer to twelfth generation.

Let’s face it, the first question a federal official gets asked on a farm is as blunt as the summer day is long: Why are you here?  Mike Taylor, the FDA deputy commissioner for foods, has a pretty good answer: If we’re going to get this produce safety rule right, we need to learn from you.

That’s it in a nutshell.  While FDA and its colleagues at USDA bring to the table scientific and public health expertise, we all know that farms are very much the real world of soil, air and water open to the elements 24/7 and worked by humans and animals.  Farmers can inform us from their experience and practices.

Just see the different perspectives shared with us last week: the first-generation organic farm of the Garden of Eve; the 225-acre Ed Zilnicki and Sons’ potato farm; Nolan’s 30-acre Deer Farms devoted to leafy greens; the “agritainment” and “u-pick” farms like Hank’s Pumpkin Town, Harbes’ Family Farm, and the Milk Pail; and the farm stand run by Jim and Jennifer Pike.

And we got to hear loud and clear what the farmers expect from the FDA.  “I can’t hire a food safety guy. I am the food safety guy,” Bob Nolan said.  Hank Kraszewski wants the produce safety rule to be “crystal clear.”  Tell farmers straight out, “What do I have to do,” he said.  Record-keeping can’t become burdensome for small farmers like themselves, Eve Kaplan-Walbrecht and Jim Pike told us.

Farmers are also thirsty to learn more.  Horse manure is a time-honored soil amendment for the sandy fields of Long Island.  How can they apply it safely, they want to know.

And, while we heard that while farmers get it about food safety, they also want us to get it about the economic realities they face.  Several had struggled in the ‘90s when wholesale potato farming became less profitable and they moved to other commodities and on-farm retail sales.

Successful produce safety is possible if farmers and food safety officials work together, listening to each other and learning from each other.

Sharon Natanblut, Senior Advisor to the Deputy Commissioner for Foods, FDA

Fostering Innovation Through Better Science

August 17, 2011 21 comments

Science is the backbone of everything we do at FDA.  Which is why today’s release of the agency’s Strategic Plan for Regulatory Science is a significant next step in the agency’s Regulatory Science Initiative, originally announced in October, 2010.  We are releasing the plan along with a podcast and a consumer article to make it easier for everyone to join this conversation about regulatory science and understand what this plan really means.

“As new discoveries yield increasingly complex products,” says FDA Commissioner Margaret A. Hamburg, M.D. “this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy.  It positions us to foster innovation through better science without compromising our high safety standard.”

This plan calls for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy and security.  It recognizes the important role the agency must play in fostering innovations in the marketplace today to address the public health challenges of tomorrow.                       

All around us we see evidence that new technologies are creating unprecedented opportunities to prevent and cure disease as well as to grow our high tech economy.  As my colleague and FDA’s Chief Scientist Dr. Jesse Goodman says:  “This plan will help turn advances in science into products that benefit people, and help FDA assure that happens more quickly and safely.  It is win-win-win, because it will help the public, the agency and developers of new products.” 

This plan signals clearly the agency’s intent to work collaboratively with our colleagues in academia and industry to enhance the process for developing and evaluating promising new products and novel materials emerging from fields such as cell therapies, tissue engineering, genomics and personalized medicine, and through use of advanced computing and information technology.  

As we move forward, we welcome ideas and comments.  We are inviting our partners, domestic and international, and the public to join the conversation as we take the steps necessary to advance and target the best regulatory science to help meet the nation’s highest public health priorities and medical needs.

Thank you.

Vicki Seyfert-Margolis

Check It Out: Newly Redesigned FDA-TRACK Dashboard Pages

July 26, 2011 47 comments

FDA’s performance management system, FDA-TRACK, allows the public to follow the agency’s progress on a range of measures (see April 7 blog  post).

We redesigned FDA-TRACK!  It has been a little over one year since the launch of the FDA-TRACK website.  After collecting web traffic data during this time, we decided to make some changes to the dashboard pages in hopes of improving your experience.  The changes include:

Check out these before and after shots:


Before screenshot of FDA Track showing data organized within many tables


Screenshot of updated FDA-TRACK design.

Please visit any of the FDA-TRACK dashboard pages to see these changes.


The US and Mexico Share Approaches on Food Safety

July 11, 2011 77 comments

In June, I had the opportunity to lead a delegation of food safety officials from the Food and Drug Administration to meet with our Mexican counterparts. The trip was part of a larger, proactive strategy to reach out to stakeholders, both domestic and foreign, to explain the background and implementation strategies for the new Food Safety Modernization Act (FSMA) and importantly, to listen to issues raised by stakeholders. Following Canada, Mexico is the largest exporter of foods to the United States. It was an exciting opportunity to meet with Mexican officials, not only to provide outreach on our new law, but also to gain a better understanding of Mexican food safety interests and challenges, and to identify areas for collaboration to further ensure the safety of foods for our respective populations.

Throughout the discussions, our team was impressed with the level of agreement on overarching principles and strategies to assure foods are safe for our respective populations. Like us, Mexico has embraced food safety as a priority and is in the process of establishing new mandatory food safety regulations, including produce safety regulations. Some of the key themes that were emphasized throughout our discussions were consumer protection, science- based standards, the need for importer controls, the importance and role of third- party certification. Throughout our discussions, I felt that I was indeed hearing many of the principles embodied in FSMA, such as the importance of prevention, the need to establish strong partnerships, a robust import program, and an effective program of risk-based inspections. In addition, there was a common recognition of the importance of making sure new regulations consider trade impacts, and the importance of transparency in rulemaking. Our strong alignment on key principles was both gratifying and extremely encouraging.

We had a whirlwind schedule. Highlights are as follows:

Our FDA delegation was welcomed to Mexico by Honorable John D. Feeley, U.S. Chargé d’Affaires to Mexico, and Mr. James H. Williams, Acting Deputy Chief of Mission, at the U.S. Embassy in Mexico City. The FDA delegation also met with representatives of U.S. agencies at the U.S. embassy in Mexico from Foreign Agricultural Services, Foreign Commercial Service, Animal and Plant Health Inspection Service; and the State Department Economic Section. Embassy officials were very helpful in sharing their perspectives on FSMA and potential cooperative activities with Mexico. Last year, FDA opened its new office in Mexico City. We were delighted to see our staff integrated into US Embassy activities and representing the agency in a stellar manner with our regulatory counterparts.

Next, we had an informative meeting with Mexican Government agencies involved in food safety. Mexican Government agencies represented included: Secretariat of Agriculture – Secretaría de Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación / Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria (SENASICA); Secretariat of Health – Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS); Secretariat of Economy – Secretaria de Economía; Secretariat of Foreign Affairs – Secretaria de Relaciones Exteriores; and Secretariat of the Environment- Ambiente y Recursos Naturales (which is the agency in charge of CONAGUA which plays an essential role in helping to ensure the quality of water used in farming and agriculture). Later in the day, we had a discussion with SENASICA to learn more and discuss their latest proposal for the revision of the FDA-SENASICA Cantaloupe MOU, which is scheduled to expire in October, 28, 2011. The parties agreed to further discuss possible opportunities for the enhancement of the MOU including possible enhanced collaboration on technical and operational protocols, exchange of regulatory information, as well as on food safety research.

We had the pleasure of having lunch with representatives of Mexican academic institutions including: National Autonomous University of Mexico (Universidad Nacional Autónoma de México); National Polytechnic Institute (National Instituto Politecnico); The Autonomous University of Puebla (Benemérita Universidad Autónoma de Puebla); and the Postgraduate College (Colegio de Postgraduados). The luncheon emphasized the important contribution of academia to the regulatory process on innovation and research, not only in food safety science but also in pubic health, political science, and business management.

One of the most dynamic parts of the day was a joint FDA, SENASICA and COFEPRIS roundtable with Mexican industry and trade organizations. Industry and trade expressed their concerns, views, and suggestions on FSMA. Participants discussed Mexico’s inspection protocols and FDA’s inspection procedures and import protocols at the border. We addressed questions related to produce safety preventive controls.

Following the meeting with industry, I participated in a press conference with senior officials from SENASICA and COFEPRIS and Mexican news media during which we were able to reinforce common messages on food safety.

We had a wonderful, productive day in Mexico. We acknowledged and indeed celebrated our common commitment to food safety.

Michael R. Taylor, Deputy Commissioner for Foods

Update on Retrospective Review of FDA Regulations

June 3, 2011 27 comments

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 goal of EO 13563 is to target rules already on the books to increase flexibility and remove regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules.

On May 26, in support of EO 13563, more than two dozen Federal agencies released plans that identified initiatives with the potential to eliminate tens of millions of hours in reporting burdens, and billions of dollars in regulatory costs.  FDA, as part of the Department of Health and Human Services (HHS), is included in the HHS Preliminary Plan for Retrospective Review of Existing Rules (HHS Plan), which can be seen at  The HHS Plan identifies regulations already being modified or streamlined and identifies additional candidates for further review.

The HHS Plan highlights the activities FDA is undertaking in support of EO 13563.  For example, we are reviewing the “Bar Code Rule” to assess the costs and benefits associated with it and to determine if the rule should be modified to take into account changes in technology that have occurred since the rule went into effect.  The Bar Code Rule requires certain human drug 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 right route of administration) is being given to the right patient at the right time.  Stay tuned for a solicitation of information on the Bar Code Rule. For further information about other FDA activities in support of EO 13563 see

As we go forward, we are very interested your input.  As I wrote in our April 26 blog, at, we do not operate in a vacuum and we value the input of all our stakeholders.   On April 27, 2011, we published a notice in the Federal Register requesting comment and supporting data on which, if any, of our existing rules are outmoded, ineffective, insufficient or excessively burdensome and thus be candidates for review.  Please review our Federal Register notice and the HHS plan and submit your comments to FDA by June 27, 2011 at!documentDetail;D=FDA-2011-N-0259-0001.  You can also submit comment on the HHS plan at

Thank you,


Leslie Kux, Assistant Commissioner for Policy (Acting)

New sources of FDA enforcement information posted

May 26, 2011 29 comments

Today, the FDA is implementing the first in a series of proposals to increase public understanding of the public health impact of FDA’s enforcement efforts, help inform companies’ efforts to comply with FDA requirements, increase company accountability to consumers and business partners, and help consumers make more informed decisions about the products they buy.

This action stems directly from the FDA Transparency Initiative, which Commissioner Margaret A. Hamburg, M.D. launched in 2009. The initiative is designed to examine all agency activities and consider ways to make them more transparent. After holding public meetings and inviting written comments, FDA issued its first report, proposing 21 actions to increase disclosures about agency activities.  Today, the agency is taking several steps to increase transparency related to its enforcement activities:

• Posting a summary of the most common inspectional observations of objectionable conditions or practices that are made during inspections.

• Providing a searchable database that includes the name and address of inspected facilities, the date(s) of inspection, type of FDA-regulated products involved, and final inspectional classification.

• Alerting the public in a consistent manner about enforcement actions, by issuing press at the beginning and the end of the process, unless confidentiality is necessary.

The FDA is also providing a new web page to house all of the agency’s key transparency activities related to enforcement so that these resources will be easier to find and use.

In the coming months, 3 additional enforcement-related transparency actions will be implemented. FDA will begin to disclose additional information about FDA evaluations of importers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall. FDA will also move forward on other proposals in the report.

Ann Witt
Transparency Coordinator

What needs fixing and how can we fix it?

April 26, 2011 56 comments

The FDA doesn’t regulate in a vacuum. We need to listen to all our stakeholders – the American people who we protect and the industries we regulate. One important way we do this is by a process called retrospective review of regulations.

So what does this mean? As part of a process begun by President Obama, the FDA today announced that we are formally asking for submissions on how to improve existing regulations. Retrospective reviews like this really help us focus on how we can improve our regulations and give us invaluable insights on how we, and those we regulate, can be more innovative and take advantage of innovation as we work to protect and promote the public health.

For FDA, review of regulations is grounded in straightforward principles. First, regulations should change with the times. Second, they should not impede innovation and, if possible, foster it. Third, the effort they call for (the burden or cost of complying) should be reasonable. Fourth, they should not be ineffective. In other words, regulations should make sense, and if they don’t, we should change, strengthen, clarify, streamline, or revoke them.

That’s where you come in.

We want to hear from you. Help us identify areas to focus and improve. Where are our regulations ineffective? Do our regulations address current public health challenges? Where do we need to update our regulations? Can we revise them in ways that makes them less burdensome without making them less effective? Where can we be more flexible? How we can put greater emphasis on innovative scientific approaches? Do we have regulatory requirements that are redundant, inconsistent or needlessly overlap?

We’re most interested in big ideas, ones that identify regulatory problems that have the greatest impact on the public health.

If you want to help us with this important task, you can learn more by visiting the Federal eRulemaking Portal and following the instructions for submitting comments.

We are looking forward to your suggestions. Thank you very much – Leslie

Leslie Kux

Assistant Commissioner for Policy (Acting)

FDA ‘Strategic Priorities 2011 – 2015’

April 20, 2011 70 comments

Today’s release of a strategic priorities document outlining the goals and strategies that the FDA and its 12,000 employees will pursue through 2015 marks a renewal of our commitment to creating a stronger, more effective agency.

Titled “Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century,” the 50-page document provides a vision of the FDA that includes:

  • a modernized field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their life cycles
  • an integrated global food safety system focused on prevention and improved nutrition
  • expanded efforts to meet the needs of special populations.

Senior staff from the FDA’s seven product and research centers and two major offices contributed to the document. A Federal Register notice that invited public input in October 2010 generated more than 200 comments that were considered for the final document.

The field of regulatory science and innovation is among five cross-cutting areas that will serve as strategic priorities at the agency during the next five years.

The FDA must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe, and effective products and life-saving therapies. This document sets forth our priorities for achieving that goal.

Thank you,

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs


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