Upcoming Event: FDA Webinar on Prescription Drug Shortages, September 30, at 11am ET.

September 28, 2011 47 comments

Do you know that in 2010 there were a record number of shortages of prescription drugs, and that in 2011, FDA continues to see an increasing number of shortages, especially those involving older sterile injectable drugs?

As part of FDA Basics, FDA is hosting a webinar where you can learn how the agency helps reduce the impact of drug shortages for patients and our nation’s health care system. Captain Valerie Jensen, R.Ph., Associate Director for FDA’s Center for Drug Evaluation and Research’s (CDER’s) Drug Shortage Program, will discuss the extent of the current drug shortage issue and the importance of communication among FDA, drug manufacturers, health professionals, and the public, in helping to reduce its impact on public health.

The free 30 minute webinar will be held Friday, September 30m, 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 the webinar.

FDA Tells Farmers: We need to learn from you

August 20, 2011 63 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 22 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 50 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 85 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 http://www.hhs.gov/open/recordsandreports/execorders/13563/draft/index.html.  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 http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm257692.htm

As we go forward, we are very interested your input.  As I wrote in our April 26 blog, at https://fdatransparencyblog.fda.gov/2011/04/26/what-needs-fixing-and-how-can-we-fix-it/, 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 http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0259-0001.  You can also submit comment on the HHS plan at http://www.hhs.gov/open/recordsandreports/execorders/13563/draft/index.html

Thank you,


Leslie Kux, Assistant Commissioner for Policy (Acting)

New sources of FDA enforcement information posted

May 26, 2011 35 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


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