FDA and Texas Join Forces in Immediate Response to Oil Spill

By: Dennis Baker

There’s never a good outcome after ships collide. But after a March 22, 2014 accident in which a barge and a ship collided in the Houston Ship Channel, a collaborative, flexible response led by FDA and its state partners prevented a catastrophe. Spilled into the waterway were 167,800 gallons of bunker fuel, a waste product from traditional fuel oil processing that is a cross between a solid and a liquid. What followed the collision was an immediate and coordinated federal-state response, underscoring the collaborative flexibility of FDA.

Dennis BakerFDA’s Dallas District Office, Office of Emergency Operations, and the Texas Department of State Health Services (DSHS) began working together within 24 hours of the spill. Trained personnel from FDA’s Office of Regulatory Affairs’ Southwest Region and Dallas District were communicating daily with state public health officials and investigating the risks to public health. A Southwest Region shellfish specialist, Chris Brooks, was part of a team monitoring reports from DSHS’ Seafood Safety Group regarding the condition of Galveston Bay, into which the channel flows to the south.

As a result of such close and early collaboration following the spill, the DSHS and the Dallas District Office jointly activated the Texas Rapid Response Team (RRT) on March 27 for information and coordination purposes, and Incident Commanders were appointed. Then, a very quick response unfolded.

  • More than 70 seafood firms were identified by DSHS—with the list growing to 103 firms—and visits were scheduled to ensure their products were not contaminated.
  • A state-wide consumer alert was broadcast to inform the public about the spill and dockside deliveries of seafood were monitored throughout the area.
  • A massive oil recovery operation swung into place as the oil slick moved southward toward Matagorda Bay. Much of the bunker fuel spilled was ultimately captured by spill containment equipment.
  • The state issued a public consumption advisory recommending that people not eat fish, crabs or shrimp from the Galveston and Matagorda bays.
  • The DSHS contacted licensed seafood firms from Beaumont to Corpus Christi, an expanse of some 300 miles, and advised them to review their HACCP (Hazard Analysis and Critical Control Points) plan provisions for chemical contaminants. The firms were also encouraged to strengthen their dockside receipt procedures that include visual and organoleptic (taste, color, odor and feel) exams prior to accepting seafood.

This is but a snapshot of the mechanics of a successful federal-state collaborative effort, an immediate response to protect public health.

Learn more about FDA’s Office of Regulatory Affairs.

Dennis Baker is FDA’s Regional Food and Drug Director, Office of Regulatory Affairs

Marsha Henderson Leads Programs to Improve Health Outcomes for Women

By: Kimberly A Thomas, MPH

Kimberly ThomasI have worked with many clinicians and researchers whose dedicated efforts have helped to improve the health care women receive. FDA’s Marsha Henderson stands out among this distinguished group. For over 30 years, Marsha has led research and educational programs that help improve medical treatments for women and provide women with the resources they need to make informed health decisions.

For these efforts, Marsha was recently awarded the first Dr. Estelle Ramey Award for Women’s Health Leadership from the Society for Women’s Health Research. This award was created to recognize leaders like Dr. Ramey who demonstrate exemplary leadership in women’s health and a commitment to the study of the impact of sex differences on health.

Marsha was honored for her history of serving as a champion for women’s health, and for her leadership of FDA’s Office of Women’s Health. As the assistant commissioner for women’s health, Marsha directs research that helps FDA better understand how sex differences affect the safety and effectiveness of medical treatments.  At FDA, Marsha has also developed outreach programs that make sure that women from diverse communities have access to easy-to-read FDA health and safety information.

Marsha Henderson with award

Marsha B. Henderson, FDA Assistant Commissioner for Women’s Health, with FDA Commissioner Margaret A. Hamburg, MD (left) and Phyllis Greenberger, President & CEO of the Society for Women’s Health Research (right).

When I first came to the FDA in 2004, Marsha immediately showed me how the work we do at FDA can have a positive impact on women’s lives. Her leadership motivated me to find new ways to promote scientific discussion and expand educational outreach.

When Marsha accepted her award she not only acknowledged the tremendous personal honor, but she also recognized all of the scientists, health educators, and general staff at FDA whose daily work helps to improve the outcome of medical treatments for women. Her comments demonstrated why she is so deserving of this leadership award. I congratulate her on this honor and thank her for distinguished career serving as a voice for all women.

Kimberly A Thomas, MPH, serves as a senior advisor for communication and outreach in FDA’s Office of Women’s Health.

Women Scientists at FDA: A Legacy to be Proud Of

By: Suzanne Junod, Ph.D.

This is National Women’s History Month, a good time to reflect on FDA’s history of advancing women as scientists and health professionals. This tradition began with FDA’s predecessor in the late 19th and early 20th centuries, the Bureau of Chemistry in the Department of Agriculture. Several early female FDA scientists came out of the University of Pennsylvania, one of the first universities in the country to offer women chemistry degrees in the late 19th century.

Suzanne JunodHarvey Wiley, known as the Father of the 1906 Pure Food and Drugs Act and its “crusading chemist,” hired FDA’s first female laboratory chief. When his superiors found out that the “M. E. Pennington” he had selected to head a research laboratory was actually Mary Engles Pennington, he successfully argued that since she had received the top score on the Civil Service exam, he had no grounds on which to refuse her the position.  His argument carried the day.

Frances Kelsey, who had earned both an M.D. and a Ph.D. in pharmacology, was hired by FDA in 1960 as a medical officer. She came into the agency with top scientific credentials and a strong research background. In part, it was her experience with animal research that led her to question the effects of the drug thalidomide on fetal animals when that drug was submitted for FDA review. She had still not received a satisfactory answer to that question when the dangers of thalidomide became known and it was discovered to be a potent teratogen, an agent that can lead to birth defects. Thalidomide was never approved for marketing in the U.S.

FDA’s first women field inspectors, in contrast, were hired only after President Lyndon Johnson declared that the federal government would lead the way in implementing the 1964 Civil Rights Act. Imogene Gollinger, the first woman hired, had a degree from New York University and experience as a science teacher. She recognized that she was given the “opportunity of a lifetime” and happily reported to FDA wearing white gloves and a hat, which were immediately exchanged for standard-issue coveralls.

The concerns about women being able to keep up with the men proved to be misplaced. Gollinger was teased for buying a shopping cart to carry her heavy bag of inspector’s equipment, but she soon noticed men using them as well. While women willingly did the heavy and dirty field work, such as climbing into boxcars to obtain grain samples, they were increasingly drawn to investigative work involving piecing together data rather than simply gathering samples for analysis. For the female inspectors, compliance activities soon began to gain parity with traditional field sampling in FDA’s field operation.

Today, women make up approximately 59 percent of FDA’s work force, all of whom are involved in protecting and promoting public health. This is a legacy to be proud of as we celebrate women’s history.

Suzanne Junod, Ph.D., is an Historian at FDA.

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What’s new in the FDA’s 2015 budget?

By: William Tootle

A few days ago, President Obama released his Fiscal Year 2015 Budget Message to Congress, which included a high-level summary of his proposed funding for the FDA. Today the White House is out with the full budget, complete with all of the nitty gritty details.

William TootleAlthough these budgetary times are difficult, the FDA received some good financial news. The president is requesting a $4.7 billion budget for FDA, an 8.1 percent increase over the 2014 budget that Congress passed earlier this year.

For ease in discussing a budget of such scope, we typically group budgetary line items into a few large categories. This year our categories are medical product safety (which also includes our premarket review activities) and food safety (which also includes cosmetics).

Most of the $61 million increase for medical product safety comes from increases that were written into the statute when Congress authorized each of the five-year user fee programs.

One new line item in the budget is $25 million to strengthen oversight of the pharmacy compounding industry. In 2012 there was a fungal meningitis outbreak that killed 64 people and infected over 750 others in 20 states. This outbreak was shown to be the result of compounded drugs – the combination of two or more drugs to create a custom medication – that were created in unsafe conditions. To better protect the American people, FDA stepped up activities within available resources and Congress passed the Drug Quality and Security Act, giving us new responsibilities and authorities, but without commensurate resources. The President’s proposed 2015 budget doesn’t provide FDA with a $25 million increase to cover the agency’s pharmacy compounding activities. The money is coming from trims “on the margin” to other portions of our medical product programs.

The food safety portion of the budget includes $263 million in increased funding — including $253 million to implement the landmark Food Safety Modernization Act or FSMA. That 2011 law provided FDA with the authorities and mandates to build a modern domestic and imported food safety system designed to prevent rather than react to food-borne illness. Every year, contaminated food sickens about 48 million Americans and kills about 3,000.

FDA estimated in 2012 that it would need $400 million to $450 million to implement FSMA. Since then, the agency has received $78 million and issued proposed rules for all seven of the foundational provisions of FSMA.

Most of the $253 million proposed for FY 2015 would come from new user fees for imported foods, imposed on the industry. It’s worth noting that with current resources, we will still be able to issue the rules, but we won’t be able to effectively implement them and improve food safety without new resources to retrain inspectors, provide guidance and technical assistance to industry, partner with state agencies and build the modern import safety system Congress mandated.

The budget contains one final broad category of note, promoting the development of products that can be used to prevent or protect the public from bioterrorism. These medical countermeasures promote readiness against deliberate and naturally occurring public health threats. The FY 2015 budget includes $25 million for this initiative, the same as in FY 2014.

The FDA delivers significant results that help Americans every day in many different ways. FDA’s drug approval system continues to lead the world in both quality and speed. The agency approved 27 drugs that are entirely new to medicine in 2013, including advances in the treatment of rare forms of cancer and a virtual cure for Hepatitis C. The FDA approved a new flu vaccine, and a bird flu vaccine to be reserved in case of an outbreak. In addition to new drug approvals, the FDA has reduced the time it takes to review new medical devices. And the agency is promoting greater safety of cosmetic products. Finally, the FDA has made progress in carrying out new tobacco control legislation.

Americans rely on the FDA to keep their food and medical products safe and effective. The Fiscal Year 2015 budget contains the blueprint for how the FDA plans to accomplish this mission. We invite you to follow this link to peruse the details of the FDA budget of greatest interest to you.

William Tootle is Director of FDA’s Office of Budget

Honoring African American History by Increasing Access to Information Protecting and Promoting Your Health

By: Walter Harris

African-American History Month offers the opportunity to reflect on the contributions of African Americans in various ways, both in our local communities and on a national scale. 

Walter HarrisWe should also use this month of observance to note the public health disparities that continue in underrepresented and underserved communities.  Current CDC health statistics highlight poorer health outcomes for the African American, American Indian and Alaska Native, Asian American, Hispanic American, Native Hawaiian, and Pacific Islander communities. 

FDA’s Office of Minority Health (OMH), established in 2010 as a mandate of the Affordable Care Act, works to reduce racial and ethnic health disparities and to support achieving the highest standard of health for all.  A key effort to advance this mission is to promote effective communication and the dissemination of information to the public, particularly underserved, vulnerable populations. 

FDA’s website has a wealth of resources to help minority communities use safe medicines, foods, and other products the Agency regulates.  Whether you are a patient, student, health professional or caregiver, reading in English or Spanish, our website has resources to help you stay informed and stay healthy. 

We are continually working to improve user experience on FDA.gov.  We recently launched the mobile version, as our increasingly mobile stakeholders and workforce require creative approaches to keep our data and systems accessible on mobile platforms. We are also working to significantly improve the search capabilities on the website, as well as maintaining Section 508 compliance to ensure that www.FDA.gov content is accessible to people with disabilities. OMH also works to improve and strengthen the research and evaluation of subgroup demographic data associations with race and ethnicity, particularly how data is represented in clinical trial participation, safety and effectiveness data.  As a participant in FDA’s Data Standards Council, OMH helps to coordinate the evaluation, development, maintenance, and adoption of health and regulatory data standards for race and ethnicity to ensure that common data standards are used throughout the agency. 

FDA’s Office of Information Management and Technology is engaged in various ways to improve the availability of data for consumers, researchers, developers, and industry.  More than 80 resources are currently indexed publicly, many updated daily, including adverse drug events, reports involving medical devices, searchable listings of over-the-counter tests cleared or approved by the FDA, and a database of accredited mammography facilities. 

Our goal is to increase the transparency of FDA data to the public through the openFDA initiative, which is being run by the newly-established Office of Informatics and Technology Innovation. We plan to provide access to multiple high-value structured data sets to consumers, including the mobile app and software developer community, starting in Summer 2014.

FDA believes that access to this data will further the Agency’s regulatory mission and, most importantly, will help inform minority and underserved populations – as well as  the general population – on ways to improve their health. In support of this goal, we must break many of the traditional technology infrastructure barriers by implementing cloud technologies to better support the exponential growth of data we are managing. We are also leveraging this ingenuity to address, for example, analyzing and sharing large amounts of information such as applying Next Generation Sequencing for generating, analyzing, reviewing, and sharing genetic information.

I encourage all of us to commemorate this month by not only reflecting on the drive and inspirational spirit of past and present African Americans, but to also taking the time to think of how we can apply that same drive and spirit to our mission of protecting and promoting public health. 

Walter Harris is Deputy Commissioner for Operations and Acting Chief Information Officer, Food and Drug Administration

FDA.gov: Search Enhancements Mean More Satisfied Visitors

By: Chris Mulieri

In 2013, the Web and Digital Media team at FDA set two very challenging goals for FDA.gov: launch a mobile version of our website and improve visitor satisfaction when searching for information on our website. In my last blog post, FDA Takes a Responsive Approach to Mobile Web, I described how we applied best practices in web design and development to meet the needs of our mobile visitors – who now represent more than 25 percent of visitors to the site.

Chris MulieriI want to share how we implemented changes that resulted in better search results on FDA.gov – and more satisfied visitors.

Why Focus on Search?

Like many other government agencies, we use a customer satisfaction survey, ForeSee, to measure our visitors’ experiences with our website. The data from this survey and the write-in comments from visitors help us identify and address their needs.

Based on this information, we first “refreshed” the FDA website to improve the overall site navigation and usability, as our visitors requested. The next important area to address, according to the data, was the search function on FDA.gov.

Recipe for a Better Search

What does it take to provide a better search experience for visitors? It requires a lot more than just putting a search box on a site and calling it a day! There are many ingredients that go into the search function on a web site, and enhancing ours required several collaborative programs involving our FDA.gov web staff, the web staff for each of our centers and program offices, and our Office of Information Management.

Together we targeted three areas for improvement:

  • Adding search filters: This was the search improvement most frequently requested by our visitors. They wanted to be able to limit their search results by product area, such as drugs or food, or by type of document, such as warning letters.
  • Archiving older pages: Sometimes, a search on FDA.gov would yield pages of links to documents from years ago, which visitors found frustrating. Thanks to a new archiving approach, we were able to remove thousands of these older pages from the main search. The good news is that those pages are still available by searching the FDA archive.
  • Improving search usability: We updated both our search page and our search results page based on the latest best practices in web usability.

The Result: Increased Satisfaction

After we implemented each of these improvements, we monitored the customer satisfaction data for changes. From late 2012 to the end of 2013, the satisfaction score for the search experience increased from 69 to 78 and the overall site satisfaction increased from 70 to 78.

Web Search Chart

What do these scores mean? In short, our visitors were much more satisfied with our search tools and the site as a whole. According to Foresee, FDA.gov had the third largest increase in satisfaction among government agencies in 2013. We also have one of the highest levels of overall satisfaction among regulatory agency websites.

In the end, though, the goal of our website improvements is not a higher score here or a higher ranking there. Our goal is to meet the needs of our visitors – consumers, patients, health professionals, and companies – who rely on FDA.gov as an authoritative source of information about the products we regulate.

Looking to the Future

In 2014, our goal is to continue building on these recent improvements to ensure we are providing the information our users need – when and where they need it.  We are continuing to develop additional mobile friendly content, and these pages will be available soon. In addition, we continue to monitor the feedback we receive through our satisfaction survey, and when appropriate, we are prepared to act on this feedback to ensure we are providing the experience you deserve.   

Learn More about FDA’s Web Enhancements

Chris Mulieri is the director of web and digital media for the Food and Drug Administration

We Moved Forward on Many Fronts This Year

By: Margaret A. Hamburg, M.D.

At the FDA, the agency that I’ve had the privilege to lead for the past five years, I am gratified to report that we have a lot to be proud of this year. In fact, this past year’s accomplishments on behalf of public health have been as substantial as any in FDA’s recent history.

Margaret Hamburg, M.D.We moved significantly forward, for example, in creating a system that will reduce foodborne illness, approving novel medical products in cutting-edge areas of science, and continuing to develop our new tobacco control program. We worked successfully with Congress and with regulated industry to reach agreement on a number of difficult issues, while continuing to use the law to the full extent possible to protect consumers and advance public health.

While there were many significant actions and events to recognize, below are some of the highlights of 2013.

In the foods area, there were many new actions this year that will have a long-standing impact on improving our food supply for consumers. Throughout the year we have been proposing new rules to reach the goals set forth by the FDA Food Safety Modernization Act (FSMA). These science-based standards will help ensure the safety of all foods produced for our market, whether they come from the U.S. or from other countries.

We also took important steps towards reducing artery-clogging trans fat in processed foods, and understanding the health impact of arsenic in rice. With a final rule that defines when baked goods, pastas and other foods can be considered free of gluten, people with celiac disease can have confidence in foods labeled “gluten free.” And we are studying whether adding caffeine to foods may have an effect on the health of young people and others.

There have likewise been many accomplishments in advancing the safety and effectiveness of medical products. We worked closely with Congress on the recently enacted Drug Quality and Security Act, which contains important provisions relating to the oversight of human drug compounding. The law also has provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.

Using tools provided by last year’s landmark Food and Drug Administration Safety and Innovation Act (FDASIA), we are continuing to improve the speed and efficiency of medical product reviews, including those involving low-cost, high quality generic drugs and innovative new medical devices. The average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010. The percentage of pre-market approval applications that we approve has increased since then, after steadily decreasing each year since 2004.

We launched a powerful new tool to accelerate the development and review of “breakthrough therapies,” allowing FDA to expedite development of a drug or biologic (such as a vaccine) if preliminary clinical evidence indicates that it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. This offers real opportunities to get promising drugs more quickly to patients who need them. In fact, using this new approach, FDA recently approved two advanced treatments for rare types of cancer and one for hepatitis C. We have also strengthened efforts to ensure product quality, increased protection of the drug supply chain, and reduced drug shortages.

We confronted the growing misuse of powerful opioid pain relievers by advising manufacturers on how to make these drugs harder to abuse with formulations that are more difficult to crush for inhalation or dissolve for injection. And we recommended that hydrocodone combination products be subject to stricter controls to help prevent abuse. 

We took an important step towards fighting the development of antibiotic-resistant bacteria by implementing a voluntary plan to phase out the use of antibiotics to enhance the growth of food-producing animals, and to move any remaining therapeutic uses of these drugs under the oversight of a licensed veterinarian. So-called “production” use is considered a contributing factor in the development of bacteria that are resistant to the antibiotics used in human medical treatment.

In many areas of our work we are supporting the emerging field of personalized medicine. Advances in sequencing the human genome and greater understanding of the underlying mechanisms of disease, combined with increasingly powerful computers and other technologies, are making it possible to tailor medical treatments to the specific characteristics, needs, and preferences of individual patients.

Many cancer drugs today are increasingly used with companion diagnostic tests that can help determine whether a patient will respond to the drug based on the genetic characteristics of the patient’s tumor. In May, FDA approved two drugs and companion diagnostic testing for the treatment of certain melanoma patients with particular genetic mutations.

Advances in science and technology are also seen in the creation of new medical devices. For example, 3-D printing - the making of a three-dimensional solid object from a digital model – was once considered the wave of the future. But in February, FDA cleared for marketing a device created by 3-D printing – a plate used in a surgical repair of the skull that is built specifically for the individual patient.

While we have worked hard to get therapies to patients, we are at the same time using the tools available to us to remove unsafe and dangerous products from the market. In November, we used new enforcement tools provided by the food-safety law to act quickly in the face of a potential danger to public health presented by certain OxyElite Pro products. These supplements had been linked to dozens of cases of acute liver failure and hepatitis. After FDA took action, the manufacturer agreed to recall and destroy the supplements.

Finally, we made significant progress in implementing the letter and spirit of the Family Smoking Prevention and Tobacco Control Act. We have signed contracts with numerous state and local authorities to enforce the ban on the sale of tobacco to children and teens; conducted close to 240,000 inspections; and written more than 12,100 warning letters to retailers. And, in the first quarter of 2014 we will launch a public education campaign aimed at reducing the number of young people who use tobacco products.

All of us take great pride in the skill and vigor with which we overcame the year’s challenges and new demands. And so, as the year draws to a close, I extend my gratitude to the employees at the FDA who work tirelessly on behalf of the American public year in and year out. To all of our stakeholders, my heartfelt wishes for a joyous holiday season and a safe and healthy 2014.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration

A ‘Vision’ Worth Honoring

By: Heidi Marchand, PharmD

My office serves as a bridge between FDA and a wide range of health professional, patient, consumer, tribal and industry audiences. Among our top priorities is collaborating with public-health minded groups and individuals to help us better understand and respond to the needs of stakeholders.

Dr. Helene Clayton-Jeter accepts award

Dr. Helene Clayton-Jeter, front center, accepts the 2013 AOA Leadership in Public Health Award alongside her colleagues, Beth Fritsch - OHCA Deputy Director, at front left, Heidi Marchand - OHCA Assistant Commissioner, at front right, Dr. Michael Duenas - AOA Chief Public Health Officer, at back left, Matt Willette - AOA Assistant Director, Federal Government Relations, at back center, and Jon Hymes, AOA Director, at back right.

One such example is the work we’re doing with the American Optometric Association (AOA) and the Entertainment Industry Council (EIC) on the Decorative Contact Lens Campaign Project. The goal of this important work is to inform young people about the potential risks of using decorative contact lenses improperly.

These lenses change the appearance of the eyes to give them a “cool” look – like making them look like vampire or cat eyes. They could change the eye color. But they can cause serious eye damage if they’re not fitted by an optometrist or ophthalmologist. Failure to properly clean and care for the lenses could cause vision-threatening infections.

Recently, Helene Clayton-Jeter, O.D., Health Programs Coordinator, who leads the project for my office, was honored by AOA for her superlative work on this project. Dr. Clayton-Jeter, who for years was a practicing optometrist, was instrumental in providing valuable insights that helped shape this public health message.

Dr. Clayton-Jeter is the first recipient of the Leadership in Public Health Award, which AOA plans to give annually hereafter to a member optometrist who has provided innovative and far-reaching solutions to public health challenges, augmented the optometrist’s role in public health, and advanced the provision of health care services by optometrists to Americans.

The project is set to be launched next spring, just in time for spring breaks and end-of-school-year celebrations. This is a time when students are more likely to purchase and use decorative contact lenses. By reinforcing the importance of using these lenses only under the supervision of a health care professional, we hope the project will protect the health and preserve the vision of the many young people who are otherwise apt to use decorative lenses unsafely. Working closely with Dr. Clayton-Jeter on this project were the FDA’s Office of Communications and Center for Devices and Radiological Health, which regulates contact lenses.

While making the formal presentation, Michael Dueñas, O.D., AOA’s Chief Public Health Officer, said this award is a testimony to Dr. Clayton-Jeter’s personal commitment and dedicated work toward the advancement of innovative and effective solutions in safeguarding the health of the American people.

I am very proud of Dr. Clayton-Jeter’s achievements and the integrity that she brings to her work every day at FDA.

Heidi Marchand, PharmD, is FDA’s Assistant Commissioner in FDA’s Office of Health and Constituent Affairs

FDA Takes a Responsive Approach to Mobile Web

By: Chris Mulieri

Since January 1, over 30 million visitors have come to FDA’s website. We know that they come to FDA.gov to get reliable and up-to-date information on everything from food and drug recalls to medical product alerts to regulations and guidance for industry…and the list goes on.

We also know that an increasing number of our visitors use mobile devices to get this information. In the last year alone, the number of mobile visits to FDA.gov has nearly doubled, and now 25 percent of our visitors use a tablet or smartphone to access the site.

Our Visitors Come First

As director of web and digital media for the FDA, I lead a team that is committed to providing a positive experience for visitors to FDA.gov, including our mobile visitors. We are also responsible for supporting the Digital Government Strategy, issued by the White House, which calls for federal agencies to provide government information on demand and on any device.

In plain English, that means that we need to provide a single FDA.gov site that’s available anytime, anywhere, on any device.

To meet the needs of our mobile visitors without creating a separate mobile website, we turned to a proven web development approach called responsive design. This approach uses special code to ensure that web content is easy to read and scroll across a wide range of devices, from desktop computers to mobile phones. Since the first of the year, mobile-friendly responsive designs have been implemented successfully on a number of large non-government websites, such as NYTimes.com and NPR.org. And now, on FDA.gov as well.

Check Out FDA.gov on Mobile

We are excited to announce that our first responsive pages on FDA.gov launched on November 15. If you are using a smartphone or tablet, go to FDA.gov and check it out. You’ll see our most popular content, such as recalls, news, and safety alerts, is now formatted to fit your screen. We’ve also made it easier for mobile visitors to tell us about a problem with the products that FDA regulates, such as food, drugs, medical devices, and animal food and drugs.

This is just the beginning. In keeping with best practices in web design, we are taking an iterative approach to mobile on FDA.gov. In other words, we will apply the lessons learned from our visitors’ experiences to share more mobile friendly content as it becomes available.

Our ultimate goal is to create one website that will provide a quality experience for all visitors who seek information that will benefit their health and safety.

Chris Mulieri is the director of web and digital media for the Food and Drug Administration

On Farms and in Labs, FDA and Partners Are Working to Get Answers on Arsenic in Rice

By: Margaret A. Hamburg, M.D.

This week, my colleagues and I traveled to California to learn more, first-hand, about the presence of arsenic in rice.

FDA Commissioner Margaret Hamburg and Deputy FDA Commissioner for Foods and Veterinary Medicine Michael Taylor, center, don hip waders to go out into the rice fields at Lundberg Family Farms in Richvale, Calif. At left is Bryce Lundberg, the farms' vice president of agriculture, and at right is Mike Denny, vice president of farming operations.

This grain, like other foods, contains traces of arsenic, a chemical element found in water, air and soil. However, rice plants absorb more arsenic than most other crop plants. FDA has been monitoring arsenic levels in foods, including rice, for decades.

On Wednesday, Sept. 4, we toured a research facility in which scientists are working to find ways to improve the quality and safety of rice. And we visited the historic farming community of Richvale — a short drive north of Sacramento — known as the birthplace of California rice.

In each of these places I saw a true commitment to public health and a shared goal of ensuring that any risk is minimized so that people around the world can continue to eat rice and rice products as part of a varied diet.

Today, FDA released the results of tests performed on a total of more than 1,300 samples of rice and rice products. What we found was that the levels of inorganic arsenic are well below the levels that would result in any immediate or short-term health risks. This information will now be considered by FDA in looking at the potential long-term health effects associated with the consumption of arsenic in rice and rice products.

Our visit to California, at the invitation of the rice industry – including the USA Rice Federation – was FDA’s third fact-finding visit to rice-producing states, the earlier trips being to Arkansas and Missouri. My traveling companions included Michael Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, and Andy Hammond, regional director of the U.S. Department of Agriculture’s Agricultural Research Service (ARS).

Our first stop on Wednesday was at the Rice Experiment Station in Biggs operated by the California Cooperative Rice Research Foundation. Research at the station is funded in large part by assessments on rice growers and involves close collaboration with experts at the University of California/Davis and ARS.

Touring the station’s research fields gave us a sense of the determination by all involved in this work, including industry, to better understand how arsenic gets into rice and what growing and processing strategies might be employed to reduce arsenic levels.

That afternoon we visited two multi-generation family farms in Richvale. Lyle Job and his family have been farming their land for more than 30 years. At the Lundberg Family Farms, in business since 1937, we learned about the different approaches of organic rice farmers.

These farmers take enormous pride in their work. They told us about the soil and climate conditions that make their land ideal to grow rice. At the Job farm, we climbed up into a huge harvester to see how it operates. At the Lundberg farm, we put on hip boots and waded out into flooded fields.

Standing beside these farmers, I was struck by their commitment to making the best product possible and the intensity of their desire to help us understand the challenges they face. Rice is not just a commodity to them; it’s their way of life.

Our last stop, on Thursday, Sept. 5, was to FDA’s laboratory in Alameda, where hundreds of rice samples were tested using a process called “speciation.” FDA scientists developed the speciation method used to measuring total arsenic levels, but most importantly to measure both the organic and the more toxic inorganic forms of arsenic.

So what does this all mean right now? As a mother I can imagine that many of you are asking yourself, “Should I be feeding it to my children?” Our best advice – consistent with that given by the American Academy of Pediatrics – is to eat a well-balanced diet that includes a variety of grains.

We don’t have all the answers yet, but we’re working on it. In collaboration with farmers, industry, academia and other public health agencies, we are doing everything possible to determine if the levels of arsenic in rice pose a long-term health risk and, if so, what can be done to reduce that risk.

The presence of arsenic in rice is a global health issue. The answers we seek will ultimately help protect consumers all over the world.

For more photos of our tour, visit Flickr.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration