Getting More Accurate Tobacco Information to Consumers

By: Margaret Hamburg, M.D.

Tobacco use is the leading preventable cause of disease and death in our country. And this Administration is committed to implementing strategies that will stop our nation’s youth from starting to use tobacco and also help adults to quit. Today we’re taking two critical steps forward that will help reduce harm from tobacco and tobacco products.

Margaret Hamburg, M.D.Americans will soon have more information on the chemicals found in certain tobacco products, reflecting FDA’s commitment to inform and protect the public. For the first time ever, tobacco companies will be required to report the quantity of harmful and potentially harmful constituents – HPHCs – that are in their products to the FDA.

The detailed information that we receive will help FDA determine how best to make science-based decisions to reduce the terrible toll of tobacco-related disease and death. We also hope that by having to disclose this information, industry will voluntarily start to make their products substantially less addictive and harmful.

We are also forging new territory as we seek to ensure that tobacco companies provide accurate information and will not be able to mislead American consumers, especially by making it sound like certain products are less risky than they are. The landmark Family Smoking Prevention and Tobacco Control Act signed by President Obama gives FDA the authority to ensure the claims for tobacco products marketed to reduce risk or exposure, such as “low tar” or “light,” are truthful and demonstrated by sound science.

So today we issued a draft guidance that provides direction for tobacco companies when they submit applications for modified risk tobacco products – MRTPs – tobacco products that are sold, distributed, or marketed to the public for use to reduce harm or the risk of tobacco-related disease.

We want to make sure consumers and the public have an accurate understanding of the health risks of tobacco products—so mistaken beliefs don’t cause them to start or continue using products that lead to preventable disease and death.

We are doing everything that we can to protect all Americans – especially our youth – from the dangers of tobacco, and we’re hopeful these two additional steps will accelerate our goal to make tobacco-related disease and death part of America’s past – not its future.

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

Making it Real out in the Regions

By:  Alan Bennett

Making it real. It’s a dilemma we all face at the FDA when trying to explain many of our regulatory decisions. I face it every year when I give the “Regulation of Drugs and Medical Devices” lecture to upper level engineering students at Oregon State University.

These are the innovators and builders of the future. Many may develop or work on FDA regulated products during their careers. For most, I am the first, and may be the only, person who works at the FDA that they will ever meet. In the short time I have with them I feel the pressure of making them see the real world consequences to the public health of FDA’s regulatory actions.

Frankly I’ve always felt at some level that I have fallen short, but not this year. FDA’s involvement led to the recall of a product sold by a local firm in Oregon. A deep kneading shiatsu massage device, the “Shoulderflex,” lead to the strangulation of a young woman. The instructions tell purchasers to lie down and rest their neck and shoulders over the device’s moving “kneading fingers” which provide a shiatsu massage.  For the woman in Florida, her leather necklace became tangled in the moving “fingers.” The necklace became tighter and tighter and she was strangled.

I obtained one of the devices and took it to the class to provide something tangible to illustrate the importance of engineering safety into medical products. It worked. The product is labeled “helps relieve muscle pain” which led to a discussion of the intended use of the product and why intended use is important to FDA’s jurisdiction over the product and how it is regulated.

The students took a close look at the product. They wanted to determine just how the “fingers” had grabbed the necklace. Almost immediately they began to talk about how safety could have been engineered into the device. They came up with several engineering solutions that they felt the company had missed. In the end they concluded that the woman’s death could have and should have been avoided.

These kinds of very personal stories are really not that difficult to find. As a Public Affairs Specialist in Portland, Oregon, I spend most of my time trying to make clear to diverse audiences exactly how FDA protects the public health. I share those stories and try to add one fact that I recently learned from Commissioner Hamburg: while the FDA regulates products that account for almost 25 cents of every dollar spent by consumers, taxpayers only contribute on average about 8 dollars a year to fund the Agency’s operations.

No matter what our resource level, I will keep talking to those students and future innovators at Oregon State and the public about the critical difference FDA makes to their health and well-being.

Alan Bennett is the Public Affairs Specialist in FDA’s Office of Regulatory Affairs, Portland, Oregon Office.

FDA Voice Interviews Lawrence R. Deyton, M.S.P.H., M.D.

FDA Voice: What is your current position at FDA and, briefly, what is the mission of the Center for Tobacco Products?

Dr. Deyton: I joined FDA in the fall of 2009 as Director of FDA’s Center for Tobacco Products. CTP has a clear-cut mission: to help make tobacco-related death and disease part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every person and every family.  That means putting programs and regulations in place that will help people, especially children, to not start using tobacco products, help current users to quit, and educate Americans about the risks of tobacco use. 

Lawrence R. Deyton, M.S.P.H., M.D. FDA Voice: Can you tell us in basic terms about the Family Smoking Prevention and Tobacco Control Act?

Dr. Deyton: Sure. When the Tobacco Control Act was enacted in 2009, FDA was given a series of important new responsibilities and authorities to protect the public from the dangers of tobacco use. And we’re implementing and enforcing the law’s provisions as they take effect.

For example, we’re helping to reduce access and the attractiveness of tobacco to kids by restricting advertising, marketing and retail practices related to cigarettes and smokeless tobacco products. We’ll be educating Americans about the contents of tobacco products and smoke and, as we do, we’ll be helping families understand the health effects of tobacco use.

The law is also requiring tobacco manufacturers to register with us and submit information about their products and product ingredients, including additives. As incredible as it sounds, consumers of cigarettes, a mass-consumed product, currently don’t know the chemicals they’re inhaling that cause or have the potential to cause harm to them.  And, FDA now has the authority to set standards that can make tobacco products less addictive and harmful.

I should add that FDA has clear authority to enforce all these provisions. Take the case of retailers. Most retailers are happy to take on their new responsibilities under the Tobacco Control Act to make sure kids don’t buy cigarettes or smokeless tobacco products. But some are not.  And FDA has not been shy about using our authority to enforce penalties against them.

FDA Voice: Can you tell us how CTP is unique and how it differs from other Centers at FDA?

At CTP we’re regulating a product which, if you look at what is available today, is fundamentally unsafe. So, we employ a different regulatory standard than other centers: a public health/population health standard that focuses on reducing the health threat tobacco use poses to all of us, not just the individual consumer. That’s a different strategy than other FDA Centers use, but CTP is regulating a very different product.

FDA Voice:  If you could tell the American public one thing that they might not know about what CTP does to directly benefit them, what would it be?

Dr. Deyton: I think Americans ought to know that, even though we’re a new part of FDA, CTP is really grounded in values that have guided FDA since its inception: the belief that government has a responsibility to take action when people’s lives are needlessly put in danger.

You know, I’ve yet to meet anyone anywhere in this country who wants kids to start to use tobacco. Current smokers tell us, “Help keep this stuff out of kids’ hands.” They want them to grow up healthy. And I should add that those smokers also tell us how badly they’d like to quit. That’s why this law doesn’t only help to prevent initiation; it also promotes cessation and includes provisions for reducing the addictiveness and toxicity of future tobacco products. If we achieve these goals, we will accomplish our mission of making the harm caused by tobacco use part of America’s past, not America’s future.

Lawrence R. Deyton, M.S.P.H., M.D., is the Director of FDA’s Center for Tobacco Products

Diagnosing TB, One Test at a Time

By Alberto Gutierrez, Ph.D.

For centuries tuberculosis, or simply TB as it is commonly referred to today, was fatal for millions of people living around the world. Most people infected with the bacterium Mycobacterium tuberculosis, the most common cause of tuberculosis, show no symptoms of TB. However, approximately 10 percent of those infected, such as those with weakened immune systems, will develop active TB disease. With active disease, the bacteria generally attack a person’s lungs, but can also attack other parts of the body such as the kidney, spine, and brain. Tuberculosis is spread through the air when a person with active TB disease of the lungs or throat coughs, sneezes, or speaks. People who are close by may breathe in the bacteria and become infected.

The most common symptoms associated with active TB disease include: a persistent cough lasting for three weeks or longer, chest pain, weakness or fatigue, weight loss, night sweats, and fever. People infected with TB who also have weakened immune systems have a much higher risk for not containing the bacteria and developing active disease, which can be fatal if left untreated. Today, the disease is also a leading killer of people with HIV worldwide. 

Alberto Gutierrez, Ph.D.

Past and present experiences have taught us that the proper diagnosis of TB is critically important in order to prevent the spread of TB.

For our part, the agency recently announced plans to lower the risk classification for nucleic acid-based TB tests used to detect the presence of copies of tuberculosis bacterium genetic materials (RNA or DNA) in a mucus (sputum) sample obtained from the person. This type of test allows for the timely identification of TB disease.

These tests can diagnose active TB infections in one to two hours and when used in conjunction with other clinical tests, can result in earlier treatment, improved patient outcomes, and interrupt further spread of TB.

The FDA currently considers nucleic acid-based TB tests high-risk (Class III) medical devices that require the agency to conduct a rigorous review to verify the product’s safety and effectiveness before they are used with patients. Under the new proposal, these tests would be considered moderate-risk (Class II) devices.

While the pathway to market would be considerably shorter, given the importance of these tests, the agency has still provided guidance to the developers of these tests that identifies the risks associated with false positive and false negative test results, the risks to health care workers handling specimens, and makes recommendations on how to mitigate these risks.  

It is the FDA’s hope that this more streamlined and flexible regulatory approach will ultimately encourage the development of new and more innovative TB diagnostics that will aid us in our fight to prevent the spread and hopefully one day, eliminate the presence of TB.

Alberto Gutierrez, Ph.D., is the Director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health

Report Adverse Events and Sign Up to Get Medical Product Information with MedWatch

By: Jay Wattenberg

Have you ever wondered how FDA hears about side effects of drugs and other medical products once they are on the market? Or how product problems are discovered? FDA gets important reports of problems from the nation’s doctors, nurses, pharmacists, and their patients, through the MedWatch program.

MedWatch logoMedWatch, the FDA Safety Information and Adverse Event Reporting Program, has two parts. The first is a process that seeks and accepts the voluntary reporting of serious adverse events and product quality problems into the FDA. The second part is FDA’s timely release of clinically important, product-specific safety information. MedWatch gives healthcare providers and patients access to relevant safety information to share in their decision-making about therapeutic and diagnostic choices.

MedWatch Reporting:

MedWatch is a voluntary system, active after the product is introduced into healthcare system, and adverse event reports supplement what is known about the product beyond what was evaluated during clinical trials.

In 2011, FDA received 34,000 adverse event reports directly from doctors, other clinicians, and their patients. In addition, hundreds of thousands of reports are sent to manufacturers from these same groups of reporters and are received indirectly by the FDA each year.

Even just a few adverse event reports can be the source of a signal that may result in new information on how the product should be used or how a patient receiving the drug should be monitored. For example, a drug used to treat a serious illness was reported through MedWatch to have an effect on a patient’s heart function. This effect became evident after the patient had been receiving the drug for over two years. This patient’s case resulted in new recommendations on the doses of the product to be given to patients, and on monitoring patients taking it.

MedWatch Information:

The MedWatch web page, with over one million visitors each month, is your gateway into the FDA network of information for all human medical products, including drugs, biologic products, medical devices, or dietary supplements. It is a useful reference resource for the busy clinician, providing both individual product safety alerts, and a monthly compilation of safety labeling changes for drugs and relevant biologic products in a table format, allowing for quick review.

Sign Up Today!

MedWatch offers several ways to help you stay informed about the medical products you prescribe, use, or dispense every day, by sending safety alerts directly to you, as soon as they appear on the web site.

You can sign up here for free MedWatch safety alerts and you can follow MedWatch on Twitter. And, you can also receive safety alerts by text messaging directly to your cell phone – just look for the “Wireless Alerts” option in the MedWatch E-list signup!

Jay Wattenberg is a Technical Information Specialist in FDA’s Office of Special Health Issues

Protecting Against Radiation Contamination – The Japanese Nuclear Reactor Explosion a Year Later

By: Kelly Garnick

March 11th of last year began as a typical winter day in New England and a routine day at the Winchester Engineering and Analytical Center (WEAC), the FDA laboratory that tests for radiation contamination of food and medical products, and where I have worked as a radio-chemist for 22 years. The reverie of that Friday abruptly changed when we learned that a powerful 8.9 magnitude earthquake and the resulting tsunami had devastated Japan’s eastern coast and that “something possibly was happening” at the Fukushima Daiichi nuclear reactors located in the area. 

Our small laboratory has responded to radiation-related public health concerns for more than 50 years and has a legacy that includes responding to nuclear weapons testing and the Three Mile Island and Chernobyl disasters. WEAC analyzes food samples for potential radioactive contamination daily and has planned, prepared, trained, and drilled for all types of emergencies.  And now we were faced with an actual disaster scenario – were we really ready?

Winchester Engineering and Analytical Center (WEAC) Building frontageEven before receiving any official assignments, we knew our WEAC team would be central to protecting U.S. consumers from any contaminated food and other FDA regulated products. We were excited, yet determined about this new situation – and knew it was unlikely we would be able to turn our Blackberries off for the foreseeable future. 

Because of the extensive devastation and infrastructure damage caused by the earthquake and tsunami, shipping came to a standstill in Japan. We prepared ourselves for an onslaught of samples but didn’t get any until late in the month. The first that arrived were fresh fish imports collected in Los Angeles. To ensure these perishable imported products were not contaminated, we committed to a two-hour turn around time for testing the samples and getting them back into commerce. The samples arrived first thing in the morning, which meant activity at WEAC began at midnight. We had to finish our calibration checks, background counts, and other preparations to be ready to act quickly as soon as the samples arrived.

Kelly Garnick filleting fishOne day is seared into my memory — April 19th. Four separate shipments with 69 samples from Japan arrived at WEAC’s door. One analyst arrived early to prepare instruments as two or three other analysts “claimed” their fresh fish samples and immediately began filleting and analyzing their catch. Before noon a second shipment arrived with 30 more samples. It seemed like the shipments were coming non-stop. Our staff of engineers and radio-chemists was cross-trained, but the volume was stretching our capacity. And just as our work day was ending, just when we thought we might be able to catch our breath, another shipment of more than twenty samples arrived!

Like all FDA employees during an emergency, we readily put aside family outings, soccer games, and the like, to protect the public health. In the past year, WEAC has tested more than 1,200 samples of drugs, devices, and various foods, including fresh fish, spices, curry, sake, and pet food imported from the affected area in Japan.  We also did testing for the Department of Defense to ensure that rations for our troops were safe. Bottom line, there were no reported incidents of American consumers coming in contact with foods or medical products contaminated by the radiation from the nuclear explosions. Because of our work, WEAC is now the prime lab used by DoD when it needs to ensure that the rations our troops eat are safe from radiation contamination.

A year ago, because of our training and simulation drills, we hoped we’d be ready to handle a real-world disaster when it came. Now, one year after experiencing an actual disaster in Japan, we know we’re ready.

Kelly Garnick is a Radio-Chemist in FDA’s Office of Regulatory Affairs, Winchester (MA) Engineering and Analytical Center

National Consumer Protection Week and FDA’s Fight Against Health Fraud Scam

By: Margaret Hamburg, M.D.

This week, FDA joins 29 other government agencies and a host of private groups to highlight National Consumer Protection Week, an annual event for consumers to learn how to protect their privacy, manage money and debt, avoid identity theft, and prevent frauds and scams. And, helping protect consumers against health fraud or scams is where the FDA plays a role.

For the FDA, banishing fraudulent remedies has been a top focus since the agency was created—and that was back in the early 1900’s, when consumer protection involved protecting consumers from peddlers of snake oil and “miracle” elixirs.

Margaret Hamburg, M.D.We’re still combating this illegal trade, but it has taken on a modern and much more prolific form. Health fraud scams are now advertised in newspapers, TV and cyberspace, promising sure-fire cure-alls, quick fixes, and “revolutionary remedies” for conditions that range from obesity to cancer. On FDA’s website, we define health fraud scams as the “deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial but scientifically unproven effect on health but that has not been scientifically proven safe and effective for such purposes.”  In other words, something that doesn’t do what it says it’s supposed to do.

Whether bought in a store or ordered by mail or online, products that fit this description—including drugs, dietary supplements, medical devices, biologics and cosmetics, many of which are produced and shipped from abroad—harm the buyers in more ways than one. These products can hurt consumers by delaying the proper diagnosis and treatment, causing serious or fatal injuries, and definitely wasting money.

Unfortunately, the deceit that makes this trade possible takes many forms. Some products—like the recently discovered counterfeit “Avastin”, which contained none of the approved and effective cancer drug—are worthless look-alikes of genuine medicines. Others are billed as “all natural” dietary supplements while containing hidden drugs and other chemicals that can be dangerous to health. Still other bogus products are promoted by statements that are misleading, false or not supported by scientific evidence.

The most common fraudulent products claim to prevent or treat such chronic diseases as cancer, arthritis, diabetes, heart disease, Alzheimer’s disease and multiple sclerosis. But other bogus cure-alls can emerge quickly in the wake of new public health hazards. For example, following the nuclear incident in Japan a year ago, the market was flooded with unapproved drugs claiming to provide protection from harmful radiation.

To keep these latter-day versions of snake oil from harming American consumers, FDA uses every tool in its legal arsenal. Since the start of 2011, our agency has warned more than 90 companies that inadequate or false labeling of ingredients and false or misleading claims of effectiveness violate FDA laws and regulations.

If there is no prompt corrective action, FDA takes additional enforcement measures. Since January 2011, 23 healthcare products—mostly supplements containing unapproved drugs — have been recalled from the market. In addition, at FDA’s request, U.S. marshals seized large quantities of fraudulent medications and dietary supplements. And side-by-side with steps taken in the United States, FDA works closely with authorities abroad to combat drug counterfeiters and to stop the sale of bogus products by foreign-based vendors on the Internet.

Despite these efforts, today’s media and globalized trade provide countless opportunities for purveyors of health fraud scams to victimize consumers. The most effective protection against this corruption is a healthy dose of skepticism. Every consumer can help combat health fraud by following three simple rules:

  • Be smart! If the offer sounds too good to be true, it’s probably a scam.
  • Be aware! Claims such as “Miracle Cure” or “Quick Fix” are red flags—learn to recognize them.
  • Be careful! Before taking an unproven or little known treatment, talk to a doctor or health care professional—especially when taking prescription drugs. And be especially cautious when buying medical products online.

To learn more, I encourage consumers to visit the National Consumer Protection Week website for the location of the events of the National Consumer Protection Week. Some of the programs—for example, in Philadelphia, Pennsylvania, in Tallahasee, Florida, and in Cincinnati, Columbus and Kettering in Ohio—include presentations by FDA staff.

And remember that at all times, there is a wealth of information on how to prevent and report health fraud scams on our website.This web-site contains videos and articles on how to avoid fraudulent schemes, and offers information about products that have been seized, recalled or are the subject of warnings from the agency.

Americans can count on FDA to continue doing its utmost to protect consumers from health fraud. But, the National Consumer Protection Week is a reminder that exposing and avoiding fraudulent products is a public health mission in which every one can, and should, do their part.

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

Keeping the Focus on Scientific Integrity

By: Jesse L. Goodman, M.D., M.P.H.

Science, both its quality and its integrity, is key to everything we do at FDA. As a physician and researcher, science has always been central to the decisions I make at the bench or at the bedside.  And now as the Chief Scientist for FDA, my office works across the agency to support our scientists and their cross-cutting scientific and public health efforts – and to help ensure that our decisions are science-based and protect and promote the health of the American people.

On a daily basis, I’m impressed with the professionalism of my colleagues and the thoughtful scientific discussions that help inform the important decisions we make.  While there may be differing views of what we can or cannot conclude from the science and data on which we rely, and while there are often multiple options that can be considered in developing a policy approach or making regulatory decision, FDA’s scientific decision-making on difficult issues must always be the product of an open and honest debate by the agency’s well-qualified employees. It is for these reasons that we stood up two new offices within the Office of the Chief Scientist whose missions explicitly include supporting Scientific Integrity (OSI) and Scientific and Professional Development (OSPD).

As reflected in the results of a survey of FDA scientists published by the Union of Concerned Scientists (UCS) today, with all of your help, FDA continues to make major strides in the area of scientific integrity.  The overall response rate of FDA employees to the survey was low and makes definitive conclusions difficult.  But, when compared to the results of a similar survey in 2006, which had a similar response rate, respondents have developed more confidence in the agency’s approach to science and the integrity of FDA leadership.  For example:

  • Scientists have more respect for overall agency leadership and their supervisors.
  • Supervisors show more support for scientists pursuing potentially contentious research.
  • Scientists feel better supported in pursuing professional development.

Even though, as noted, the opinions of those responding to the survey are generally more positive than in 2006, and even though the percent of respondents is low and may not accurately represent all employees’ views, there are some findings that should still concern us.   For instance:

  • Some scientists still fear retribution for sharing concerns about the FDA.
  • Some believe that business interests frequently influence science-based regulatory decisions.

Preserving and protecting scientific integrity and working to promote an environment where all feel comfortable expressing their opinions and have confidence in the Agency’s decision-making, must be an ongoing effort and part of our daily life and culture.

To that end, we recently put in place an agency-wide policy that sets forth key principles of scientific integrity and highlights important procedures and policies we have put in place at FDA that further those principles.  OSI, and myself as Chief Scientist, are committed to continuing to work with all of FDA to promote scientific integrity.  As set forth in the staff manual guide (SMG) on scientific integrity, FDA supports the following key principles:

Key Principles of Scientific Integrity at FDA

  • Maintaining a firm commitment to science-based, data-driven decision-making;
  • Shielding the agency’s science and its scientific staff from political influence;
  • Facilitating the free flow of scientific and technical information;
  • Protecting the integrity of scientific data and ensuring its accurate presentation, including the underlying assumptions and uncertainties;
  • Requiring a fair and transparent approach to resolving internal scientific disputes, including hearing and carefully considering differing views;
  • Supporting whistleblower protections;
  • Selecting and promoting scientists based on their knowledge, expertise and integrity;
  • Utilizing peer review of data and research used in decision-making, where feasible, appropriate and consistent with the law;
  • Maintaining openness and selecting qualified advisory committee members based on expertise, with transparency about conflicts of interest;
  • Allowing FDA staff to communicate their personal scientific or policy views to the public, even when those views differ from official Agency opinions; and
  • Promoting the professional development of our scientists by encouraging publication in and editorial service to peer reviewed journals, presentations at professional meetings, and full participation in appropriate professional or scholarly societies and related activities that may benefit the public health.

Dr. Hamburg and I are strongly committed to these principles and will continue to support FDA’s staff in its pursuit of scientific excellence and integrity in providing, reviewing, and disseminating data used to make decisions that affect the health and safety of people every single day. While everyone may not always agree on a complex decision or policy, and while we often must act in the face of real uncertainties, we must do so with the highest integrity. And though this survey helps confirm that we are making progress, protecting scientific integrity will require continuing commitment and attention. I welcome your ideas and suggestions.

Jesse L. Goodman, M.D., M.P.H., is FDA’s Chief Scientist and Deputy Commissioner for Science and Public Health

FDA’s Strategy of Creating Alliances

By:  Joy Johanson, MPH

Webster’s defines “alliance” as “an association to further the common interests of the members.” When it comes to food safety, the common interest is pretty clear–reducing the burden of foodborne illness in the United States where currently one in six Americans is likely to suffer a foodborne illness each year, according to the Centers for Disease Control and Prevention.

To reach that goal, FDA has embraced a strategy of working with alliances for various foods aimed at education, training, and technical assistance for industry and government food safety officials.

Four bowls of sproutsThe latest is the Sprouts Safety Alliance, of which I’m a coordinator along with Stephen Grove of the Illinois Institute of Technology’s Institute for Food Safety and Health.

FDA’s first effort at taking part in an alliance was in 1994 when the agency mandated a hazard analysis and critical control point (HACCP) regulation for seafood.  Knowing that this was a sea change (pardon the pun) for the industry, FDA worked together with representatives of industry, the academic and research community, and government officials from all levels to create the Seafood HACCP Alliance.  By leveraging the knowledge and expertise of the various parties, the Seafood HACCP Alliance has over the years provided critical training and educational materials to industry and regulatory officials to meet the evolving challenges of seafood safety.

This model of knowledge creation and dissemination proved so successful that the Juice HACCP Alliance was created in 2001, when FDA put in place HACCP standards for the juice industry.

Now, in anticipation of the issuance of rules mandated by the FDA Food Safety Modernization Act, three more alliances have been created in the last two years: the Produce Safety Alliance in 2010, the Preventive Controls Alliance in 2011, and now the Sprouts Safety Alliance.

In each case, the alliances are developing a core curriculum and training and outreach programs for stakeholders.  For instance, the Produce Safety Alliance held a meeting in Florida last year where stakeholders across the country had the opportunity to share existing educational materials and discuss what new materials were needed.  Since that meeting the Produce Safety Alliance has had working committees with members from 34 states focused on the job of developing the elements of a core curriculum.

The need for a sprouts alliance is obvious.  According to FDA data, between 1996 and 2010, 34 outbreaks of foodborne illnesses have been associated with sprouts in theUnited States.  These outbreaks have resulted in 2,150 cases of illness, 123 hospitalizations, and one death, and these numbers likely are an underestimate of the true public health burden from these outbreaks. 

Sprouts present a unique safety risk because the warm, moist, and nutrient-rich conditions required to produce sprouts are the very same conditions that are ideal for the growth of pathogens such as Salmonella spp. and E. coli O157.  So it is important that we enhance our efforts to identify and promote implementation of best practices in the safest possible production of sprouts. 

In developing its core curriculum and training and outreach programs, the Sprouts Safety Alliance will build on the significant work already performed in this area by a number of groups.  Such activities include the Sprout Safety Taskforce, formed between the Illinois Institute of Technology and a number of sprout companies, which has developed a Sprout Safety Audit Checklist for growers to use in reviewing their own operations and for use in sprout-specific third party audits.

The Sprouts Safety Alliance will have members from FDA, local and state food protection agencies, the food industry and the research/academic community. Like the other alliances, the Sprouts Safety Alliance is anchored at an institution with an established track record in food safety education and outreach.  FDA has provided a one-year $100,000 grant to the Illinois Institute of Technology’s Institute for Food Safety and Health. The Institute is also the headquarters for the Preventive Controls Alliance. 

We are eager to begin the hard work of our alliance with our partners because the common interest is so important: protecting consumers by ensuring that the sprouts industry has access to the best science-based knowledge on minimizing risk in the growing, harvesting, and handling of sprouts.                                                         

Joy Johanson, MPH, is Consumer Safety Officer for Produce Safety at FDA’s Center for Food Safety and Applied Nutrition.

Advocating for Patients with Rare Diseases

By: Debra Y. Lewis, OD MBA

This week we commemorate the fifth annual Rare Disease Day, a global campaign to raise awareness of the millions of people worldwide who suffer from rare diseases. In the United States, about 30 million Americans have rare diseases, so in reality, rare diseases are not so rare when viewed together as a group.  Because of the recognition of the need for therapies for rare diseases, today FDA held our first-ever Rare Disease Patient Advocacy Day.  

Rare Disease Patient Advocacy Day at FDA March 1, 2012 Stick figures of familes with the in front of the earthFDA designed Patient Advocacy Day to help patients and caregivers engage with us on issues related to drug and medical device development for rare diseases and conditions. Today gives rare disease patient advocates the opportunity to meet with FDA staff and learn more about how FDA works. And, as we come together with colleagues, families, patients and advocacy groups, it gives FDA a moment to reflect on recent news in helping people with rare diseases. 

We often talk about how important the Orphan Drug Act has been in bringing treatments to people with rare diseases – notably children with rare diseases. And we can see its impact. A new study published this week in Pediatrics highlights the progress we’ve made over the past 10 years in bringing treatments to children with rare diseases. The study reports that from 2000 to 2009, 1138 “orphan” drugs were designated and 148 received FDA approval, of which 38 were for pediatric diseases. The proportion of approvals for pediatric products increased from 17.5% in the first half of the decade, to 30.8% in the second. Orphan Drug Act incentives have led to increased product availability for rare diseases overall, with an increasing number of marketing approvals for children in the past decade.

And in 2011, FDA approved 26 drugs and biological products for rare diseases.  About one-third of all new molecular entities approved by the agency were for rare diseases. FDA also approved six medical devices for rare conditions under the Humanitarian Device Exemption program in 2011. We are very proud of the collaborations between industry, patient advocates and FDA that have made this a reality.  

There are over 400 drugs and devices approved for rare diseases and conditions, and millions of lives have been saved or improved with these new products. However, we still have much to do to meet the rare diseases challenge – there are 7000 rare diseases and most are without a current treatment available. Meeting this challenge is the focus of FDA’s Patient Advocacy Day today and will continue to be in the coming years as we strive to improve the lives of all Americans impacted by a rare disease.

Debra Y. Lewis, OD MBA, is Deputy Director of FDA’s Office of Orphan Products Development