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

Driving Innovation Is a Key Part of Our Mission

By: Margaret A. Hamburg, M.D. 

Ensuring the safety of the food supply and the safety and effectiveness of drugs, devices and biologics has always been at the core of FDA’s responsibility to protect the public health – and always will be.

Margaret Hamburg, M.D.But what is often lost or neglected in discussions about FDA’s vigilance on behalf of consumer and patient safety is how this kind of oversight and regulation, when done right, can be a key driver of innovation throughout society. Whether it involves the development of some remarkable new drug or oversight of a particular product, the addition of rigorous regulatory science from FDA helps to safeguard the safety and effectiveness of innovative new products; ensures that these scientific achievements quickly reach their full potential; and builds a pathway for ongoing innovation. That’s why we continue to adapt and change regulatory policies in response to – and in anticipation of – scientific opportunities so that they can best be harnessed to improve health and medical care.

There are many recent examples of this thoughtful approach to innovative products. For instance, we have put in place a new breakthrough pathway to market for promising drugs that may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Using this new approach, we have already approved two treatments for rare types of cancer and one for hepatitis C. And there may be considerably more in the weeks and months ahead because many companies have expressed interest. So far we have received 119 requests for designation and granted 35. 

In a very different realm, another example is mobile medical apps. We took a measured and sensible approach that promotes innovation when we finalized guidance related to these devices earlier this year. Although many mobile apps pertain to health, CDRH intends to focus its oversight on a very small subset of those mobile apps that are medical devices. We have called that subset “mobile medical apps” and we are approaching their regulatory oversight within a risk-based framework. We believe this approach will promote innovation while protecting patient safety by focusing on those mobile apps that pose greater risk to patients. 

As explained in the final mobile medical application guidance, our regulation of software as a medical device – and a mobile app is software – is based on risk and functionality, and that functionality should be treated the same regardless of the platform on which it is used. For example, an electrocardiography device – an ECG machine – that measures heart rhythms to help doctors diagnose patients is still an ECG machine regardless of whether it is the size of a bread box or the size of a smartphone. The risks it poses to patients and the importance of assuring for practitioners and patients that it is safe and effective are essentially the same. 

And, just a few weeks ago, we authorized for marketing four innovative gene-sequencing devices. Two of these products comprise a system that allows laboratories to develop clinical tests that can look at a person’s genetic makeup and detect abnormalities that could be responsible for illness. FDA realized the innumerable uses of these systems from the outset, and rather than focusing on specific diseases or areas of the genome, we took a tool-based regulatory approach. We assessed whether the devices overall measure what they are intended to measure accurately, reliably and precisely so that there can be greater confidence in the test results. These types of genome sequencers represent a significant step forward in the ability to generate genomic information that may ultimately improve patient care.  

Each of the new medical products we approve and usher to the market involves a balancing of risks and benefits, which is based on study and evaluation of hard data and the best available science. It is a huge responsibility that FDA is charged with, nowhere more so than when dealing with unfolding technologies that offer enormous potential – but that also may present real risks for people and their health.

We know there will be new and continuing challenges that arise with additional technological developments and advancements in science and medicine. This is why FDA’s regulatory role in these emerging areas continues to develop as well, sometimes even as the technologies themselves are taking shape 

But our goal remains constant – to protect the public health through smart regulation that helps to enhance innovation and ensure that new medical technologies have real value to the people who will use them, and that they are used effectively and safely to address their needs.

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

Personalized Medicine: The Future is Now

By Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.The difference between science and science fiction is a line that seems ever harder to distinguish, thanks in part to a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients.

Today cancer drugs are increasingly twinned with a diagnostic device that can determine whether a patient will respond to the drug based on their tumor’s genetic characteristics; medical imaging can be used to identify the best implantable device to treat a specific patient with clogged coronary arteries; and progress in regenerative medicine and stem cell therapy using a patient’s own cells could lead to the replacement or regeneration of their missing or damaged tissues. Given these trends, the future of medicine is rapidly approaching the promising level of care and cure once imagined by Hollywood in futuristic dramas like Star Trek.

But these examples are not science fiction. They are very real achievements that demonstrate the era of “personalized medicine” where advances in the science of drug development, the study of genes and their functions, the availability of increasingly powerful computers and other technologies, combined with our greater understanding of the complexity of disease, makes it possible to tailor treatments to the needs of an individual patient. We now know that patients with similar symptoms may have different diseases with different causes. Individual patients who may appear to have the same disease may respond differently (or not at all) to treatments of that disease.

FDA has been playing a critical role in the growth of this new era for a number of years. Even before I became FDA Commissioner the agency was creating the organizational infrastructure and putting in place the regulatory processes and policies needed to meet the challenges of regulating these complex products and coordinating their review and oversight. It has been my pleasure to serve at FDA during this next exciting period and to help ensure that the agency continues to prioritize this evolution by anticipating, responding to, and encouraging scientific advancements.

I am very pleased to be able to present a new report by FDA as part of our ongoing efforts in this field. Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development describes many of the exciting developments and looming advances in personalized medicine, lays out the historical progress in this field, and examines FDA’s regulatory role: from ensuring the availability of safe and effective diagnostic devices, to addressing the challenges of aligning a drug with a diagnostic device, to post-market surveillance.

Outside collaboration and information sharing is essential for this field to flourish. On Tuesday, the American Association for Cancer Research and AdvaMedDX held a fruitful daylong conversation on personalized medicine to treat cancer. I was one of the speakers, participating in a conversation with Dr. Francis Collins, the head of the National Institutes of Health. Our discussion focused in part on current status of drug and diagnostic co-development and the challenges and potential of whole genome sequencing, where data can be collected on a patient’s entire genetic makeup at a reasonable cost in a reasonable amount of time.

FDA is committed to fostering these cooperative efforts, as it will require the full force of government, private industry, academia and other concerned stakeholders to maximize our efforts and fully realize the promise of personalized medicine. Our new report outlines that commitment, and helps chart the way forward so that more people can live long and prosper.

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

Thinking Globally to Strengthen Science and Public Health Locally

By: Margaret A. Hamburg, M.D.

There are many good reasons to go to Arkansas in September. To visit Little Rock, nestled in the rolling hills between the Ouachita Mountains and the Arkansas River, and recently chosen as America’s number one most livable city. To attend the Annual Eureka Springs Antique Automobile Festival or the Ozark Quilt Festival. Or to take in the William Jefferson Clinton Presidential Library in Little Rock or visit his childhood home in Hope. And yet, none of these were the prime rationale for why more than 100 scientists, researchers, government regulators, and students from around the world came to this state. Instead, these committed individuals traveled from places as far away as Brazil, South Korea, and Australia to attend the Third Annual Global Summit on Regulatory Science hosted this week by FDA’s National Center for Toxicological Research (NCTR). 

Margaret Hamburg, M.D.They were here to help plan and build an organization to ensure that at a time of growing global demands and pressures, we can more efficiently turn the extraordinary potential and promise of science and technology into real-world products and programs that matter and make a difference to the public health.

The concept at the heart of this gathering is an occasionally neglected but fundamental component of the scientific enterprise and of FDA’s work and mission, regulatory science. Regulatory science is critical to speeding innovation, improving regulatory decision-making, and strengthening our ability to better assess the safety, quality and efficacy of a wide range of products, including food, drugs and devices. It is the work of regulatory science that truly enables us to have the knowledge and tools needed to translate scientific discovery and innovation into the products that hold such great promise.

That’s why one focus of the meeting was how to build a training model for regulatory scientists. Because even when individual nations have high standards for scientific training, fully leveraging the opportunities in science today requires an added focus on the specific critical thinking skills necessary to design, implement, and interpret studies within the regulatory context.

A number of programs at FDA for instance, are helping to ensure that scientists – both at the agency and around the globe – have this foundation. For example, NCTR has been collaborating with various Arkansas universities for a number of years to offer research training opportunities through a fellowship program that offers research training to postdoctoral students, as well as a training program for summer interns at the undergraduate level. So far, these programs have helped train students from more than 47 countries, as well as within Arkansas and across the nation.

One program I am especially excited by is the Arkansas Center of Excellence in Regulatory Science (ACERS), a public-private partnership that grew out of a Memorandum of Understanding I signed with the State of Arkansas in 2011. The five research universities that are part of the MOU are working collaboratively to join their vast computing capabilities, bioinformatics training, and other resources, with the equally impressive capabilities of NCTR and FDA to develop a powerful public resource. And just this week, at the Governor’s mansion, I signed the Partnership Intermediary Agreement, which will further strengthen the work of the Center, by facilitating the transfer of NCTR technology to the private sector.

Another important forward-looking aspect of ACERS is the creation of the Program in Regulatory Sciences at the University of Arkansas for Medical Sciences. This curriculum will help provide both current graduate students – and their broader scientific communities — with the critical skills needed to apply their scientific expertise to the decision-making needed for regulatory science within their specialties. These students represent the shape of things to come and provide an important step toward achieving the global promise of scientific innovation. 

All of this speaks to the second important principle at the center of this week’s gathering in Arkansas – strengthening opportunities for collaborations being built among scientists from different governments, academia, industry, and elsewhere. Quite simply, collaboration is a cornerstone of regulatory science.

FDA increasingly is required to act in an environment in which food and product safety and development know no global boundaries. To respond effectively we must strengthen collaboration among international partners. This will allow us to offer a unified focus on regulation in the name of science to help ensure the availability and safety of the supply of food, drugs, and other products around the world.

The discussions this week in Arkansas furthered the development of innovative technologies, approaches, and, perhaps most significantly, partnerships that enhance the use and translation of basic science into regulatory applications, as well as new collaborative systems for communication, education and training. These efforts offer extraordinary promise for the future of regulatory science in the global context and for the delivery of the kinds of innovative, safer and more effective products that patients and consumers expect and deserve.

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

FDA Goes 3-D

By Steven K. Pollack, Ph.D., and James Coburn, M.S.

Dr. Steven Pollack (left) holds a 3D-printed RoboHand, a prosthetic for children with amnionic banding syndrome, an illness that can prevent fingers from developing in children. Research engineer James Coburn (right) uses the 3-D printer (background) in his work in the FDA lab.

Dr. Steven Pollack (left) holds a 3D-printed RoboHand, a prosthetic for children with amnionic banding syndrome, an illness that can prevent fingers from developing in children. Research engineer James Coburn (right) uses the 3-D printer (background) in his work in the FDA lab.

This Snap-Together RoboHand Prosthetic, sized for a small child, was created at FDA with a 3-D printer.

The Snap-Together RoboHand prosthetic was invented by South African carpenter Richard van As and made available for free on the Internet. Before printing, the hand can be individually sized, and all connecting pieces are also printed. The device can now be printed for less than $100.

A hospital in Michigan implants a 3-D printed medical device into a 3-month-old boy with a rare bronchial condition and saves a young life.

A man has 75 percent of his skull replaced with a 3-D printed implant.

3-D printing—the process of making a three-dimensional solid object of virtually any shape from a digital model—is making headlines these days, and the technology, once considered the wave of the future, is rapidly becoming part of the present.

It’s spurring innovation in manufacturing, dramatically reducing the time required to design new products and allowing designs to be built that were not possible before.

Here at FDA, we’re using it to expand our research efforts and expand our capabilities to review innovative medical products. In fact, 3-D printing is fast becoming a focus in our practice of regulatory science—that is, the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.

With 3-D printing, the conversion from a virtual computer model to a physical object can occur almost in real time. The printer translates virtual models into digital cross-sections for use as a blueprint for printing, laying down successive layers in different shapes.

FDA Research Engineer James Coburn operates a RapMan kit 3D printer.

James Coburn adjusts the tension on the feed mechanism for the ABS plastic filament that is the raw material for the RapMan kit 3D printer.

Two laboratories in the FDA’s Office of Science and Engineering Laboratories (OSEL) are investigating how the technology may affect the manufacturing of medical devices in the future.

At our Functional Performance and Device Use Laboratory we’ve developed and adapted computer-modeling methods to help us determine the effect of design changes on the safety and performance of devices when used in different patient populations. The 3-D technology enables us to tweak the design in ways large and small, and to see precisely how those tweaks will change both fit and functionality. In an era of increasingly personalized medicine, which involves the development of treatments that are tailored to an individual patient or a group that shares certain characteristics, including anatomical features, it helps us to fine-tune our evaluation of patient-fitted products.

At our Laboratory for Solid Mechanics we’re investigating how different printing techniques and processes affect the strength and durability of the materials used in medical devices. What we’re discovering will be valuable to our reviews of devices down the road; it will help us to develop standards and set parameters for scale, materials, and other critical aspects that contribute to product safety and innovation.

In August 2012, President Obama launched the National Additive Manufacturing Innovation Institute (NAMII), a national effort bringing together industry, universities and the federal government to provide innovation infrastructure to support new technologies and products created with additive manufacturing, the formal term for 3-D printing.

FDA has a long history of researching and regulating innovative technological practices. Regulators regularly review some of the newest technologies coming onto the market and, through our research, FDA has first-hand knowledge of these advanced techniques so we can evaluate advanced technology at an early stage—a crucial step in facilitating innovation and protecting the public health. We will continue to facilitate device innovation and keep on the cutting edge of technology and regulatory science to help ensure that the products we regulate are safe and effective.

To see more photos of how FDA is using 3-D printing technology, visit our Flickr photostream.

Steven K. Pollack, Ph.D. is Director of FDA’s Office of Science and Engineering Laboratories (OSEL) at FDA’s Center for Devices and Radiological Health. James Coburn, M.S. is a Research Engineer in OSEL.

FDA Uses Web Tool to Better the Odds for Food Safety

By: Ted Elkin

When most people hear the words, “Monte Carlo,” they may think about high-stakes gambling.

We, however, think about reducing the risk in food safety through the use of FDA-iRISK, an innovative Web-based food safety modeling tool developed by the Food and Drug Administration and our partners.

Launched in October 2012, FDA-iRISK uses mathematical logic and Monte Carlo simulation (a computer program named for the gambling mecca) to integrate data and generate results that compare and rank risks of the contamination of foods by various hazards.  Unlike a traditional risk assessment of a single food and a single contaminant, FDA-iRISK allows users to compare multiple hazards – microbial or chemical – in multiple foods.

How does FDA-iRISK work?

Through extensive outreach to and collaboration with partners, we developed built-in templates and other features that allow the user to create real-world (or hypothetical) food safety scenarios.

The user provides the data for seven elements: the food(s), the hazard(s), the population of concern (for instance, elderly or immune-compromised), the production or processing system being used for the food, the consumption patterns, the dose response (what level of exposure will have a health impact), and how the health effects are to be calculated.

This allows the user flexibility, for instance, to look at the impact of potential interventions at various stages of the food production system as well as the populations affected.  And it’s easy to use.

Of particular benefit to the user is FDA-iRISK’s ability to generate reports that measure the health impact of an intervention in terms of the widely used public health metric, DALYs (“Disability-Adjusted Life Years,” meaning years of healthy life lost to illness or death).  This measure lets us know the “bang for the buck” of a particular intervention.

FDA-iRISK is quickly gaining acceptance and use in the food safety community.  As of the middle of May, almost 500 users had established accounts with FDA-iRISK and they came from every continent. Because it is web-based, FDA-iRISK is available to anyone in the world who sets up an account, and it is free to use.

Therefore, the knowledge and sharing power of FDA-iRISK is exponential.  As more users use it and generate reports that are then available to the other users, a more consistent, well documented, systematic, structured and quantitative picture of risk in the food supply will emerge, as well as scenarios for reducing risk.

“Information provided by iRisk can aid in developing global scientific exchanges aimed at maintaining and developing agricultural markets around the world,” according to Jamilah (Fagbene) Cassagnol, an international trade specialist at the U.S. Department of Agriculture.

FDA-iRisk is supported by an exceptional project team. FDA staff members Sherri Dennis, Yuhuan Chen, David Oryang, Regis Pouillot, Karin Hoelzer and Susan Cahill developed the tool in collaboration with Risk Sciences International, RTI International and the Institute of Food Technologists.

Ultimately, for food safety, Monte Carlo shouldn’t mean taking a gamble.  Rather, it’s all about using a quantified, standardized and transparent methodology to better understand what interventions and controls will reduce the risk and improve our public health.

Ted Elkin is Director, Office of Analytics and Outreach, at FDA’s Center for Food Safety and Applied Nutrition.

Basing Food Safety Standards on Science and Prevention

By: Margaret Hamburg, M.D.

Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply.

Margaret Hamburg, M.D.That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce.

The Preventive Controls for Human Food rule proposes that food companies—whether they manufacture, process, pack or store food— put in place controls to minimize and reduce the risk of contamination. The Produce Safety rule proposes that farms that grow, harvest, pack or hold fruits and vegetables follow standards aimed at preventing their contamination. 

These rules represent the very heart of the prevention-based reforms envisioned by the landmark FDA Food Safety Modernization Act (FSMA) and focus on preventing food safety problems before they happen.

These two rules are also part of a larger, ongoing reform effort, with other rules that set similarly high standards for imported and animal foods to be released in the near future.

In our interconnected world, FDA’s vigilance must extend globally. About 15 percent of our food is imported, and in some categories that percentage is much higher. For example, half of our fruits and a fifth of our vegetables come from abroad. We need a strategy that will address all of these complexities and challenges.

In drafting the proposed rules, FDA conducted extensive outreach and talked with key stakeholders, including farmers, consumer groups, state and local officials, and the research community. They build on existing voluntary industry guidelines and best practices for food safety, which many producers currently follow.

We want to continue to engage the public. So, I encourage Americans to review and comment on these rules, which are available for public comment for 120 days.

I believe this also showcases FDA’s adherence to solid science in its policy- and decision-making. The new draft rules recognize that the science of food safety is constantly evolving and that our oversight must take into account issues such as emerging disease-causing bacteria and new understandings of how hazards can be introduced into food processing.

FDA is committed to working with industry to provide the support they need, especially the smallest businesses. That’s why we are working with stakeholders through the Produce Safety Alliance, the Sprouts Safety Alliance, and the Preventive Controls Alliance to continue outreach efforts and to make educational and technical information readily available to industry.

Meeting the public health demands of a global marketplace. Bringing solid science to bear on our decision making. And safeguarding the well-being of American families with a prevention-focused food safety system. That’s FDA at work in the 21st century.

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

What is Regulatory Science?

What is regulatory science? And what does it mean to you and your family? Listen to top FDA officials and scientists explain the fields of research that make it possible for FDA to fulfill its mission of protecting public health. Regulatory science provides the evidence that FDA needs to know that products such as drugs, medical devices, vaccines, cosmetics and foods are safe for consumers. Regulatory science makes it possible for FDA to evaluate the safety and effectiveness of advancing technology, and to get innovative products to consumers as quickly as possible. It is difficult to count the number of ways in which this research affects the daily life of the average American consumer.

For more information about regulatory science, visit the Consumer Update series on this subject:

Why You Should Care About Regulatory Science

Personalized Medicine Will Fit You Like a Glove

FDA Targets Drug Side Effects

Emerging Technology Embraces the Future

Scientists Working to Keep Foods Safe

Regulatory Science Is Not Boring

By: Susan Kelly

I’m a relative newcomer to government work, joining FDA about 18 months ago after decades of being a journalist. My job is to assign, write and edit FDA Consumer Updates, news stories posted on fda.gov that are designed to give consumers important information in language that’s easy to understand. Not too technical or bureaucratic.

To endear myself to my new colleagues, I decided to write about anything that we saw as boring, leaving them to write about the hotter topics. I’m not easily bored, so I thought this would work as a noble gesture.

Even with this resolve, my heart sank when I was asked to write about regulatory science – one of FDA’s highest priorities. Do you remember the character Chandler Bing from the TV show “Friends”? I could hear his voice in my head: “Could this BE more boring?”

But I resolutely set about my task and five Consumer Updates later, I’m here to tell you that regulatory science is NOT boring. Not even close.

The official definition: “Regulatory science is the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.”

Ok. Put down the remote and give me a minute.

FDA has a huge impact on your daily life. Think about the foods you eat, medicines you take, vaccines your kids are given, the medical devices as commonplace as band-aids and toothbrushes and as complicated as an artificial heart, the foods and medicines you give your pets. FDA’s job is to make sure that products like these, and many, many more, do what they’re supposed to do —and do it safely.

Regulatory science is the proof that’s in the pudding, so to speak. It’s how FDA collects the scientific evidence it needs to determine if a regulated product will actually make your life better. It’s how FDA collects the scientific evidence it needs to ensure that the foods you eat at home or in restaurants are safe to eat. (How they taste is not our problem.)

Regulatory science identifies and tracks nasty bacteria that contaminate food. It creates genetic tests to determine if medication could work for you specifically—not just for people who are like you in some way. It puts human cells on a computer chip that mimic the function of organ systems, thereby possibly reducing the need to test new drugs on animals.

It’s the virtual family—a scary looking group of computer models that scientists can use to see what medical devices would work for their patients.

I especially liked meeting the scientists. Some of them struck me as a bit eccentric, as you might expect. Others are shy and reticent. What they have in common is a genuine commitment to make the world a better place – a safer place.

So the next time that you read the words “regulatory science,” take a second look. The work that goes on under that banner could save your life someday.

Susan Kelly is the managing editor of Consumer Health Information at FDA.