Produce Safety Rule: The Partnership Continues

By: Michael R. Taylor

The comment period for the proposed produce safety rule closed on Friday, Nov. 22, but this is far from the end of FDA’s collaboration on produce safety with growers, the food industry, and consumers. FDA will continue to engage stakeholders, and we are committed to engagement through a final rule’s ultimate implementation.

Michael R. TaylorThe proposed produce safety rule is an important part of the Food Safety Modernization Act (FSMA), along with new measures to prevent problems in food processing facilities and strengthen our assurances that imported foods meet U.S. safety standards. When finalized, the produce rule will set science-based standards for the safe production and harvesting of fruits and vegetables, whether grown here or in another country. It’s crucial for all concerned that the final rule be both right for food safety and as practical and feasible as possible for the many produce operations involved in supplying fresh fruits and vegetables to America’s consumers.

To help get the rules right, my team and I have traveled our country to get input from the people who will be most affected and have the greatest expertise. Just in recent months, we have traveled to the Pacific Northwest, New England, Michigan, and California. We’ve toured all kinds of farms, from small ones that have been in the family for generations and grow many different crops, to huge farms that grow one crop. We’ve visited food hubs, roadside stores and irrigation districts. We’ve been joined by staffers from the U.S. Department of Agriculture, extension agents, state agriculture commissioners and others. And there have been hundreds of listening sessions in which we’ve heard people speak frankly about their concerns about the proposed new requirements. What I want to say first to all the people we met and all those who have submitted comments is simply this:

Thank you.

The people I’ve met in all parts of the produce supply chain take great pride in the quality of their work and are committed to food safety. But they also feel that some parts of the produce rule as drafted won’t work, and they went to considerable effort – taking time out of their day, traveling to where we were, and waiting to speak to us – to help us understand their concerns. Particular concerns include the requirements that would affect irrigation water and the use of manure to fertilize crops. They also told us about parts of the rule with which they fully agree and want to be sure stay in place.

We now turn to the deliberations needed to craft a final rule, based on the thousands of written comments submitted to FDA and the input we received in our travels. While some concerns may be addressed through more precise language, others may need more changes, and a few may require substantial changes in what we’ve proposed. Rest assured that we will carefully consider these concerns and do whatever is possible to get these rules right. 

FDA will also engage stakeholders in the eventual implementation of the final rules. This includes continuing to work with the Produce Safety Alliance, state agriculture departments, and others in the produce community on education, training and technical assistance to support implementation by growers. They won’t be going it alone.

Keeping our food supply safe is FDA’s ultimate goal – and it’s a goal we know is shared widely by farmers, food distributors, and marketers throughout the food system. In field and factory, at the local food system level and over long supply chains, good people are working hard to keep your food safe. We look forward to an enduring partnership with this community as we work to finalize and implement the produce safety rule and the other important elements of the modern food safety system envisioned by FSMA.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Gene Sequencing Devices Are ‘Next Generation’

By: Jeffrey Shuren, M.D.

Just for a moment, imagine a scenario in which you have an illness that has eluded diagnosis. The usual suspects have been ruled out and no one knows exactly what’s making you sick. 

Using medical devices that FDA has now cleared for marketing, a laboratory could sequence your genome to look for any abnormalities in your genes that could be responsible for your illness. This information would be relayed to your doctor and used to determine the course of treatment.

This is called “next generation sequencing” because it’s another step towards a future in personalized medical care that few of us could have envisioned even a decade ago. 

First, let’s define some terms. A genome is the complete set of genetic information in your body. This information is held in sequences of DNA, and gene sequencing from your whole blood allows laboratories to look for genetic variations that could hold the key to the causes of disease and the right treatment. 

FDA is clearing the marketing of four gene-sequencing devices. Two of the devices make up the first test system authorized for marketing that allows laboratories to sequence a patient’s genome for any purpose. The software compares the patient’s sequence to a normal human genome sequence used for reference and identifies the differences. 

The other two devices are used to detect changes in the CFTR gene, which can result in cystic fibrosis, a disease inherited through a faulty CFTR gene from both parents. More than 10 million Americans are carriers of cystic fibrosis (they have only one faulty copy), and one of these tests could be used to identify men and women with the faulty CFTR gene. The second test looks for other, perhaps unexpected, mutations in the CFTR gene that could be having an impact on the patient’s health. 

Regulatory science – the science of developing new tools, standards and approaches to assess the safety, effectiveness, and quality of FDA-regulated products – played a key role in FDA’s readiness to assess these revolutionary devices. Knowing the potential of next generation sequencing to advance personalized medicine, FDA researched next generation sequencers to understand how they work and their likely limitations. By the time Illumina (the San Diego-based biotechnology company that developed the next generation sequencing devices authorized for marketing) walked in the door, FDA had the expertise and tools needed to timely review the submissions for the next generation sequencers. 

The regulatory science development efforts that contributed to the timely marketing authorization of these devices will continue to help advance this important technology. We are also collaborating with the National Institute of Standards and Technology – a federal agency that works to advance measurement science, standards and technology – and other agencies to develop human genome materials that can serve as reference materials so that other labs and researchers can assess the performance of their gene sequencers quickly, effectively, and at a lower cost.

We are working on many fronts to achieve the promise of personalized medicine, so that patients can get medical treatments that are right for them. Clearing the marketing of these four devices moves us closer to that goal.

For further perspective, read a new article in the New England Journal of Medicine by FDA Commissioner Margaret A. Hamburg, M.D. and National Institutes of Health Director Francis S. Collins, M.D., Ph.D.

Jeffrey Shuren, M.D., is Director of FDA’s Center for Devices and Radiological Health

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

FDA Uses New Authorities To Get OxyElite Pro Off the Market

By: Daniel Fabricant, Ph.D. 

As the head of the office that oversees dietary supplements, it is my responsibility to ensure that the dietary supplement products on the market — which are used by more than 180 million Americans daily — do not cause harm.

This is not an easy job because FDA’s authority to regulate dietary supplements is very different from the agency’s authority to regulate drugs and medical devices prior to their marketing. Adding to the challenge is the fact that there are more than 85,000 dietary supplement products and no requirement for product registration.

Just recently we had a case that illustrates both the limits of FDA’s authority to regulate supplements and the promise of new enforcement tools provided by the FDA Food Safety Modernization Act (FSMA). Dozens of people were suffering acute liver failure or non-viral hepatitis so severe that several needed liver transplants, and one died. These people, by and large, had been healthy.

The illnesses were linked to certain OxyElite Pro dietary supplement products made by Texas-based USPLabs. Certain OxyElite Pro products and a second product, VERSA-1, contain a new dietary ingredient that has not been shown to be safe for use by consumers. This ingredient, aegeline, is a synthetic version of an alkaloid that exists, in natural form, in a tree that grows in parts of Asia.

This is the second time in little more than a year that USPLabs has produced supplements containing a new dietary ingredient that lack a history of use or other evidence of safety. In the previous case, the company added a stimulant called DMAA (dimethylamylamine) to OxyElite Pro and to a similar product, Jack3D. We were alerted to the addition of DMAA through more than 100 reports of illness, including six deaths, among people who used the products.

Consumers may look at a capsule or tablet, the forms in which many supplements are sold, and not realize our limitations in regulating dietary supplements. In October 1994, the Dietary Supplement Health and Education Act expressly made supplement manufacturers responsible for ensuring that their products are safe. Under this law, manufacturers do not need FDA approval before selling dietary supplements. The burden is generally on FDA to prove that a supplement is unsafe before any actions can be taken to restrict its use or remove it from the market.

The law made an exception for “new dietary ingredients” (i.e., dietary ingredients not marketed in the United States before Oct. 15, 1994). Before supplements containing these new dietary ingredients – vitamins, minerals, herbs and other substances – can be sold, a manufacturer or distributor must provide FDA with information establishing their safety when used under the conditions recommended or suggested in the product labeling. USPLabs should have informed FDA of its plans to add aegeline to its dietary supplements, and it should have established the safety of aegeline in its products. Neither of those things happened.

We do not have the authority to evaluate and approve dietary supplements before they are sold to consumers. However, in this case we were able to invoke new enforcement authorities provided by FSMA to remove them from the market.

Key provisions under the new food safety law – mandatory recall and administrative detention – now play a critical role in allowing FDA to act quickly and decisively. We can now order a recall when there is a reasonable probability that an article of food is adulterated or misbranded under certain sections of the Federal Food, Drug, and Cosmetic Act and there is also a reasonable probability that the articles of food will cause serious adverse health consequences or death to people or animals. 

We also have the authority to administratively detain a food or dietary supplement to prevent its distribution if the agency has reason to believe the product is adulterated or misbranded.

We invoked our recall authority and warned USPlabs that FDA might order it to stop distributing the involved OxyElite Pro dietary supplements if the company did not stop distribution on its own and conduct a voluntary recall. USPLabs agreed to voluntarily recall the OxyElite Pro products and destroy all lots of the products, including remaining warehouse stock, which had an estimated value of $22 million. We will supervise the destruction of these products.

My colleagues and I will continue to use our new authorities, as appropriate, to make sure that the supplements you take will not put you in the hospital. We are committed to keeping you and your family safe, using every tool at our disposal.

Daniel Fabricant, Ph.D., is Director of FDA’s Division of Dietary Supplement Programs

We’re Partnering with Mexico to Keep Foods Safe

By: Michael R. Taylor 

En Español

Food safety is an issue that crosses borders. The reality of this global marketplace is that consumers, industry and governments worldwide are in this together. 

Deputy Commissioner Michael Taylor (on r) and Dr. Ricardo Cavazos, General Director of Economic and International Affairs at the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)

With that in mind, my team and I traveled to Mexico City on Oct. 29, 30 and 31 to discuss the rules that FDA has proposed this year to help ensure the safety of both domestic and imported foods. 

We said at the beginning of our efforts to implement the 2011 FDA Food Safety Modernization Act (FSMA) that we would send FDA delegations to Canada, Mexico, Europe and China to strengthen partnerships with officials there to help accomplish our safety goals. Working with our government partners in the U.S. and abroad is important in making sure that implementation is successful. This trip was the last of these journeys, and it was a great experience. 

Why is a partnership with Mexico important? Because it is one of the United States’ top trading partners. A lot of the produce we eat in the U.S. is grown there, including fruits and vegetables that would otherwise be hard to find in the winter months. 

What we learned in meetings with SENASICA and COFEPRIS – two key food safety agencies in the Mexican government – is that we’re all on the same page when it comes to food safety. We share with Enrique Sanchez Cruz, director general of SENASICA, Mikel Arriola, federal commissioner of COFEPRIS, and their able staffs a commitment to protect our citizens from the contaminated foods that cause so many preventable illnesses each year. 

And there is much we can do to help each other. For example, our counterparts in Mexico have a great deal of data to share based on microbiological sampling of foods and inspections. And, like us, they base their food-safety priorities on risk: What are the greatest potential hazards? We came away with a much deeper understanding of their work in this area. 

One of the key messages we got from our Mexican colleagues was that they are eager and committed to working with us to implement FSMA, and this motivates us to take our partnership to a new level. The benefits will be mutual, as FSMA and Mexico’s own food safety initiatives promise to elevate standards and improve practices on both sides of the border. 

At a public listening session on our FSMA proposals attended by representatives of major commodity groups, the sentiments were much the same. They want to be engaged with us in this important work. 

We envision partnerships with our foreign counterparts as being multi-faceted, including data sharing, recognition of inspection reports, multilateral sharing and acceptance of laboratory methods, and training of government and industry on U.S. food safety requirements, and where appropriate, cooperating under trade agreements. 

We know food safety is more a journey than a destination, and the road we are on with Mexico will have its bumps and seem long at times. But, thankfully, we are on the road together, and we will get there. 

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Ensuring Safe Food and Medical Products: A Partnership with the Mekong Region

By: Margaret A. Hamburg, M.D.

Several years ago I had the opportunity to visit the Mekong Region of Southeast Asia, which includes the countries of Cambodia, Laos, Myanmar, Thailand and Vietnam. I was struck not only by its beauty, dynamism, and diversity, but also by the commitment of health officials there to building strong health systems and cooperating across borders in the face of potential health threats. I learned that by working together with each other and the United States they were able to build an effective rapid response to outbreaks of an emerging pathogen such as the H5N1 influenza virus.

Margaret Hamburg, M.D.I was reminded of my visit this week during my participation at a forum hosted by the Center for Strategic and International Studies entitled “U.S. Health Partnerships in the Mekong Region.” The day’s discussions highlighted the growing strategic importance of the region to the United States and the long-standing and ongoing partnerships between U.S. agencies and regional partners in health and development, including the central focus of the FDA, to ensure the safety of food and medical products in the United States.

Though Americans may not often think about it, the U.S. is increasingly and inextricably linked to the Mekong Region through global supply chains. For instance, about 15% of the seafood we consume in the United States comes from Mekong region countries, arriving on our shores and in our stores after a long and circuitous journey. Consider tuna, which may be caught in the South Pacific, transported to New Zealand for pre-canning, and shipped to Southeast Asia for canning before it finally makes its way to the East Coast of the United States for distribution in this country. 

Why does this matter to FDA? There is a greater likelihood that food will be exposed to pathogens, contaminants or chemical hazards during a journey of this complexity. That’s why we work closely with our regional counterparts in these countries through such organizations as the Association of Southeast Asian Nations (ASEAN) and the Asia Pacific Economic Cooperation (APEC), sharing with them our own regulatory requirements, our knowledge of good manufacturing practices and our laboratory and inspection techniques. Through such information sharing we believe we can prevent tainted or otherwise unsafe foods from reaching our borders. 

But the risk of potentially unsafe food from this area is not our only concern. A significant threat to human safety today involves substandard, falsified and counterfeit medical products that are part of the global supply chain. These products may contain toxic ingredients, or too much or too little of a drug’s active ingredient, and as a result patients could be poisoned or unwittingly receive inadequate treatment for their disease or even no treatment at all. In addition, if too many patients receive only partial treatment, it might foster the development of drug-resistant disease strains. And there’s this too: a high prevalence of substandard and falsified medicines ultimately will erode public trust in the health care system.

Unfortunately, statistics suggest that substandard and falsified products is a problem in the Mekong Region. A recent comprehensive review found that in Southeast Asia, 35 percent of anti-malarial drugs were substandard and 36 percent were counterfeit. And many of the countries in this region have porous borders and face challenges with regulatory oversight and enforcement practices that cannot adequately protect the supply chain. 

FDA is working with the World Health Organization to build a global monitoring system to monitor substandard, falsified and counterfeit medicines, and collaborating with countries in the region to develop and test the system. In addition to cooperating with our regulatory counterparts across the globe on issues of detection, investigation and enforcement, FDA scientists have developed the Counterfeit Detection Device, or CD-3, which can quickly screen for counterfeit products – not just drugs – at any location, including remote communities and border sites. With our international partners, we are currently planning to expand the use of this tool in several field settings, including in the Mekong region.

Building cooperation for this kind of enforcement is essential not just to ensuring the safety of our food and medical products, but as a means of advancing our national security objectives. That’s why meetings like the one I attended this week are so important. They support opportunities to work with our colleagues in the Mekong region on ways to share information and promote stronger, innovative regulatory systems that are critical to the long-term success of our global public health efforts.

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

Working to improve the communication of important drug safety information about generic drugs

By: Janet Woodcock, M.D. 

FDA is taking a step today that is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients. 

All drug manufacturers are required to keep close tabs on their drugs once they go to market, reviewing all reports of adverse events involving their drug and reporting these findings to FDA. 

But currently, only brand name manufacturers are able to independently update and promptly distribute revised drug safety information, also called labeling, and they can distribute that information before FDA has reviewed or approved the change. These updates, which are submitted in changes being effected supplements, ensure that this important safety information gets to the public as quickly as possible. 

Right now generic companies, who are responsible for over 80% of the prescription drugs dispensed to patients, aren’t able to revise their drug safety information as quickly as the brand name. They must provide supporting information to FDA, which then determines whether safety information for both the brand and generic drugs should be revised before updates can occur. 

Today, FDA is issuing a proposed rule that would allow generic drug manufacturers to independently update and promptly distribute revised product labeling — just like brand name manufacturers – before FDA reviews or approves the change. 

Empowering generic drug companies to update their own drug safety information is intended to provide them the incentive to more actively participate with FDA in ensuring the timeliness, accuracy, and completeness of this information. 

The brand manufacturer would be expected to consider the information provided by the generic drug manufacturer as part of its review and evaluation of adverse drug experience information for its drug. 

And to make sure that the drug safety information updates from both generic and brand name companies are readily available to health care professionals and the public, FDA plans to post these updates on its website. 

Faster safety updates and easier access to this information should be a win–win for all involved. 

Janet Woodcock, M.D., is director of FDA’s Center for Drug Evaluation and Research

Trans Fat: Taking the Next Important Step

By: Michael R. Taylor 

With all of our worthy focus on implementing the Food Safety Modernization Act this past year, we must not lose sight of other critical areas in which FDA, and specifically the Center for Food Safety and Applied Nutrition, must work and be effective to protect public health. 

One of our core regulatory functions is ensuring that food, including all substances added to food, is safe.  If evidence suggests that a product already in use is unsafe, we take steps to protect the public health. That is what we are doing in the case of partially hydrogenated oils, the major source of artificial trans fat. 

There is a lot of evidence showing that trans fat intake can increase the risk of heart disease by raising low density lipoprotein (LDL) cholesterol, commonly referred to as “bad” cholesterol. Trans fat has been a concern for some time, and that is why ever since 2006, FDA has required that food manufacturers declare the amount of trans fat on the Nutrition Facts label. 

We’ve come a long way since then. In the United States, consumption of trans fat from products containing partially hydrogenated oils has declined dramatically from 4.6 grams per day in 2003 to about 1 gram per day in 2012, according to FDA estimates. And food manufacturers have made significant progress to reduce the levels of trans fat in processed foods. But there are still many processed foods with trans fat including some snack foods, microwave popcorn, frozen pizzas, cakes, cookies, stick margarine products, coffee creamers, pies, and ready-to-use icing products. Many restaurants are also cooking with less trans fat. Elimination of industrially produced trans fat from foods could prevent 20,000 heart attacks and 7000 heart-related deaths each year. 

So now we are ready to take the next important step that could lead to the removal of partially hydrogenated oils from processed foods. Partially hydrogenated oils have long been considered by industry to be “generally recognized as safe,” or GRAS, for their use in food. GRAS status implies that they are regarded by experts as safe under the conditions of intended use. This means they can be added to food without being approved in advance by FDA. 

Because of the evidence linking trans fats to an increase in the risk of heart disease, however, FDA has preliminarily determined that partially hydrogenated oils are no longer GRAS for any use in food. We are providing a 60-day comment period to ask for additional information. If, after reviewing the comments and scientific information submitted, FDA makes the final determination that partially hydrogenated oils are not GRAS and are not otherwise authorized for use in food, such oils become unapproved food additives. That would make their use unlawful unless a company or other petitioner could prove to FDA that one or more specific uses are safe under the “reasonable certainty of no harm” safety standard. 

If FDA ultimately determines that partially hydrogenated oils cannot be used in food, we recognize that it may take some time to phase out their use. Therefore, in our notice we are seeking input on the time that industry would need to remove partially hydrogenated oils from the food supply. If we finalize our tentative determination, we would provide industry with time to comply. 

Consumers who are interested in reducing their trans fat intake can take steps now. First, choose products that are labeled as having “0” trans fat. But under current regulations, even these products can have up to 0.5 grams of trans fat per serving, which can add up depending on what foods you choose. So in addition to choosing products labeled “0” trans fat, you can check the ingredients statement and avoid products that contain partially hydrogenated oils. 

Protecting the safety of the food supply can mean a lot of different things, and this action is just one of the many initiatives FDA is taking to meet its public health responsibility. 

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Getting Importers’ Pulse About Food Safety Plans

By: Michael R. Taylor

My team and I took to the road again recently to reach out to the people who will be most affected by the food safety rules that FDA has proposed this year.

We traveled to Long Beach, Calif. – one of the world’s busiest ports – on Oct. 22 and 23 for a public meeting on the two rules that FDA proposed in July to help prevent contaminated foods from ever reaching U.S. ports. These rules – Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors - would make importers more accountable for food safety and would strengthen our ability to monitor foreign food producers.

Members of the import community and food industry attended a public meeting on proposed rules designed to keep imported foods safe.

Earlier this fall, we had our first public meeting on the proposed import rules in Washington, D.C., that was attended by a diverse audience, including consumer and public policy representatives. In Long Beach, the audience was predominantly members of the import community and food industry around the world – including public and private officials from Japan, Thailand, Mexico, Canada and Barbados. Global impact was a thread that wove through all the discussions.

We were very pleased to have with us Sandra Schubert, undersecretary for the California Department of Food and Agriculture, who emphasized the importance of these rules to a large importing and exporting state like California. Across the country, the states will play a very important role in making the food-safety rules a reality.

We learned how the complexity of the global food supply chain could make implementation a challenge. For example, the owners of specialty food stores may have a comparatively small volume of food, but they use many different suppliers around the world. (One Italian foods retailer said that he uses 38 different suppliers in Italy.) They are concerned about the difficulty of requiring all of their small-scale suppliers to verify that the foods are produced in a manner consistent with U.S. standards.

Their complaint is similar to those voiced by small farmers facing a proposed rule that would create new safety standards for the produce industry. They too are afraid of being overwhelmed by logistics and expenses that could put them out of business. As with the produce rule, there are exemptions for small businesses and suppliers. However, some of the specialty importers feel that those exemptions should be expanded.

I was impressed that many of those who spoke at the meetings are thinking ahead to the nuts and bolts of implementation. They asked, however, how we will keep the playing field level – holding all importers and exporters to the same standards. They’ll be at a financial disadvantage if they’re following the rules and others aren’t.

We’ll consider that, and we’ll keep talking. There is clearly no “one size fits all” solution. We want to meet our safety goals with practical, feasible regulations that will work across the wide diversity of food operations.

From Long Beach we drove north to Bakersfield, where we met with growers to discuss the proposed produce regulations. These farmers produce an incredible diversity of crops, including citrus fruits, table grapes, almonds, carrots, leafy greens, green peppers and many more.

We learned a lot in this visit to California. Everything that we heard will be carefully considered as we work on the final version of these rules.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.

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