FDA 2015: A Look Back (and Ahead) – Part 1: Medical Product Innovation

By: Stephen M. Ostroff, M.D.

As the year draws to a close, I want to reflect on FDA’s many accomplishments in these previous 12 months, the last nine of which it has been my pleasure to serve as Acting Commissioner. FDA has broad responsibilities – indeed, we are tasked with overseeing products that account for about 20 cents of the consumer dollar — so we work on a wide range of topics in any given year. In this and two additional blog posts over the coming days I’ll cover some of our key accomplishments in 2015. Each blog will examine a different area of FDA’s work. This first post will focus on medical product innovation – our role in making safe, effective and innovative products available to patients who need them.

Acting FDA Commissioner, Stephen Ostroff, M.D.Scientific advances and unprecedented innovation in the sectors we regulate make it an exciting time to work at and lead FDA. To protect and promote the public health our regulatory decision-making must be nimble and current, adapted to the forward march of science.

One measure of our success is revealed in a study released in September by FDA’s independent Science Board. Mission Possible: How FDA Can Move at the Speed of Science documents the Agency’s progress and transformation over the last eight years, dating from a time when FDA had been increasingly unable to meet its scientific responsibilities due to chronic underfunding, a loss of scientific expertise, and the need to implement new legislative mandates without the resources to do so. In stark contrast, today FDA’s regulatory science enterprise is much stronger, which better allows us to effectively fulfill our commitment to protect the public health. The report also provides recommendations for future investments in regulatory science to assure FDA keeps pace with emerging trends in science and technology.

Medical Product Approvals

For many years now, we’ve strived to modernize and streamline the regulatory process along the entire development, review, and product oversight continuum.

The success of these changes is shown by the large number and wide variety of medical products we’ve approved across our medical product centers. So far this year, we have approved more than 40 novel drugs, including four new treatments for patients with multiple myeloma, two new drugs for patients with heart failure, and another robust year of approvals of drugs for rare or “orphan” diseases. We’ve approved several important vaccines, including one for serogroup B meningococcal disease, the first seasonal influenza vaccine to contain an adjuvant (intended for people 65 years and older), and a new indication for anthrax vaccine to prevent disease following exposure to anthrax – the first vaccine to receive an approved indication based on the Animal Rule (which provides for testing certain products on animals alone). And we saw the approval of several innovative devices that will make a positive difference in the lives of patients, including a device that extends the survival time of patients with brain cancer, and a transcatheter pulmonary valve that can be placed in certain patients with congenital heart disease, without requiring open heart surgery.

Our success is also measured in our speed and efficiency of approvals. The U.S. continues to lead the world in approving novel drugs first. And we’ve seen important progress in our device review program. Our average time to reach decisions on PMAs has dropped 36 percent since 2009. And not since 2001 FDA has approved as many medical devices under the original premarket approval pathway and the panel track supplement pathway (for significant changes to a PMA device) as we did this year – 58 as of December 14th.

The number of approvals, and the agency’s ability to review products efficiently, continue to be buoyed by FDA’s expedited development and review programs. When we talk to drug and device makers at the early stages of development, and apply better regulatory science to our ultimate review of their applications, products that are likely to fail are weeded out, allowing manufacturers to focus on those more likely to attain approval.

Most importantly, enhanced flexibility and an efficient approval process have come without lowering our gold standard of safety and efficacy. At the end of the day, innovative therapies are only helpful to patients if they work and are demonstrated to be safe. So it is imperative that we ensure the right balances among patient access, sound science, and safe and effective products.

Amplifying the Patient Voice

Enhancing the patient’s voice in the medical product approval and evaluation process is an important emerging area of product development, which we have embraced in a number of ways.

Those living with a disease are in a unique position to provide essential insights about life with their condition, its severity, and the adequacy of treatment options. We also recognize patients and caregivers have their own perspectives on benefits and risks of medical products, and we believe this input should be considered during regulatory decision-making.

Our Patient-Focused Drug Development initiative is a five-year effort that includes holding at least 20 public meetings in different disease areas. Seventeen of those meetings have occurred and seven more are being scheduled. After receiving patient input during each meeting and in the agency docket, FDA develops a Voice of the Patient report that is then posted on our website. In a complementary effort, our medical device program launched the Patient Preference Initiative. It includes studies to evaluate patient preferences in medical devices, and publishing of a draft guidance that describes how patient tolerance for risk and perspective on benefit, in addition to clinical data and other information, may be considered in FDA’s benefit-risk assessments for certain medical devices. This year FDA approved a weight loss device treatment, and our decision was informed in part by data from a patient preference study funded and co-designed by the Agency.

In September 2015, FDA announced our first-ever Patient Engagement Advisory Committee, which will provide advice on complex issues related to the regulation of medical devices and their use by patients. This Advisory Committee will help ensure the needs, experiences, and perspectives of patients are considered in our work and incorporated in our decision-making.

Biosimilars

Five years ago Congress authorized an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. The intent was to create greater competition in the medical marketplace that would not only increase treatment options for patients, but also lead to less expensive alternatives to comparable products. FDA has been developing its biosimilar program since then, an effort which led to the approval of the first biosimilar in March. And there are more applications in the pipeline. To prepare, FDA has produced a variety of guidances in this area, including the recent draft guidance on how these biosimilars should be named.

Advancing the Development of Next Generation Sequencing Tests and Strengthening Clinical Trials

Our strengthened focus on regulatory science is helping to drive innovation. One illuminating example is our growing ability to apply the sophisticated technologies of next generation sequencing and precision medicine.

FDA today is better prepared and more engaged than ever in facilitating the development of these new technologies (as well as new uses for older technologies), while assuring they are safe and effective. These efforts help to achieve more precise diagnosis or treatment, through the development and review of state of the art diagnostics that use genetic information to make therapies more targeted.

We continue to move forward on the White House’s Precision Medicine Initiative to advance biomedical understanding by leveraging genomic advances, health information technologies, and new methods of analyzing large volumes of data. Just this month, we launched FDA’s precisionFDA web platform, a cloud-based portal that will allow scientists from industry, academia, government and other partners to come together to foster innovation and develop the science behind next-generation sequencing and help us design treatments tailored to a person’s individual genetic blueprint.

And we also are working to refine clinical trial design and statistical methods of analysis to create more efficient studies with smaller patient populations, more focused therapies, and better outcomes. For instance, we continue to support collaborative efforts in clinical trials, such as the I-SPY trials (for breast cancer) and the Lung-MAP protocol (for lung cancer).

It’s impossible to capture in one blog post the many ways that FDA’s focus on regulatory science is helping drive innovation and speed the discovery, development, and delivery of medical products to prevent and cure disease and improve health. We are immeasurably proud of these accomplishments, which provide a strong foundation for continuing success.

Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs

FDA Invites Patient Organizations to Take a Place at the Podium

By: Theresa M. Mullin, Ph.D.

Sometimes, the most valuable thing we can do as regulators at FDA is simply to listen. I’m reminded of that each time we hold a public meeting as part of the Patient-Focused Drug Development (PFDD) program.

Theresa MullinWe began PFDD to more systematically obtain the patient perspective on certain diseases and their treatments. The effort is part of an FDA commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).

Each public meeting is focused on a specific disease area. Our commitment is to gain perspectives on at least 20 disease areas by the end of FY 2016. And having already held 17 meetings to hear from patients with diseases as varied as breast cancer, fibromyalgia and sickle cell disease, we are well on our way.

What have we learned so far? For one, thanks to PFDD we now have even more first-hand knowledge from those most affected by the diseases. We have heard directly from patients, their families, and care givers about the symptoms that matter most to them; the impact the disease has on patients’ daily lives; and their experiences with currently available treatments. For example, we’ve learned that for diseases that are progressive and severely disabling, patients and their families may consider an “ideal” treatment to be one that at minimum can halt disease progression.

These perspectives are critical to helping us understand the context in which we are making regulatory decisions for new drugs. And they’ll have ramifications for years to come. We believe that the long-term impact of PFDD will be better, more informed FDA decisions and oversight both during drug development and during our review of a marketing application.

Expanding the Benefits of the PFDD Meeting Model

This is a priority for FDA. To that end, we’ve committed to hold meetings for at least 20 disease areas, and are currently planning to hold 24 different disease-focused meetings by the end of FY2017, exceeding our commitment. We recognize, however, that there are many more disease areas than can be addressed in the planned FDA meetings where drug development and regulatory decision making would benefit from a meeting focused on obtaining the patient’s perspective.

To help expand the benefits of FDA’s PFDD initiative, FDA invites the independent efforts of patient organizations to identify and organize externally-led patient-focused collaborations to generate public input on other disease areas, using the process established through Patient-Focused Drug Development as a model. Given the tremendous number of diseases affecting the U.S. patient population and the effort required to conduct a successful PFDD meeting, externally led PFDD meetings should target disease areas where there is an identified need for patient input on topics related to drug development.

We recommend that patient organizations interested in conducting an externally-led PFDD meeting submit a letter of intent so that we are aware of their plans. Submission details and more information on considerations to take into account are outlined on FDA’s website.

Please note that an externally led PFDD meeting and any resulting products, such as surveys or reports, will not be considered FDA-sponsored or FDA-endorsed. And while we can’t guarantee FDA’s specific involvement at every meeting, FDA will be open to participating in a well-designed and well-conducted meeting.

And as the number of patient-focused forums continues to grow, we at FDA will continue to listen and look forward to gaining the additional insights that only patients, their families, and care givers can provide.

Theresa M. Mullin, Ph.D., is Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research

FDA Enforcement: Protecting Consumers and Enhancing Public Confidence

By: Howard Sklamberg, J.D. and Michael R. Taylor, J.D.

Under the Federal Food, Drug, and Cosmetic Act, companies producing food, including dietary supplement products, for American consumers have a legal responsibility to make them safe. Most companies take this responsibility seriously. FDA will work collaboratively with companies that are making a good faith effort to produce safe products and meet regulatory requirements.

Howard Sklamberg

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

But when companies fail to meet their responsibility and violate the law in a way that jeopardizes public health, FDA can—and will—move decisively. This fall, for example, a federal court case in New Jersey illustrates the careful field work, close teamwork, and skillful investigation that are hallmarks of FDA criminal enforcement, which plays a vital role in food and dietary supplement safety.

The case involves Raw Deal, Inc., a manufacturer of dietary supplements based in Flanders, N.J. On September 9, Raw Deal’s owner and president, Barry Steinlight, pled guilty to one count of conspiracy to commit wire fraud involving a scheme to introduce adulterated and misbranded products into interstate commerce. Steinlight was sentenced to 40 months in prison and ordered to forfeit $1 million in profits from the fraudulent scheme.

Then, today the company’s former executive vice president, Catherine Palmer, was sentenced to a year’s probation and a criminal forfeiture of $100,000, after she pled guilty to obstructing an FDA investigation.

Last year, we wrote about federal-court convictions in the Peanut Corporation of America (PCA) case involving Salmonella-tainted peanuts and peanut products. In that case, two former officials of, and one broker for, PCA were prosecuted for practices that led to a deadly 46-state outbreak of Salmonella poisoning in 2009.

Michael R. Taylor

Michael R. Taylor, J.D., FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Today, we are highlighting the Raw Deal prosecution, which demonstrates our enforcement work in the dietary supplement field. The convictions arose from illegal practices by the firm, which included manufacturing adulterated and misbranded products by using fillers to cut costs, reusing returned and contaminated products, and falsifying batch records and certificates of analysis.

This story begins more than four years ago. Over the course of those years, FDA undertook a number of enforcement activities before criminal charges were filed by the U.S. Department of Justice:

  • In August 2011, FDA’s Office of Criminal Investigations (OCI), now headed by Director George Karavetsos, received an anonymous complaint that Raw Deal was manufacturing dietary supplements with fillers such as wheat-based products and the food additive Maltodextrin. The complainant also informed OCI that the manufacturer resold returned products that contained such contaminants as E. coli bacteria, lead and mold.
  • During the OCI investigation, FDA’s Office of Regulatory Affairs’ New Jersey District Office received four anonymous letters that described Raw Deal’s adulteration scheme, including the creation of false certificates of analysis.
  • The District Office conducted a compliance inspection and found that the manufacturer substituted ingredients without informing customers of the presence of fillers. As a result, the District Office issued Raw Deal a Warning Letter citing misbranding and adulteration violations.
  • OCI later determined that Raw Deal did not heed this warning and instead continued misbranding and adulterating its products. OCI then obtained and executed a search warrant at the manufacturing facility, with some of the samples collected subsequently revealing the presence of Salmonella, a bacterium frequently associated with foodborne illnesses.
  • This resulted in a Class I recall of certain Raw Deal products in March 2014. This recall classification means the products could cause serious health problems or death.

This case is just one example of FDA enforcement in action. Companies are given the opportunity to correct violations but if they don’t, there are serious consequences. Indeed, during the past two years, FDA criminal enforcement has resulted in 407 cases opened, 348 arrests, 305 convictions, and $694,131,579 in fines and restitutions.

Of note in this case is an excerpt from U.S District Court Judge Esther Salas’ remarks at Steinlight’s sentencing hearing:

“There is nothing more sacred than consumers having some peace of mind that people who are selling these supplements are doing it the right way, and are abiding by the laws and regulations that are put forth to protect the consumer…and my sentence has to be one that promotes respect for the law. Because what the FDA does is so critical…they are making sure that the products that we consume and the products that we use are safe for consumption, are safe for usage. And I am going to sentence you to a sentence, sir, that continues to give them the teeth they need, the power they need, to send a message to our society.”

Criminal enforcement actions protect consumers by punishing violators and deterring bad behavior by others. Strong enforcement helps industry too – by maintaining a level playing field for the production of safe foods and products.

FDA is strongly committed to working with companies that take their safety responsibilities seriously – and equally committed to dealing strongly with those that don’t.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

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

FDA Launches precisionFDA to Harness the Power of Scientific Collaboration

By: Taha A. Kass-Hout, M.D., M.S. and Elaine Johanson

Imagine a world where doctors have at their fingertips the information that allows them to individualize a diagnosis, treatment or even a cure for a person based on their genes. That’s what President Obama envisioned when he announced his Precision Medicine Initiative earlier this year. Today, with the launch of FDA’s precisionFDA web platform, we’re a step closer to achieving that vision.

Taha Kass-Hout

Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics.

precisionFDA is an online, cloud-based, portal that will allow scientists from industry, academia, government and other partners to come together to foster innovation and develop the science behind a method of “reading” DNA known as next-generation sequencing (or NGS). Next Generation Sequencing allows scientists to compile a vast amount of data on a person’s exact order or sequence of DNA. Recognizing that each person’s DNA is slightly different, scientists can look for meaningful differences in DNA that can be used to suggest a person’s risk of disease, possible response to treatment and assess their current state of health. Ultimately, what we learn about these differences could be used to design a treatment tailored to a specific individual.

The precisionFDA platform is a part of this larger effort and through its use we want to help scientists work toward the most accurate and meaningful discoveries. precisionFDA users will have access to a number of important tools to help them do this. These tools include reference genomes, such as “Genome in the Bottle,” a reference sample of DNA for validating human genome sequences developed by the National Institute of Standards and Technology. Users will also be able to compare their results to previously validated reference results as well as share their results with other users, track changes and obtain feedback.

Elaine Johanson

Elaine Johanson, precisionFDA Project Manager.

Through such collaboration we hope to improve the quality and accuracy of genomic tests – work that will ultimately benefit patients.

Over the coming months we will engage users in improving the usability, openness and transparency of precisionFDA. One way we’ll achieve that is by placing the code for the precisionFDA portal on the world’s largest open source software repository, GitHub, so the community can further enhance precisionFDA’s features.

precisionFDA leverages our experience establishing openFDA, an online community that provides easy access to our public datasets. Since its launch in 2014, openFDA has already resulted in many novel ways to use, integrate and analyze FDA safety information. We’re confident that employing such a collaborative approach to DNA data will yield important advances in our understanding of this fast-growing scientific field, information that will ultimately be used to develop new diagnostics, treatments and even cures for patients.

Taha A. Kass-Hout, M.D., M.S., is FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics. Elaine Johanson is the precisionFDA Project Manager.

What We Mean When We Talk About Data

By: Robert M. Califf, M.D. and Rachel Sherman, M.D., M.P.H.

Robert M. Califf, M.D., MACC, FDA's Commissioner of Food and Drugs

Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug Administration

Medical care and biomedical research are in the midst of a data revolution. Networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and smartphones and other personal devices together comprise an immense new set of sources for data about health and healthcare. In addition, these “real-world” sources can provide data about patients in the setting of their environments—whether at home or at work—and in the social context of their lives. Many researchers are eager to tap into these streams in order to provide more accurate and nuanced answers to questions about patient health and the safety and effectiveness of medical products—and to do so quickly, efficiently, and at a lower cost than has previously been possible.

But before we can realize the dramatic potential of the healthcare data revolution, a number of practical, logistical, and scientific challenges must be overcome. And one of the first that must be tackled is the issue of terminology.

Defining Terms

Although “data,” “information,” and “evidence” are often used as if they were interchangeable terms, they are not. Data are best understood as raw measurements of some thing or process. By themselves they are meaningless; only when we add critical context about what is being measured and how do they become information. That information can then be analyzed and combined to yield evidence, which in turn, can be used to guide decision-making. In other words, it’s not enough merely to have data, even very large amounts of it. What we need, ultimately, is evidence that can be applied to answering scientific and clinical questions.

So far, so good. But what do we mean when we talk about “real-world data” or “real-world evidence”?

Rachel Sherman

Rachel Sherman, M.D., M.P.H., FDA’s Associate Deputy Commissioner for Medical Products and Tobacco.

Clinical research often takes place in highly controlled settings that may not reflect the day-to-day realities of typical patient care or the life of a patient outside of the medical care system. Further, those who enroll in clinical trials are carefully selected according to criteria that may exclude many patients, especially those who have other diseases, are taking other drugs, or cannot travel to the investigation site. In other words, the data gathered from such studies may not actually depict the “real world” that many patients and care providers will experience—and this could lead to important limitations in our understanding of the effectiveness and safety of medical treatments. Clinicians and patients must be able to relate the results of clinical trials—studies that are done in controlled environments with certain patient populations excluded and which may therefore be challenging to generalize—to their own professional and personal experiences. It seems straightforward, then, to think that studies including a much fuller and more diverse range of individuals and clinical circumstances could ultimately lead to better scientific evidence for application to decisions about use of medical products and healthcare decisions.

But “real-world evidence” has its own issues that must be understood and dealt with carefully. First of all, the vague term “real-world” may imply a closer relationship with the truth—that the real-world measurement is preferable to one taken in a controlled environment. For example, is “real-world” blood pressure data gathered from an individual’s personal device or health app better (e.g., more reliable and accurate) than a blood pressure measurement from a doctor’s office? It could be, because a patient’s blood pressure might be uncharacteristically elevated during a visit to the physician. But at the same time, do we know enough about the data gathered from the patient’s personal device—how accurate is it? Is the patient taking their own blood pressure correctly? What other factors might be affecting it?—to use it for generating evidence? Already we are being reminded of the complexities of potentially relying on data that were gathered for purposes other than the ones for which they were originally intended.

In most cases “real-world evidence” is thought of as reflecting data already collected, i.e., epidemiologic or cohort data that researchers review and analyze retrospectively. Also of interest is whether randomized trials can be conducted in these “real-world” environments. In considering comparisons of treatments, one must always consider the possibility that the treatments were not assigned randomly, but reflected some relevant patient characteristic. This is, of course, the reason for doing randomized clinical trials.

Better Terms for Complex Subjects

There is little doubt that the new sources of data now being opened to researchers, clinicians, and patients hold enormous potential for improving the quality, safety, and efficiency of medical care. But as we work to understand both the promise and pitfalls of far-reaching technological changes, we need a more functional vocabulary for talking about these complex subjects, one that allows us to think about data, information, and evidence in ways that capture multiple dimensions of quality and fitness for purpose (e.g., for appropriate use in regulatory decision making). The incorporation of “real-world evidence”—that is, evidence derived from data gathered from actual patient experiences, in all their diversity— in many ways represents an important step toward a fundamentally better understanding of states of disease and health. As we begin to adapt “real-world data” into our processes for creating scientific evidence, and as we begin to recognize and effectively address their challenges, we are likely to find that the quality of the answers we receive will depend in large part on whether we can frame the questions in a meaningful way.

Robert M. Califf, M.D., previously FDA’s Deputy Commissioner for Medical Products and Tobacco, became FDA’s Commissioner of Food and Drugs on Feb. 25, 2016.

Rachel Sherman, M.D., M.P.H., is FDA’s Associate Deputy Commissioner for Medical Products and Tobacco.

Lessons Learned in Mexico about Food Safety – And Tomatoes

By: Stephen M. Ostroff, M.D.

En Español

As my colleagues at FDA can attest, I like to grow tomatoes in the summer. I often bring portions of the harvest to the office each week of the growing season. Though the total volume is modest, I still like to think of myself as an environmentally conscious and responsible “farmer.”

Group photo of FDA and Mexico Officials and Tomato Growers

From left to right:
Rafael Ávila Julio Mexico-SENASICA-Branch Chief)
Joaquín Rivera Quiroz (Mexico-SENASICA-International Affairs)
SENASICA staff member
Edmundo Garcia (FDA-Regional Director for Latin America)
Mary Lou Valdez (FDA-Associate Commissioner for International Programs)
Stephen Ostroff (FDA- Acting Commissioner)
Sandra Cruz (FDA- Assistant Regional Director for Latin America)
Silvia Rojas Villegas ( Mexico- SENASICA- Director for Food Safety, Aquaculture, and Fisheries)
Jorge Martínez Lambarry (Mexico- General Director Binatur Invernaderos)
Angel Covarrubias Domínguez (Mexico – SENASICA’s staff)
Selma Koekoek (Food Safety Manager – Binatur Invernaderos).

So I was glad to spend some time on food safety issues last month while in Mexico attending the 10th International Summit of Heads of Medicines Regulatory Agencies. In addition to summit activities, I spent time with FDA staff in our Latin America Office and with our regulatory counterparts in Mexico charged with keeping foods safe. In the process, I gained a new appreciation for the partnership we have with Mexico to enhance food safety and to minimize the potential for contamination of fresh produce.

Which brings me back to tomatoes.

Representatives of the Mexican National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) accompanied me and other FDA staff on a tour of Bionatur Invernaderos de Mexico, a state-of-the-art tomato-growing operation located in Jocotitlan Estado de Mexico, about 75 miles outside of Mexico City.

While most people think of growing tomatoes as an activity that requires soil, tomatoes can also grow using an alternative substrate and the addition of water, sunshine, and nutrient solutions. Bionatur Inveraderos is among the largest users of this technology, known as hydroponics, in the world. It’s an enormous, state-of-the-art operation, with eight 25-acre greenhouses on the 200-acre farm. And the results are very impressive, with row after row of enormous plants that dwarf my back-deck efforts.

Hydroponic tomatoes

Rows of tomatoes at Bionatur Invernaderos de Mexico, a state-of-the-art tomato-growing operation located in Jocotitlan Estado de Mexico, about 75 miles outside of Mexico City.

For me, there’s a real value to FDA visiting farms of all kinds to see first-hand the importance growers place on producing safe fruits and vegetables and the pride they have in their work, no matter what the size of the operation. Just as in the United States, produce is grown on all different kinds of farms in Mexico, from those using the latest technology to traditional operations that have been in hard-working families for generations. What the U.S. and Mexico also have in common is our mutual commitment to the safety of produce grown on our nations’ farms, which is especially important as the food supply continues to become more global.

For example, while the United States is a leading producer of tomatoes, Mexico is currently the 10th largest in the world. And in the last decade, tomato trade between the U.S. and Mexico has grown considerably — and is likely to continue to expand as global supply chains further diversify.

In light of these trends, assuring the safety of these imports is paramount. That’s why we work closely with our Mexican food safety counterparts: SENASICA and the Federal Commission for the Protection of Sanitary Risk (also known as COFEPRIS). Last year, our three agencies signed The Produce Safety Partnership, which specifically aims to promote the safety of fresh and minimally processed agricultural products in both countries.

SENASICA has a voluntary Risk Reduction System for Contamination (SRRC) program to ensure that fruits and vegetables grown in Mexico are produced in optimal sanitary conditions to reduce the risk of contamination.

Food safety requires everyone’s participation — including farms, facilities, regulatory agencies, and consumers. As we implement the FDA Food Safety Modernization Act (FSMA), we are working closely with our Mexican regulatory counterparts, as well as other nations and international stakeholders, to make sure that they have the understanding, information, and training necessary to meet these important new food safety standards.

FDA’s Latin America Office, with staff located in San Jose, Costa Rica; Santiago, Chile; and Mexico City, will be instrumental in this FSMA outreach as we rely heavily on the Latin American region to ensure the availability of fresh produce year round.

Two FSMA rules that became final this month are particularly important to Mexican farmers growing produce destined for American consumers. The Produce Safety rule establishes science-based safety standards for both domestic produce farms and those in other countries that export to the U.S. And the Foreign Supplier Verification Programs (FSVP) rule requires importers to ensure that their foreign suppliers meet U. S. safety standards.

It is clear to me that Mexico also shares another quality with the U.S. and other nations: It has the academic capital and capacity to engage in both high tech and traditional farming, and to successfully meet these new safety standards designed to prevent foodborne illness.

While there are differences in our systems, technologies, and environments, the U.S. and Mexico both want consumers to be confident in the safety of their food. By working together, we can achieve that goal.

Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs