Importing Drugs to Address Shortages

By: Capt. Valerie Jensen, R.Ph.

Patients deserve and expect medicines that are available when they need them. The FDA works hard to prevent shortages of the medicines patients trust and rely on, and we do all we can to mitigate them whenever necessary. 

Over the past several months, the FDA has been working to resolve the shortages of injectable drugs used to make total parenteral nutrition, or TPN. These shortages are greatly affecting children’s hospitals. They rely on this treatment for vulnerable patients who cannot get the nutrition they need through eating and must receive it intravenously to survive. 

It’s heartbreaking for us to hear that these hospitals across the country are struggling to provide the proper nutrition in the face of these shortages. As a mom, my heart goes out to the parents of these infants and children who are struggling to survive. 

When my team and I first learned that American Regent/Luitpold, the U.S. manufacturer that makes many of the TPN components, was going to voluntarily shut down to resolve its quality issues, we determined which drugs were made only by American Regent and which ones were also made by other manufacturers. For those that had other manufacturers, we reached out to those firms to see if they were able to increase their production. However, while the manufacturers were able to do so, they would not be able to meet the total supply needs. 

Shortages of these drugs – such as the trace elements injection, sodium phosphate, potassium phosphate, calcium, zinc and other IV nutrition drugs – ­are particularly challenging. To supply them to the entire country, it was clear that our best option was to ask a foreign company to dramatically increase its production. Immediately, we began working with our regulatory counterparts around the world to search for a foreign manufacturer that was willing and able to supply products. 

Once we identified the potential manufacturers who were willing and able to help with these shortages – including Fresenius Kabi USA, LLC (FK USA) – we worked to ensure that the drugs are quality products and would not pose undue risk to U.S.patients. We reviewed many aspects of the companies’ processes and operations, including: 

  • the manufacturing practices at the manufacturing facilities, as well as at the facilities where the active pharmaceutical ingredients, or APIs, are produced;
  • the history of inspections of those facilities from our own inspections or those of  our regulatory counterparts; and
  • the sterilization methods used for injectable drug products to ensure they met FDA standards. 

We then met with FK USA and the other firms to determine: 

  • a distribution and shipping plan;
  • how adverse events will be reported to FDA;
  • how an outline for a Dear Health Care Provider letter, which highlights important information for doctors and pharmacists, will be structured; and
  • product labeling. 

While this might seem like a long road to take in resolving a shortage, it is an important process to protect the health of patients during a shortage. We expect these importations to address the current supply disruption over the coming weeks and we will remain vigilant in monitoring the supplies of these drugs until patient needs are fully met.   

Capt. Valerie Jensen, R.Ph., is the Associate Director of the Drug Shortages Program in FDA’s Center for Drug Evaluation and Research

Looking for Answers? Helping You Find Them is My Job

By: Anitra Brown-Reed

People call me every day in my Philadelphia office wanting FDA’s help on a wide variety of issues. My job as a Public Affairs Specialist and Small Business Representative is to help them find an answer.

For example, a mother once called to figure out the best way to sell the “great,” and nutritious, baby food she makes from her home kitchen. Some enthusiastic pet owners say they make terrific treats for dogs and cats; they want to know if they can market the pet food to others. On any given day, I could get a call about almost anything, like the one from a person who wants to open a restaurant serving ostrich and buffalo meats.

But most of my time is spent talking and listening to small business owners who need some direction and assistance.

Whatever the questions, my job is to help get answers. I’ve listened, talked, e-mailed and assisted hundreds of people — everyone from small business owners who want help understanding the law to people who are building dreams right out of their kitchens.

I am not alone. FDA’s Small Business Representatives and Public Affairs Specialists work closely with small business contacts in the agency’s different centers. And our Small Business Guide on FDA.gov can direct you to the right person or resource to address your unique issue.

This entire effort is about helping small companies achieve their business aims while ensuring that FDA accomplishes its public health mission.

In my little corner of the world, I am honest when people call. If they don’t seem to know where to start, the first step for me is to level with them. Sometimes that means telling them, “The FDA is the wrong place for you.” FDA may not regulate the product, and if not, I’ll do my best to point small businesses to the right agency or resource anyway.

Sometimes, I need to remind people that there are very important facts to consider before going down the road—to make baby food or other types of FDA-regulated products—and that there are many things the FDA regulates, especially if there is any potential risk to public health.

Most of the time, I simply try to put people on the right path. Someone may come to me having already done research, but may not know how to resolve remaining issues. They could be small business owners who are thinking about creating new packaging or manufacturing a new product.

Whatever the reason, they want to know what steps to take and where to go. I listen and try to understand their goals as well as their challenges; then I connect them with resources, including the right people at the FDA.

It’s not complicated, but it is important. I’ve been at the FDA for 25 years, which includes time spent as an investigator. So I know both the agency and the real world, and I’ve dealt with a lot of people with all sorts of questions who simply want to connect with a real person.

I am here to help. That’s what my role at FDA is all about. Let me know if you have any questions.

Anitra Brown-Reed is a Public Affairs Specialist in Philadelphia

Hurricane Season Is Here – Be Prepared

By: Pat El-Hinnawy

Bottles of water? Check.
Food for the family? Check.
Dad’s blood pressure medicine? Check.
Grandma’s heart monitor? Check.

It’s hurricane season again. 

Anyone who lived through or watched Hurricane Sandy last year knows the horrific consequences that can follow major storms.  

As we enter the 2013 Atlantic hurricane season, keep in mind that good planning can help ease the burden on you and your family if and when bad weather comes your way.  

And FDA can help. To make sure you have the products you will need to get through a hurricane and its aftermath — including FDA-regulated products such as your food, medicines and medical equipment, — we have prepared a simple checklist.  It shows what steps to take to protect those products you have and to make the right choices as you prepare for this year’s bad weather. The Federal Emergency Management Agency (FEMA) says it’s always best to start with a plan and an emergency kit. 

Your emergency kit should include enough food, water, medical supplies, pet food and supplies, and equipment to get you through the first 72 hours after a big storm or other natural disaster. 

For more tips on how to protect your FDA-regulated items, see FDA’s Hurricane Safety Checklist

After the storm has passed, it’s time to pitch in and put your homes and neighborhood back in working order. In a similar way, our field investigators contact local regulated firms that produce or process food, medicines, medical equipment, vaccines and other medical supplies. 

We work with those firms to make sure their products can still meet FDA’s standards before they’re sent to market. For foods, this means the products are safe, wholesome and correctly labeled. For medical products (medicines, medical equipment, vaccines, etc.) it means they are safe and effective. 

Nathan Beck and Valerie Hall are just two of the many FDA specialists working behind the scenes. They draw on an impressive array of data and equipment to quickly develop maps using FDA’s Geographic Information System (GIS). These maps show field investigators how to get around flooded areas to reach industries affected by a hurricane or other emergency. And they provide crucial information to emergency managers coordinating FDA activities.

Many specialists at FDA headquarters also work to support and coordinate the work in the field. They monitor all affected areas across the country to make sure that our investigators have what they need to get the job done. 

We also regularly train for emergencies, and we practice responding to a wide range of incidents, including hurricanes. Recently, we held a hurricane season training session for more than 200 staffers from around the country. 

No one can control where or when hurricanes may strike.  But at the FDA we can, and do, prepare for major storms – and so can you. 

Pat El-Hinnawy is a Public Affairs Specialist in FDA’s Office of External Affairs

When Regulators are Ignored

By: John Roth

In my last FDA Voice post, I explained the Office of Criminal Investigation’s (OCI) role within FDA as using our top-flight federal agents to protect the public health in unique ways. Not every one of our cases involves undercover agents investigating shadowy overseas drug counterfeiters. Sometimes, illegal behavior leads us to high-profile instances of non-compliance right here in the United States.

Now, the good news is that the vast majority of the FDA-regulated entities respond to FDA’s ordinary regulatory tools. The concerning news, however, is that lapses in compliance do occur and the criminal remedy is available to gain compliance for that small portion of the industry that fails to respond to ordinary regulatory tools. 

Before selecting that remedy, OCI will look to see whether the entities have demonstrated a resistance to other regulatory efforts, including requests for voluntary cooperation and FDA formal warning letters or inspection reports, and instances in which entities fail to comply with judicial orders. We are particularly sensitive to circumstances in which it appears that the regulated entity engages in fraud or other deceptive conduct, either in relation to the FDA or the public at large.  

One area of particular OCI focus is the deceptive conduct by those who manufacture and market pharmaceuticals. It’s nothing less than a life-threatening problem for millions of Americans who rely upon safe medications. 

Moreover, it’s a category that has involved our OCI professionals in a number of fairly high-profile criminal prosecutions involving a range of criminal behavior. Take the investigation of Abbott Laboratories, for example. Abbott applied for FDA approval to use its drug Depakote for additional indications, including treating dementia and schizophrenia. Healthcare providers using the drug for approved uses were required to balance the potential benefits against the significant risks associated with the drug. Indeed, the drug carried three “Black Box” warnings — the most serious warning the FDA can require — as a result of the adverse side effects associated with the risk of the drug.  

The FDA denied the application because even after a number of clinical trials, Abbott could not demonstrate that Depakote was effective for the new indications. Notwithstanding the FDA rejection, Abbott trained its sales force to aggressively market Depakote for dementia and schizophrenia, claiming advantages over several competing products, and failing to disclose the previous negative studies. Moreover, after two of Abbott’s own studies failed to show that Depakote was effective in treating patients with dementia and schizophrenia, Abbott waited nearly two years to notify its own sales force about the study results and another two years to publish those results. Abbott ultimately pleaded guilty and paid $700 million to the U.S. in fines and forfeitures.  

A similar fact pattern occurred in the investigation into the biotechnology company Amgen. In that case, the manufacturer sought FDA approval for additional indications for its anemia drug Aranesp. The company wanted to add patients with chronic kidney disease or those receiving much larger, less frequent, doses of chemotherapy than those currently approved by the FDA for these patient populations. FDA rejected the application after determining that Amgen had failed to show that Aranesp was safe and effective for these expanded indications. 

Despite that decision, Amgen aggressively marketed the drug as more effective than its FDA-approved competitor for the unapproved indications. Amazingly, the Amgen sales force was trained to provide physicians with studies to demonstrate Aranesp’s effectiveness — studies that the FDA itself had rejected as insufficient to support the safety and efficacy of the drug for those off-label uses. And in fact, for one of the off-label uses — the treatment of anemia caused by cancer, irrespective of whether the patient had undergone chemotherapy — the FDA later determined that its use caused an increased risk of death and issued a “Black Box” warning on the drug for that use. Amgen ultimately agreed to pay the U.S. over $700 million in criminal and civil penalties to resolve these claims. 

In the next post, I’ll detail another aspect of OCI’s work. In the meantime, consider the nearly $1.4 billion in fines against these two firms – it’s an outcome that underscores the severity of the public health challenge and what happens when regulators are ignored. 

John Roth is Director of FDA’s Office of Criminal Investigations

Feeling Proud When Excellence is Noted—Twice

By: Lawrence Bachorik, Ph.D.

It’s always a good feeling when an outside organization recognizes an FDA employee for excellent performance in pursuit of our agency’s public health mission.  Recently, this was done by the Parenteral Drug Association (PDA) when it honored the work of two of my colleagues:  Kenneth Nolan and Kurt Brorson.  Ken received the PDA’s Distinguished Service Award, and Kurt the PDA’s Gordon Personeus Award. I ’m very pleased to congratulate both of them.

PDA is a global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. As such, its mission is similar to the public health goals pursued by Ken and Kurt in the course of their daily work for our agency.

Ken was given the Distinguished Service Award for special acts, contributions or service that contributed to the success and strength of PDA. As an FDA liaison to a large number of domestic and international trade associations and educational organizations, Ken advances FDA’s mission while helping these stakeholders prepare high value programs for their major meetings and conferences.

Ken responds to these groups’ requests for FDA speakers by using his many contacts throughout the agency to identify the most appropriate FDA experts on the desired topics. These presentations help increase the audiences’ understanding of FDA’s regulations, policies and initiatives designed to protect consumers and patients. Ken also often answers stakeholders’ questions about new regulations or requirements, explains their potential impact, and suggests how to best comply with them.

This is a two-way street. Ken’s work doesn’t help only scientific, industry, educational and trade groups better understand FDA’s requirements and priorities. The information he receives from these organizations provides our agency with important insights that help us do our job. We learn what’s on our stakeholders’ and potential partners’ minds, and how we can work together more effectively to advance the public health. 

For many organizations, Ken is the go-to guy they depend on to provide and explain information they need about FDA.

Kurt Brorson, Ph.D., received the award that commemorates Gordon Personeus, the past PDA president, one that also honors contributions of special importance to the association.

Kurt is one of FDA’s many highly accomplished scientists. A research biologist, he has done exemplary work and won numerous FDA awards in both the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. He’s also the author of more than 70 scientific journal articles and book chapters.

Kurt Brorson and Ken Nolan

For the past few years, Kurt has served as associate editor for the well-respected PDA Journal of Pharmaceutical Science and Technology. In addition, from 2005-2012, he was an active contributor to the PDA Biotechnology Advisory Board. His most notable achievement with PDA was a six-year, lab-based effort to establish the first nomenclature standards for virus filters, a key safety factor in the production of biotech medicines. Nomenclature in this case is a way to categorize virus filters according to their performance to ensure their consistent use across the industry.

It’s easy to get caught up in FDA’s efforts to ensure the safety, quality and effectiveness of a myriad of regulated products, and overlook our agency’s critical work of explaining what we are doing and how we can work together to better serve consumers and patients. The PDA awards are a prominent testimony to the essential role of this outreach, communication and cooperation, and its great contribution our mission. Ken and Kurt have made us proud, and they have my sincere congratulations.  

Lawrence Bachorik, Ph.D., is Assistant Commissioner for the Office of Communications in the Office of External Affairs

Science Is the Foundation of Food Safety at FDA

By: Michael R. Taylor, J.D.

Science is the foundation of everything we do at FDA to keep your food safe.

Michael R. Taylor, J.D.The Food Safety Modernization Act that President Obama signed into law in 2011 emphasizes prevention of foodborne illnesses. Margaret Hamburg, FDA’s commissioner, has made it our priority to base the agency’s regulatory decisions on sound, cutting-edge science.

We’re on the case.

The Office of Food and Veterinary Medicine (OFVM), which I am privileged to lead, is acting on a number of fronts to strengthen its scientific foundation. I am pleased to welcome David White as OFVM’s chief science officer and research director. Dr. White previously served as the director of the Office of Research at FDA’s Center for Veterinary Medicine. Palmer Orlandi Jr., another veteran scientist at FDA, is now our office’s senior science advisor.

We are marshalling our forces to work in the strongest, most effective way to keep the food that you eat, the food that you share with your family, free of dangerous levels of chemicals and bacteria like Salmonella, Listeria and E.coli.

We are prioritizing the work of our scientists in laboratories across the country based on which potential contaminants, such as disease-causing bacteria or chemicals, post the greatest risk to you.

Dr. White is the chairman of FDA’s Science and Research Steering Committee, which is made up of representatives from agency’s offices and center involved in food safety. These experts talk about research projects, before they even start, to ensure that everything we do furthers the goal of addressing the greatest threats to food safety.

FDA scientists are taking many different paths to that goal. Some respond to emergencies, working to rapidly identify the source of an outbreak. Others work longer term, exploring the genetic makeup of disease-causing bacteria and recovering information that will facilitate rapid identification in the future. Because science is always evolving and advancing, there are scientists who work to make sure that FDA has the most advanced tools with which to evaluate new technologies.

Scientists are developing new ways to detect bacteria like Salmonella in foods that include leafy greens, spices and pet foods. These tools will be invaluable surveillance tools that will help FDA prevent illness outbreaks. We are also exploring if certain bacteria would inhibit the spread of their disease-causing brethren if applied to tomatoes and other crops. This is just a sampling of the research that goes on every day at FDA.

FSMA gave FDA a mandate to implement a system that emphasizes prevention and prioritizes food safety challenges based on the risk they present to public health.

Our job is to make that mandate a reality. Part of the challenge is constantly evaluating our science and research agenda to make sure that it mirrors our public health priorities. These priorities change shape as bacteria evolve, new hazards emerge and new food-producing technologies are developed.

When you hear about science at FDA, there’s nothing theoretical about it. We are continually identifying the greatest threats to food safety and meeting them head on.

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

Track Our Success as We Implement New Law

By: Leslie Kux and Malcolm Bertoni

As we continue to implement the exciting new tools provided by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), we are inviting interested members of the public to use the Internet to track our progress.

Leslie Kux

FDASIA gave FDA new authorities to help FDA establish improved systems for combating drug shortages, protect the drug supply chain in an increasingly global market, and get generic medicines on pharmacy shelves and available to consumers more quickly. It is also encouraging companies to invest in discovering and developing new antibiotics, accelerate patient access to new medical treatments and breakthrough therapies, and promote the development of more treatments for children.

To track FDASIA’s progress, we leveraged an existing FDA web page that publishes pertinent information about a wide variety of FDA initiatives, and we added what we think are even better web tools for searching for specific details about a particular action.

The site currently shows that more than 30 of the tasks aimed at improving public health are completed. The site also lists numerous other steps involved in implementing the law and in each case provides a targeted completion date for the task and links to more information. Each task listed also includes a contact for more information or how to get answers to questions—either the e-mail address of an individual FDA employee or of an office specifically designated to handle that task.

Weaving the new authorities from the 140-page law into existing programs is a Herculean task, and doing it right takes time. We are committed to get the job done as quickly as possible while still making the best decisions that will serve the nation now and in the future.

Malcolm Bertoni

We established this web page to make that process transparent, and to encourage the input of those involved. Our immediate focus is on those provisions of the law that will have the greatest public health impact for which resources are in place, allowing us to act quickly.

We appreciate that some may be interested in viewing the nitty-gritty detailed listing of the many, complex actions involved in implementing FDASIA, and some may not. But we know the actions themselves will prove important to consumers and patients, who will ultimately benefit from the provisions of this new law.

Consumers and industry can find in-depth information, including fact sheets, news releases and technical information, at the FDASIA web page. FDASIA represents the potential for major improvements, and we are using everything at our disposal, to pursue the important goals it presents.

Leslie Kux is FDA’s Assistant Commissioner for Policy

Malcolm J. Bertoni is FDA’s Assistant Commissioner for Planning

Food Defense – What’s Your Plan?

By: Ted Elkin and Julia Guenther

Ted Elkin

While food safety—preventing unintentional contamination from sources likely to be found in the food chain—is a priority for FDA, so is food defense—protecting our food from intentional contamination by saboteurs, terrorists or other criminals.

Such an incident, should it occur, could have widespread public health and economic consequences. Therefore we work hard every day to minimize such risk.

In the last decade, FDA has provided various tools, resources, guidance, and information to the food industry to help them prevent intentional contamination. We work closely with state and local governments, as well as with the food industry, to better understand the vulnerabilities in the food system and identify the appropriate strategies to protect the food supply.

Julia Guenther

Recently, we released a new tool that will help the owners and operators of food facilities develop customized food defense plans to minimize the risk of intentional contamination.  It’s a software program called the Food Defense Plan Builder and it’s designed to be easy to use. This desktop tool can be downloaded free of charge at www.fda.gov/food/fooddefense/.

This exciting new tool guides users through a series of substantive questions about the user’s food facility and the food manufactured, processed, packed, or held there to help the user develop a facility specific food defense plan. The tool will guide owners and operators by prompting them to ask the right questions in food defense planning: What are we already doing to protect our facility? What aren’t we doing that we should or could be doing? What are the vulnerable points within our system and how do we provide added protections? And it even helps with developing a plan to manage, track and prioritize the action steps identified using the tool.

While the use of the Food Defense Plan Builder is voluntary, we strongly encourage food facilities to create food defense plans. In our complex, global marketplace, it’s no exaggeration to say that an incident at one company could affect the whole world.

So, what’s your plan?

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

Julia Guenther, is a Policy Analyst, Food Defense and Emergency Coordination Staff, at FDA’s Center for Food Safety and Applied Nutrition

 

Honoring an FDA Champion of Safe Treatments for Children

By: Margaret A. Hamburg, M.D.

It has been 11 years since Congress passed the Best Pharmaceuticals for Children Act mandating the creation of the Office of Pediatric Therapeutics (OPT) at FDA.  But it has been light years in terms of the progress we have made to ensure that children have access to innovative, safe and effective medical products.

Margaret Hamburg, M.D.Increasingly, parents can rest assured that the medications they give their children have been tested—in children—in scientifically necessary and ethical clinical trials. OPT’s Pediatric Advisory Committee has reviewed over 200 products for their safety when used by children. Today, nearly 500 drug and biologic products have been improved by including, in their labeling, information describing safety, effectiveness and, where appropriate, dosing relating to use of the product in children. 

We’ve come a long way. And as director of OPT since 2003, pediatrician Dianne Murphy, M.D., has led the charge.

It is because of her indefatigable work on behalf of children that the American Academy of Pediatrics (AAP) has bestowed on Dr. Murphy its Excellence in Public Service Award (EPSA) “representing the highest honor awarded…to a public servant for distinguished service to the nation’s children, adolescents and young adults.” In the letter informing Dr. Murphy of this honor, AAP says her work at FDA “has profoundly improved the lives of children in the U.S. and around the world through increased access to needed therapeutics.”

I couldn’t agree more.

For many years before Dr. Murphy began her tenure at FDA, the playing field badly needed leveling when it came to safety in children’s drugs. Very few drugs—even those meant solely for children’s use— were actually tested on children. For one thing, some drug companies, eager to get their new products out while they still held exclusivity (that is, the period of time during which generic drugs cannot be developed), were reluctant to take the time or go to the expense. Many people, too, felt it was unethical to use children as so-called “guinea pigs.”

Without the information gained from testing children in clinical trials, health care professionals and parents alike could only guess when trying to gauge the correct dosages for children.

This was an enormous problem. Children are vulnerable. Their organs are developing, and they are experiencing physical changes that affect how a drug is metabolized. As Dr. Murphy has often said, guessing at the dose just doesn’t work. Children must be studied if we are to give them safe and effective treatments.     

The sea change began ten years before her arrival at FDA, when AIDS was entering the public consciousness. Dr. Murphy has told me that at the time, she was treating children in her practice who were dying of AIDS because there were no drugs available specifically to address their unique needs.

Based on that hard lesson, a major priority when she came to FDA was to ensure that drugs for children first be tested in children in clinical trials. Dr. Murphy has worked with FDA scientists and reviewers to ensure that pediatric studies are rigorously designed and conducted in accord with current scientific understanding of the characteristics that make children unique. And she has championed FDA’s involvement in the international arena, where FDA has emerged as a leader in regulatory thinking.

In achieving this honor, Dr. Murphy is in very good company. She shares it with such distinguished former honorees as First Lady Michelle Obama, the late Sen. Edward M. Kennedy, Rep. Henry Waxman, former FDA Commissioner David A. Kessler, and National Institutes of Health Director Francis S. Collins.

At FDA, we offer our congratulations, and our thanks.    

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

Let’s Keep Talking—and Listening—About Food Safety

By: Michael R. Taylor, J.D.

Everyone has a stake in the rules that FDA is proposing to strengthen the food safety net in this country.

Michael R. Taylor, J.D.We have reached out far and wide to engage in conversations about the first two proposed rules mandated by the FDA Food Safety Modernization Act. The produce safety rule would set standards for production and harvesting of fruits and vegetables. The preventive controls rule for human food would set safety requirements for food facilities.

Since these rules were proposed in January 2013 and published in the Federal Register for public comment, my colleagues and I have been engaged in an ongoing dialogue with a range of consumers, farmers, manufacturers and others who are affected by the proposals.  When we say that we want the public to comment, we mean it. We need that feedback to ensure that what we plan to do is what we should do. In fact, we have extended the comment periods for both proposed rules for another 120 days.

I recently met with tree fruit farmers from Washington State who wanted to talk about how they would be affected by proposed standards for irrigation water. I’ve attended other small-group meetings with a cross-section of people and organizations concerned about what these rules will mean to them. And our FSMA implementation team has been providing overviews of the proposed rules and answering stakeholder questions every day since the rules were first published.

On a larger scale, there have been three public meetings, in Washington, D.C., Chicago and Portland,OR. At each meeting, the crowd was large, diverse, and intensely interested, asking detailed questions about the basis for certain provisions and how they would work in specific cases. We learned a lot that will help us address these questions and be sure that the final rules are both effective for food safety and workable across the great diversity of the food industry. 

We also learned that a broad cross-section of our industry and consumer stakeholders are eager to push forward and work with us to successfully complete this crucial rule-writing step in FSMA implementation.   

None more so than 15-year-old Rylee Gustafson, who nearly died from eating contaminated spinach six years ago. She spoke in Portland:

“When people ask me why I am passionate about food safety, the answer is simple:  I don’t want anyone to have to go through what I did—or worse, die because of something they ate. I have been able to take my experience and make a positive impact by sharing my story. But my job as a food safety advocate is far from over. Being here today—to support the FDA in the release of the proposed produce safety rule and to encourage the agency to finalize it quickly with the hope that fewer people, young and old, are forced to suffer because of foodborne illness—is just the next chapter in my story.”

Rylee reminds us why we do this work and why we are so committed to helping write that next chapter.

There are three more FSMA-mandated proposals on the horizon that form the basic framework for a modern, prevention-based food safety system. Two are designed to keep imported foods safe from contamination and the third is to protect animal food. Then, as now, we will want your opinion of what we’re planning. We want to engage you as partners in making these reforms a reality.

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