Category Archives: Globalization

The road ahead for ensuring access to quality drugs for all Americans… new laws under “FDASIA” will help pave the way

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By: Howard Sklamberg 

In January, I became director of FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance, giving me the responsibility – and great privilege — of playing a lead role in FDA’s work to help protect the American public from unsafe and ineffective drugs. It’s a big job, filled with many challenges. 

Fortunately, after three years of service with FDA, most recently as the agency’s deputy associate commissioner for regulatory affairs (our field operation), and 12 years before that as a prosecutor with the Justice Department, I feel prepared to help the agency meet these challenges head on. 

I’d like to take an opportunity to share my priorities, as well as my views and perspectives on the goals and challenges ahead for FDA, as we continue to work to ensure access to quality drugs in the United States. 

Tragically, last October’s outbreak of fungal meningitis from contaminated methylprednisolone injections that killed over 50 Americans and sickened hundreds more directed FDA’s attention to the immediate public health priority of evaluating the quality of sterile compounded drugs and preventing further incidents. Our efforts have included proposing a new legislative framework for federal oversight, inspecting high-risk compounding facilities that produce sterile drugs, and working more closely with our state partners. 

As important as our efforts are in the compounding arena, our compliance challenges extend to many other critical areas, many of which are related to the new and growing global marketplace for pharmaceutical products. 

Today, nearly 40 percent of the drugs Americans take are imported and nearly 80 percent of the active ingredients come from overseas sources. A growing number of clinical trials that test the safety and effectiveness of potential new drugs are also moving overseas, making FDA oversight more challenging. Counterfeit drugs are proliferating around the world and sometimes even entering the U.S.supply chain. The ever burgeoning worldwide use of the Internet continues to spawn avenues for illegal online sales of medicines of unknown safety and quality. Also, poor manufacturing practices that lead to facility shut-downs often contribute to shortages of important drugs. We must ensure that wherever drugs are made, wherever their ingredients are from, or wherever and however they are tested and sold, that they meet FDA’s strict standards of quality and that they remain in adequate supply. 

Despite these challenges, there’s good news. The Food and Drug Administration Innovation and Safety Act of 2012 (FDASIA) gave FDA powerful new tools to enhance our compliance and enforcement activities including stronger authorities and funding to support the inspection of foreign manufacturing facilities. For example, FDASIA facilitates our ability to partner with and work more effectively with foreign regulatory agencies. FDASIA also gave FDA more authorities to control the drug supply chain. 

However, laws on the books do not automatically translate into effective change without effective implementation and enforcement of these laws. So, in addition to continuing our critical work with Congress on appropriate and effective oversight of compounding that exceeds the bounds of traditional pharmacy compounding, my other key priority is to work to implement FDASIA’s provisions, keeping CDER focused globally and armed with the best set of tools possible to do the job. Although we have much more work to do, a vision of enhanced capabilities of ensuring quality drug products for the American public is well in sight. 

I have the distinct privilege and responsibility of being part of a fantastic team of dedicated FDA staff that’s really making a difference, and I look forward to continuing to serve the American public in working to ensure access to quality drugs. 

Howard Sklamberg is Director of FDA’s Center for Drug Evaluation and Research’s Office of Compliance

Importing Drugs to Address Shortages

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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

Food Defense – What’s Your Plan?

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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

 

FDA’s Collaboration with Chinese Partners Gets Stronger Each Year

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By: Mary Lou Valdez

“What’s in a name?” Shakespeare famously asked. “A rose,” his Juliet reasoned, “by any other name would smell as sweet.” And often, we know, that’s true.  But other times, a change in name can signify some larger, more substantive shift.

The latter was the case in mid-April when we sat down in Washington to meet with one of China’s key regulatory agencies, the China Food and Drug Administration (CFDA). Just weeks before arriving in Washington, during the 12th People’s Congress in Beijing, CFDA had gained new authorities from the Chinese government, and had been given a new name. CFDA became the new moniker for what was formerly known as the State Food and Drug Administration (SFDA). At the same time, it gained enhanced authorities. Most notably, CFDA was given overall authority over China’s domestic system for food safety, absorbing roles previously overseen three other Chinese government agencies. CFDA was also elevated to become a ministry, reporting directly to China’s State Council—the equivalent in U.S. terms of becoming a cabinet-level agency.

But even before this name change and “promotion” within the Chinese government, CFDA had evolved significantly in the years since we began high-level talks with them in 2007. Over the years, these bilateral meetings— which are required annually under the terms of the agreement the U.S. Department of Health and Human Services signed with then-SFDA in 2007—have served as a barometer of our evolving relationship with Chinese regulatory authorities.

Names and titles in the picture (from left to right): Xinyu WENG, Division Director, Dept. of Drug Safety & Inspection, CFDA; Enxue CUI, Council, Bureau of Investigation & Enforcement, CFDA; Zhenjia BIAN, Commissioner's Special Representative, CFDA; Margaret A. Hamburg, Commissioner, USFDA; Jianhua DING, Supervisor-General, Dept. of International Cooperation, CFDA; Lanming WANG, Director-General, Dept. of Medical Device Supervision, CFDA; Xiangyu WANG, Deputy Division Director, Dept. of International Cooperation, CFDA

In 2007 and 2008— years that by all accounts were difficult ones for China with respect to the safety of its exports— exchanges were often challenging, fraught with tension and growing pains. These early efforts represented the first-ever set of talks between senior officials at FDA and then-SFDA, and took place in the context of highly-publicized product-safety issues that dominated those years. Challenges have certainly not gone away in the intervening years, but our April 2013 talks made clear that our relationship with CFDA has matured significantly since those early efforts. Where 2007 represented, in many ways, an introduction, and 2008 marked the first-ever establishment of a bilateral work plan, today, most officials involved in these talks come to the table well-known by their colleagues on the other side of the table. And the slate of topics for our April meeting made clear the deep collaboration between FDA and CFDA across more than a dozen topic areas.

While much of the strengthening of our relationship with CFDA has come through day-to-day collaboration between FDA’s China Office and CFDA officials in Beijing, there are significant ties in multiple areas across our agencies:

  • A working group on economically-motivated adulteration (the fraudulent substitution of a substance in a product to increase value or reduce production costs for the purposes of economic gain) meets on a regular basis by video, linking Washington-based experts with CFDA’s key decision-makers.
  • Experts from FDA’s Center for Devices and Radiological Health now meet regularly with their counterparts from CFDA under the auspices of the International Medical Devices Regulatory Forum.
  • FDA and CFDA collaborate closely under the auspices of the World Health Organization’s Working Group for Member States on Substandard, Spurious, Falsely-Labeled, Falsified and Counterfeit Medicines. FDA and CFDA inspectors observe one another’s inspections, and in May 2013, FDA and CFDA will co-host workshops to enhance our collaboration in the fight against internet-based, illegal distribution of adulterated drugs.

The list goes on. Change— of organizational names, of personnel— will continue. Based on our recent talks with CFDA, however, it is clear that one constant will remain: the mature relationship our agencies have built enabling us to better address challenges to consumer and patient safety in years to come.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

 

FDA Counterfeit Detector to Aid Battle Against Malaria

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By: Deborah M. Autor, Esq. and Melinda K. Plaisier

Deborah M. Autor

Somewhere right now, malaria patients facing a life-threatening illness are being treated with counterfeit or substandard anti-malarial drugs, including falsified products, that threaten their recovery and can contribute to drug resistance. We are proud to announce the Food and Drug Administration’s launch of a partnership that will use a clever, innovative tool invented by FDA scientists to quickly and cheaply test suspect counterfeit or substandard anti-malarial drugs, including falsified products. The partnership will test the effectiveness of this hand-held, battery-operated tool, called Counterfeit Detection Device, Version 3, or, simply, CD-3. It will be deployed first in Ghana and then, after data is collected, in a second testing region.

This effort, which we hope will expand worldwide, is aimed at catching products that both deprive people of critical, life-saving help and add to disease burden because substandard doses can lead to drug resistant strains of the malarial parasite.

Melinda K. Plaisier is FDA’s Acting Associate Commissioner for Regulatory Affairs

Melinda K. Plaisier

Malaria kills more than a 660,000 people each year, mostly children. It is most prevalent in Africa and Southeast Asia. In Southeast Asia and sub-Saharan Africa, more than a third of anti-malaria drugs are counterfeit or substandard, and a recent review indicates that number might be as high as two-thirds.

CD-3 is the brainchild of FDA scientists Nicola Ranieri and Mark Witkowski of FDA’s Forensic Chemistry Center (FCC), who recognized that since substances have unique responses to light, they might be able to develop a portable tool that could identify counterfeits on the spot, even in remote locations. As the initial tool has undergone a number of revisions, capabilities have been added, applications have been developed, and CD-3 has become a more powerful tool. From prototypes, scientists at FCC built a number of CD-3s, which are currently being used in the U.S. at ports and international mail centers, and during criminal investigations at the FCC.

To gear up for a global deployment strategy, FDA has separately signed a letter of intent with Corning, Inc., to optimize the tool, using information gathered from the studies in Ghana and the second testing region. FDA is hopeful that the improved tool will eventually be manufactured for use around the world.

The CD-3 tool contains a library of information about authentic drugs and the packaging they come in. It allows the user to compare authentic images of a product with the suspect product, instantaneously showing clear differences between suspect and authentic products that would not have been clear to the naked eye.

The Unites States Pharmacopeia, with funding through the U.S. Agency for International Development and the President’s Malaria Initiative, currently conducts drug surveillance programs at the test sites where CD-3 will be tested. FDA is providing ten CD-3s in the first test, and technical support will be provided by the Centers for Disease Control and Prevention and the National Institutes of Health. The non-profit Skoll Global Threats Fund is providing additional funding for the initial testing in Ghana.

We are thrilled about these developments and proud of this important, multi-sector collaboration and our highly dedicated staff who are making it possible. It is a credit to them, to our partners, and to all of FDA, that they are able to bring this innovative solution to such a significant global public health problem.

To learn more watch the CD-3 video below and read the Consumer Update: FDA Invention Fights Counterfeit Malaria Drugs

Deborah M. Autor, Esq., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Melinda K. Plaisier is FDA’s Acting Associate Commissioner for Regulatory Affairs

FDA’s Criminal Enforcement Priorities Protecting Public Health

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By: John Roth

Although perhaps not widely known, FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health.  FDA’s team of top-flight federal agents – who have the same type of arrest authority as other federal law enforcement agents – gives the FDA unique fact-finding tools and provides for strong, industry-wide deterrence. Their work is different from, but enhances, the regulatory work typically conducted by inspectors and investigators that makes up the bulk of FDA’s field operations.

OCI focuses its efforts on threats to the public health in four areas: we investigate criminals who can’t be reached by the rest of FDA, particularly in the area of counterfeit and unapproved medical products; we move against public health problems when our ordinary regulatory tools aren’t the best option; we seek criminal penalties against conduct in which the harm to the public is so grievous that a criminal response is appropriate; and we investigate lying to the FDA and other behavior that deprives the FDA of its ability to regulate. We have a variety of tools at our disposal to accomplish our mission, including felony charges under the Federal Food, Drug, and Cosmetic Act, misdemeanor prosecutions of responsible corporate officers, and prosecutions for fraud, money laundering and obstruction of justice.

It’s a big job.  FDA regulation affects more than 20 cents of every consumer dollar spent on products in the U.S. And the fact is, some conduct by individuals and entities is beyond the reach of FDA’s typical administrative and civil enforcement tools. This conduct includes rogue internet pharmacies, purveyors in grey and black market unapproved medicines, and counterfeiters, both in the United States and overseas. Individuals intent on defrauding an unsuspecting public are often part of a larger organized criminal enterprise and don’t respond to the normal FDA regulatory process. They are engaged in a crime, and as a result the FDA treats it as a crime, and that’s where OCI steps in. 

The case of Shengyang Zhou is a good example. In January 2010, the FDA became aware of counterfeit versions of the popular weight loss drug Alli being distributed in the United States, and warned consumers about its dangers. The counterfeit product had entered the legitimate supply chain lacking the active ingredient contained in the genuine Alli and, especially alarming, contained undeclared amounts of the drug sibutramine, which is no longer sold in the United States because of concerns over its association with increased heart attacks and strokes. OCI agents had initiated a criminal investigation after intercepting unapproved dietary supplements laced with sibutramine and phenolphthalein that had been shipped from China to an individual in Colorado. This seizure ultimately led to OCI agents developing an undercover operation against a Chinese counterfeiter, Shengyang “Tom” Zhou. Posing as buyers, OCI Special Agents met with Zhou in Bangkok and negotiated a sale of counterfeit drugs to be shipped to the United States. During the undercover operation, Zhou bragged that he had a factory in southwest China that could make thousands of boxes of weight-loss products per day. Zhou was ultimately arrested, pled guilty, and was sentenced to 87 months’ imprisonment.  Evidence presented at Zhou’s sentencing included a physician who had unsuspectingly taken the counterfeit Alli and suffered a stroke.

Admittedly, not all our work is this interesting and dramatic. But this is a good example of the truly remarkable skills – from technological and scientific, to the intangible personal skills of working undercover overseas – that our agents bring to the task. In a future blog, I’ll explain our work when ordinary regulation is insufficient and when we move against people who lie to the FDA, which prevents the Agency from doing its regulatory job. Some may not be as colorful as the example above – but all will show the key role of OCI in furthering the FDA mission in protecting the public health. 

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

 

 

FDA Collaborates with Mexico to Improve Food-Safety Testing

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By: Carl Sciacchitano

En Español

FDA and public health officials in Mexico are working together to increase the capacity and capabilities of laboratories used to test the safety of foods.

In January, 2012, FDA scientists met with Mexico’s National Service of Health, Food Safety and Agro-Alimentary Quality (SENASICA) officials to better understand laboratory operations, practices, methods and quality assurance. Our scientists were also able to visit the SENASICA laboratories and discuss opportunities that would enhance laboratory collaboration and capacity building efforts. 

FDA’s 2011 special report, “Pathway to Global Product Safety and Quality,” states that the agency will partner with nations around the world to enhance global product safety and quality. Additionally, FDA recently released its International Food Safety Capacity-Building Plan that addresses both the acceptance of laboratory methods across the international community and the exchange of information on current and new laboratory methods.

In Mexico, the key objectives of this FDA/SENASICA collaboration include improving communications and laboratory capacity, consulting with SENASICA on the development, validation and implementation of testing methods, and participation in proficiency programs.

To reach our joint goals, the FDA/SENASICA Laboratory Capacity Collaboration Program (LCCP) has been established to enhance our collective ability to strengthen laboratory capacity and capabilities in effective and sustainable ways. 

LCCP participation includes our experts from FDA’s Office of International Programs in Mexico City, Office of Regulatory Affairs (ORA), and Center for Food Safety and Applied Nutrition (CFSAN). Working with representatives from the SENASICA National Laboratories, these experts formed a cohesive unit and prioritized key leveraging opportunities to enhance public health through the LCCP. Highlights of LCCP’s work include:

  • In March 2012, FDA’s Northeast Regional Laboratory (NRL) hosted a Mexican delegation of laboratory experts representing SENASICA’s three main laboratories. NRL provided an overview of FDA’s food testing laboratory, highlighting microbiological and chemical (food and drug) disciplines. NRL scientists shared methods currently used by FDA for the analysis of microbiological and chemical contaminants in foods under FDA’s jurisdiction. A portion of the visit was devoted to discussion and observation of the equipment, laboratory environment and methods used to perform these analyses. Communication channels were created to enhance collaboration.   
  • This effort between FDA and SENASICA scientists was very timely as SENASICA is pursuing efforts to strengthen its laboratory infrastructure for microbiological testing.  The information shared by our FDA scientists directly impacted SENASICA’s early thinking and understanding, resulting in the development of a state-of-the art microbiological testing laboratory. This laboratory will monitor the safety conditions of food during production, processing and packaging through the microbiological analysis of water, fresh produce (fruits and vegetables) and environmental samples of risk areas. In December 2012, we participated in the laboratory opening ceremony in Mexico City. The opening of this laboratory highlights the success of the LCCP efforts.  
  • Mexico’s Sinaloa state lab and FDA provided a training course for SENASICA microbiologists in December 2012 on Pulse-Field-Gel-Electrophoresis (PFGE) and serological techniques. Both techniques are staple methods utilized for the identification and traceback of bacterial strains – critical information that often augments foodborne outbreak investigations. The course was held in SENASICA’s new pathogen detection laboratory.

In 2013, our governments’ goal is to build on the progress from 2012 to enhance public health protection. Sharing information on best laboratory practices and collaborative efforts in method development and validation studies headline some of our key objectives for 2013.

Carl Sciacchitano is a Senior Advisor for Scientific International Affairs in FDA’s Office of International Programs

FDA’s International Food Safety Capacity-Building Plan: Improving Food Safety Protections Around the World

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By Julie Moss, Ph.D., R.D., and Katherine Bond, Sc.D.

Our increasingly globalized world means that more and more of the food we eat is imported. Congress recognized this fact of modern life by passing the FDA Food Safety Modernization Act (FSMA), landmark legislation signed into law in 2011 that shifts the emphasis from responding to food safety incidents to preventing them.

Julie Moss

In that spirit, Congress saw the importance of improving the capacity for food safety protections. It directed FDA to develop a comprehensive plan to expand the technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries in countries that export foods to the United States.

FDA has met that challenge, recently releasing its International Food Safety Capacity-Building Plan, which provides a strategic framework intended to guide FDA’s capacity-building efforts over the next five years. FSMA marks the first time that Congress has charged FDA with comprehensively addressing the building of international food safety capacity, a development that has been very exciting for us.

While this mandate is new, we have successfully supported food safety capacity-building efforts and conducted training programs for many years. The agency has participated in global, multilateral food safety programs, including work with the World Health Organization, train-the-trainer programs (in areas such as good agriculture practices), various seminars and web postings, and collaborations with other U.S.government agencies, among other efforts. However, FSMA allows us to take this work to a whole new level.

For example, we are working with foreign governments to see if we can exchange more scientific and technical information, such as outbreak and inspection data. This will open up communication channels and promote collaboration with those governments. We are also working to support both the acceptance of laboratory methods across the international community as appropriate and the exchange of information on current and new laboratory methods. This helps ensure that the data obtained from different domestic and international laboratories is of good quality and can be easily compared.   

We have developed a plan that incorporates many of FSMA’s main principles, including comprehensive prevention, risk-based resource allocation, and partnering. The plan’s key goals are:

  • Goal 1: Ensure efficiency across the Foods and Veterinary Medicine Program
  • Goal 2: Increase effectiveness through evidence-based decision making
  • Goal 3: Support the exchange of information between FDA and other foreign government agencies or other entities
  • Goal 4: Enhance technical assistance and capacity-building in food safety

    Katherine Bond

Overall, the plan charts a direction for how we will prioritize our capacity-building efforts based on risk, how we will link capacity-building efforts to their impact on public health, and how we will work in partnership with counterpart authorities, industry and other organizations to achieve lasting food safety results. Through this plan, countries that export to the United States will have an opportunity to learn about our food safety capacity-building priorities and see the breadth of the efforts that we are pursuing.   

In developing this plan, we consulted with foreign governments, industry, non-governmental organizations, certain U.S.officials, academia and other stakeholders. A public meeting was held on June 19, 2012, and comments received were considered in development of the plan [Docket No. FDA-2012-N-0437].

Given the breadth of this work, it is essential that we collaborate with partners to get the work done. We realize we can’t do it alone. Partnerships are important in everything we do, and even more so with capacity building. We also recognize the importance of establishing strong relationships and mutual support among all stakeholders from farm to table. As we begin to implement this new plan, we look forward to sharing ideas and new information with our international counterparts and other interested stakeholders, leveraging resources that will help us improve global food safety.

Julie Moss, Ph.D., R.D., is Deputy Director, International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition

Katherine Bond, Sc.D., is Director, Office of Strategy, Partnerships and Analytics, in FDA’s Office of International Programs

 

Public Meeting on Food Safety Highlights First Two Proposed Rules

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By: Michael R. Taylor

Last week, we kicked off a series of public meetings—with about 400 people participating—to stimulate dialogue and gain input on FDA’s first two proposed rules to implement the FDA Food Safety Modernization Act. In her opening remarks, Dr. Hamburg noted how her appointment as FDA Commissioner by President Obama, coming on the heels of the illnesses and deaths attributed to contaminated peanut products, helped make food safety a high priority for her and the Administration.

Michael R. Taylor, J.D.It was fitting that we held our first meeting in a USDA auditorium in Washington, D.C., because we have worked closely with USDA and with other government partners at the state and local level, as well as with industry and consumer groups, to get the rules right.  That means holding a lot of meetings to explain the proposed rules, visiting farms and facilities, and opening dockets for comments from interested parties, to receive as much input from the public as possible before we finalize the rules.

The diversity of those who signed up to make public comments at the meeting shows how important food safety is to all of us, from victims of foodborne illness to farmers and food manufacturers. First up was 15-year-old Dana Dziadul, who was three years old when she became ill from Salmonella in cantaloupe. The compelling stories from Dana and other victims of foodborne illness, and their families, remind us all that first and foremost, we have a public health obligation to address the harsh reality that each year, 3,000 people die and more than 100,000 are hospitalized because of foodborne illness. Our first obligation is to do everything we can to reduce these numbers.

We also know that improving food safety helps avoid the disruptions in the marketplace that result from illness outbreaks and recalls of food and maintain consumer confidence in healthful foods, such as the produce that the proposed rules cover. This convergence of interests has made our current food safety initiatives a real community effort, with industry, consumers and government coming together around the common goal of modernizing our food safety system to better prevent problems. We all have a responsibility, and we all have a role, in making and keeping food safe.

The work ahead may sound simple—having the right standards in place that are based on the best information we have on how to prevent hazards, and making sure these standards are met. But we have much yet to accomplish. We have to make sure the standards are flexible enough to address the diversity of operations across the country—from small farms to large facilities, from Maine to California. We also need to be sure FDA is ready to operate under this new, prevention-oriented framework, which will require employee training and ensuring our resources are focused on the greatest risks. And we are committed to providing technical assistance so that industry, especially small operations, can meet the new requirements when they are finalized.

These two proposed rules we have announced are very important, but we have three additional rules coming to further form our food safety framework. To address the safety of imports, we will soon be proposing a rule that requires that importers based in the United States verify that their overseas supplies are following prevention-based standards that provide the same level of public health protection as those that are in place here. Also addressing imports is a proposed rule on the accreditation of the third party auditors that industry uses to help them determine if food safety standards are being met. The third proposed rule coming addresses preventive controls for animal food, including pet food.  Preventive controls are steps that firms must put in place to control hazards such as microbial contamination that could occur in a food facility.

We will be holding two more public meetings—one in Chicago and one in Portland, Oregon. You can find more information on our web site at fda.gov/fsma. Six meetings in various states across the country also are scheduled. Your comments are important to us, and I encourage you to submit comments at regulations.gov before the May 16th deadline. 

The road ahead is a long one, and it will take years, and sustained commitment, to have our framework fully in place. But, for America’s families and our vibrant food system, the hard work is absolutely worth it!

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

 

Rare Disorders Without Borders: An International Strategy

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By: Katherine Needleman, Ph.D.

The development of 200 new therapies for rare diseases and diagnostic tests for most rare diseases would alleviate untold suffering. So with great enthusiasm, FDA’s Office of Orphan Products Development (OOPD) has joined a global effort to make those goals a reality by 2020.

These are the goals of the International Rare Disease Research Consortium (IRDiRC),  launched by the European Commission and the U.S. National Institutes of Health in April 2011 to foster collaboration in rare disease research. FDA’s OOPD recently joined IRDiRC’s Executive Committee. When the consortium holds its first major conference in Dublin in April, top experts and researchers from around the world will share information and foster collaborations.

Collaboration is critical. Rare disease resources, including experts, are so limited that we cannot afford to waste a single moment by duplicating work or failing to share promising developments. Products for rare diseases are often called “orphan products” because they generally lack sponsors to develop them.

Some rare diseases affect only a few hundred people, and by FDA’s definition, each one affects no more than 200,000 people in the U.S. Yet taken together, about 7,000 rare diseases afflict about 30 million Americans and a similar number in Europe. In much of the world, they go undiagnosed. Often, they are debilitating or deadly. Many are genetic, so children are often victims.

Today, on Rare Disease Day 2013, the international rare disease community comes together with the theme “Rare Disorders Without Borders,” and FDA continues its commitment to close collaboration with international counterparts, such as the European Medicines Agency.  

FDA is the first regulatory agency to join the consortium’s Executive Committee. In addition, FDA is represented on the consortium’s Therapies Scientific Committee by Marc Walton, M.D., Ph.D., in FDA’s Center for Drug Evaluation and Research. We hope to bring regulatory scientific perspectives that help develop great research ideas into great products that meet regulatory approval standards for safety and effectiveness.

FDA has been working to change the orphan status of rare diseases since 1983, with the passage of the Orphan Drug Act. Since then, FDA has approved over 400 products for the treatment of rare diseases, compared to only 10 developed by industry in the decade before the act.

OOPD’s grant program uses its annual budget of approximately $14 million to fund top scored clinical trials of rare disease treatments. The grants program has been successful, as at least 49 OOPD grants supported clinical trials that contributed to agency approval of these products for rare diseases.

Still, for most rare diseases, there are no treatments, or definitive diagnostic tests.

Recent progress in human genomics and newly emerging sciences increase the prospect for treatments or even cures. A new generation of therapies even shows promise for changing the defective genes that result in some rare diseases. These are among the topics that will be addressed at the upcoming conference.

Our OOPD Director, Gayatri Rao, M.D., J.D., will present FDA’s perspective at the IRDiRC meeting while I will be working on the challenges ahead through the Executive Committee as FDA helps ensure that the energy and expertise brought to the conference is harnessed to bring results to patients.  

The need is great; the time is now.

Katherine Needleman, Ph.D., is director of the Orphan Products Grants Program of FDA’s Office of Orphan Products Development.