Category Archives: Other Topics

When Regulators are Ignored

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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

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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

Saluting Dr. Janet Woodcock: an FDA Advocate for Arthritis Sufferers

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By: Margaret A. Hamburg, M.D.

Physicians who work at FDA have typically trained in one or more medical specialties — areas of concentration which shape their interests and inform the regulatory work they do here to protect and promote the public health.

Margaret Hamburg, M.D.In my own case, I earned a degree in internal medicine and then focused on infectious diseases, eventually advocating for reforms to confront the dangers of modern bioterrorism, and looking for ways to counter the threat of naturally occurring infectious diseases, such as HIV, pandemic flu, and drug resistant TB.

So, too, it is with the inimitable Janet Woodcock, M.D.

Dr. Woodcock first joined FDA in 1986, and in her years at this agency has served in numerous capacities, including FDA deputy commissioner and chief medical officer. Today, she is director of the agency’s highly-respected Center for Drug Evaluation and Research.

At its recent annual Advocacy Summit, the Arthritis Foundation presented Dr. Woodcock with its Floyd B. Odlum Making a Difference Award, which honors an individual, organization, corporation, or government agency that has helped to make a difference in the lives of people and families with arthritis.

Striking one in every five adults, arthritis is the nation’s leading cause of disability. And it’s not just a disease of old age. Two-thirds of people with arthritis are under the age of 65, including 300,000 children.

Those numbers are not lost on Dr. Woodcock, who began her medical career as a rheumatology specialist, and ever since has been helping to shape and inform the advancement of arthritis treatments.

Dr. Woodcock has been a key figure in the revolution of rheumatoid arthritis therapies, from drugs that broadly address arthritis inflammation to today’s highly-effective, targeted, treatments. She is also helping to shape FDA’s regulatory framework for an abbreviated path to market for biosimilar drugs, those that are shown to be, among other things, highly similar to an already-approved biological product.

Once these drugs become available, they could increase choices for patients and reduce what those patients pay for certain arthritis therapies. Throughout her tenure, Dr. Woodcock has been an active liaison with the rheumatology community, crafting guidance on the development of arthritis medications, partnering on ways to measure a product’s safety and effectiveness, and studying products once they go to market.

In ensuring that safe drugs continue to be developed and become available to the many arthritis sufferers across the country, Dr. Woodcock has remained constant in her dedication to alleviating the pain and suffering of arthritis patients, and so many others. She has insisted upon scientific rigor in the work FDA does.

She has herself said, “I am continually challenged to make sure that FDA’s regulatory process remains the world’s gold standard for drug approval and safety.”

Those who know Dr. Woodcock would agree with me when I say she is a force to be reckoned with. We thank her for that, and along with the Arthritis Foundation, we salute her for all that she does to advance public health.  

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

A Key FDA Resource for Industry and the Public: Working with the FDA Office of the Ombudsman

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By: Andrew Moss and Laurie Lenkel

Like many Federal agencies, FDA has a robust ombudsman program that addresses concerns and complaints from regulated industry and the public. At FDA, most product evaluation centers house their own ombudsman staff that address center specific issues. The FDA Office of the Ombudsman, as part of the Office of the Commissioner, provides this function for the agency as a whole.   

Click Image to Download this brochure (PDF 1021 KB)

While some think of an ombudsman as a type of court of last resort or legal adviser, the FDA Office of the Ombudsman rather acts primarily as a counselor or informal mediator. An ombudsman may be called upon by interested parties to provide guidance and assistance at any stage in a dispute, complaint, or other problem that relates to the work of the agency—not only when a matter reaches an impasse. Addressing problems early can often aid in their resolution.

The FDA Office of the Ombudsman employs some basic guiding principles that allow it to serve in this mediating role: 

  • Neutrality—we engage in matters free from bias and independently from the agency components involved; 
  • Transparency—we strive to be as clear and open as possible about the steps we are taking to provide assistance and about what we can and cannot do to help; 
  • Confidentiality— we maintain the confidentiality of all information provided consistent with applicable laws and regulations.

The FDA Office of the Ombudsman handles inquiries about the resolution of consumer complaints as well as inquiries from regulated industry regarding, among other things, agency action or delays in action, compliance activities, import issues, and actions of FDA field offices. We play an important role in assisting small businesses. Although small businesses are generally subject to the same regulations as any other entity, we can help to draw attention to the special needs and concerns of these companies. If nothing else, we can help small businesses to understand messages from the agency and to better communicate with FDA offices and staff, thereby helping companies to satisfy FDA requirements, which are designed to protect consumers and patients.

The tools we use to assist individuals and companies vary from situation to situation.  Sometimes we help them to better understand actions taken by FDA. At other times we can be helpful in calling attention to and moving forward action that has been delayed.  In many instances, we are able to facilitate a productive meeting between key FDA officials and the interested party to discuss and help move toward resolution of issues of concern. 

A new role for the FDA Office of the Ombudsman is in shepherding the consideration of scientific disputes raised by FDA employees that are not resolved elsewhere and rise to the level of the Commissioner, the head of the FDA. While there are often multiple legitimate ways to view different findings and to make regulatory or policy decisions, FDA is committed to the integrity of the underlying science and a science-based approach to its decision making, and places great value on ensuring that divergent scientific opinions are fully and fairly heard. Any FDA scientist can first raise a scientific dispute or disagreement within the center where they work through well defined processes, with the final arbiter being the Director of that FDA center.  However, if they are ultimately not satisfied that their views have been fully heard and considered by the Center, they can bring the matter to the Office of the Commissioner via the FDA Office of the Ombudsman for review of the process.    

Whatever the issue, question, or problem, the FDA Office of the Ombudsman stands ready to provide guidance and assistance. We are here to help. And if we can’t directly assist you in a given matter, we will identify the FDA component that can. You can contact us anytime at ombuds@oc.fda.gov, or visit us on the web. 

Laurie Lenkel is Ombudsman and Andrew Moss is Deputy Ombudsman in FDA’s Office of the Commissioner

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.

Advancing Science and Building a Healthier Society

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By: Theresa Castillo

Knowledge and education are critical, but “passion and perseverance” are also needed to eliminate health disparities, Assistant Health and Human Services Secretary Howard Koh, M.D., told a group gathered to pursue the goal of better health for all.

Dr. Koh’s call for even greater commitment was issued to more than 4,500 people who attended the Summit on the Science of Eliminating Health Disparities at the Gaylord National Resort and Convention just outside of the nation’s capital in December 2012. Since then, individuals and groups around the nation have returned to their jobs with new information gained from some of the more than 100 workshops that explored emerging sciences, policies and practices that can help eliminate health disparities that disproportionately affect minority groups.

Here at FDA, we are now in the midst of collaborating with the National Institutes of Health to publish recommendations and best practices that were highlighted at the summit and worthy of adoption on a broader scale. Articles published in peer reviewed journals also will be available at FDA’s Office of Minority Health Web site later this year.

The summit was led by the National Institute on Minority Health and Health Disparities and co-sponsored by FDA’s Office of Minority Health and the U.S. Department of Health and Human Services. Leaders in government, academia, business, medicine, science and public policy joined with advocates and others in the community to learn, share and build new alliances.

The ultimate goal: to share creative and innovative solutions that can be adopted widely to improve health in theU.S.and around the world.

The work on health disparities arises from a critical need. For example, African American men are 2.4 times more likely to die from prostate cancer than non-Hispanic white men, 10 times more likely to die of AIDS, and 60% more likely to die of stroke. Native American women are almost twice as likely to die of diabetes than non-Hispanic white women. And while Asian and Pacific Islanders are less than 5 percent of the population, they account for more than 50% of Americans living with chronic Hepatitis B and associated liver cancer.

The numbers reflect a complex web of causes, including unequal access to health care, environmental issues, genetic differences and lifestyle, to name a few. These variables and more were addressed at the summit.

The breadth of the effort is exemplified by listing even a few of the more than 100 workshop and roundtable titles: “Approaches for Identifying and Addressing Environment Health Disparities,” “Public Policies and Strategies to Address Obesity Prevention,” and “Reducing Health Disparities through Innovation.”

The summit brought together some of the nation’s foremost experts. Speakers included former U.S. Health and Human Services Secretary Louis Sullivan, M.D., NIH director Francis S. Collins, M.D., Ph.D.,  Mary Woolley, head of Research!America,  Kira Fortune, Ph.D. of the Pan American Health Organization, and David Fukuzawa of the Kresge Foundation.

The energy, commitment and knowledge gathered in one place left me inspired and convinced that together, we are on a path that will lead to improving health for all.

Theresa Castillo is a public health advisor in FDA’s Office of Minority Health

Celebrating African-American Contributions to Public Health

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By: Jonca Bull, M.D.

As a medical doctor and director of FDA’s Office of Minority Health, I am highly conscious of health disparities in the United States. Certain racial and ethnic populations respond differently to some medical products. FDA ensures that these differences are considered in its review of marketing applications for medical products.

But as an American, I am also highly aware how much all of us in this country have in common, a simple truth that emerges with particular clarity during this African American History Month, when we commemorate the 150th anniversary of President Lincoln’s Emancipation Proclamation and the 50th anniversary of the March on Washington.

Jonca Bull, M.D., is Director of FDA’s Office of Minority HealthBoth events have had a profound effect not only on African Americans, but on our entire nation. The Emancipation Proclamation was critical to President Lincoln’s efforts to end the Civil War and advance freedom. The March on Washington brought us Dr. Martin Luther King’s unforgettable call to America to live up to his “dream.” His vision of equality and racial harmony has been a steadfast guide for all Americans as we strive toward “e pluribus unum”— “Out of Many, One”, the ideal enshrined in the Seal of the United States.

This common bond unites us in many other ways.

As an ophthalmologist and a physician, I have a great admiration for the many distinguished African Americans who advanced medical science.

For example, Dr. Charles Drew discovered a method for the preservation of blood that was used extensively during World War II by the British military to save the lives of wounded soldiers. After the war, Drew was appointed the first director of the American Red Cross Blood Bank.

He was only one of many outstanding African-American scientists.

This honor roll includes Percy Julian, an Alabama native who earned a Ph.D. from the University of Vienna, and in 1935 synthesized physostigmine, a drug for the treatment of glaucoma, and cortisone for the treatment of rheumatoid arthritis.

It includes Daniel Hale Williams, the first surgeon to successfully perform open-heart surgery, Dewey Sanderson, the inventor of the urinalysis machine, Otis Boykin, who designed a control unit for the heart pacemaker, and Michael Croslin, who computerized blood pressure devices.

As a civil servant, I celebrate the history of African Americans by remembering their leadership in public health. The first to earn this distinction was Patricia Harris, a Howard University professor, who in 1979 became the Secretary of Health, Education and Welfare. Ten years later, the department was entrusted to the leadership of Dr. Louis Sullivan, the founder of the Morehouse School of Medicine. And in 1993, Dr. Joycelyn Elders, a pediatrician and public health administrator, became the first African-American to be named Surgeon General.

And as an FDA employee, I am proud to be working with many outstanding administrators and scientists of African-American ancestry who every day contribute to the public health and help advance FDA’s mission.

I have mentioned just a few of the distinguished narratives in our history that have been authored by remarkable African Americans—intellectuals, professionals, soldiers and artists of outstanding achievement.

I celebrate these women and men as fellow Americans whose extraordinary spirit, talent and efforts advance better health for all. I celebrate them as an inseparable part of my own proud heritage as an African American citizen.

Jonca Bull, M.D., is Director of FDA’s Office of Minority Health

Celebrating American Heart Month—Making Heart Healthy Choices in 2013

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By: Janelle Derbis, PharmD

Each year, nearly half of all Americans make New Year’s resolutions. They often include losing weight, starting an exercise program, quitting smoking, and making healthier food choices—all of which contribute to a heart-healthy lifestyle. February is American Heart Month, and the timing couldn’t be better to make these lifestyle changes, especially since heart disease is the leading cause of death in the U.S.

FDA joins in the commemoration of American Heart Month by highlighting agency initiatives to help Americans reduce their risk of heart disease.

Achieve a healthy weight. Obesity contributes to a number of health conditions, including high blood pressure and high cholesterol. To help obese and overweight Americans who have been unsuccessful in getting their weight under control with diet and exercise alone, FDA approved two long-term weight management medications in 2012—Belviq and Qsymia. These are the first medications the agency has approved for the treatment of chronic weight management in 13 years.

Quit smoking. Smoking and tobacco use contribute to many health hazards, including heart disease. Nearly half of adult Americans are at risk for heart disease and stroke, and over 20% are at risk due to cigarette smoking. To address the huge public health problem of tobacco use, FDA is building a national tobacco product regulation program to reduce the impact of tobacco use on the nation’s health. Using powerful new regulatory tools provided by the law, FDA’s work supports the objective of the Department of Health and Human Services to end the epidemic of tobacco-related death and disease in America. In November 2012, HHS announced the availability of a new comprehensive tobacco website, BeTobaccoFree.gov, a providing one-stop access to the best and most up-to-date tobacco-related information from across its agencies. This consolidated resource includes general information on tobacco, federal and state laws and policies, health statistics, and evidence-based methods on how to quit.

Eat right. Consumers can eat for a healthy heart and choose foods that are lower in salt, cholesterol, and trans-fat by reading the Nutrition Facts label on food and beverage packages.  In January 2013, the agency announced it is planning to update the Nutrition Facts label based on the latest science-based nutrition recommendations. The updates are still being formulated, and public input will be sought when they are proposed.

Lower cholesterol levels.  Making lifestyle modifications can help reduce cholesterol levels. However, hereditary issues can make some people more likely to have high cholesterol levels regardless of diet and exercise. The good news is there are treatment options for people who are unable to lower their cholesterol levels. There are several FDA-approved cholesterol lowering medications on the U.S. market.

In December 2012, FDA approved Juxtapid for a rare cholesterol disorder called homozygous familial hypercholesterolemia (HoFH), an inherited condition that makes the body unable to remove the “bad” cholesterol (LDL cholesterol) from the blood, which  can lead to heart attacks and death before age 30. The approval of Juxtapid is an example of how FDA provides the scientific and regulatory advice needed to bring new treatment options to market.

Control high blood pressure.  Adopting a healthy lifestyle can help prevent high blood pressure. If lifestyle modifications are not enough to lower your blood pressure so that it is within the normal limit (less than 120 over 80), medications are often prescribed. There are many FDA-approved medications to treat high blood pressure so talk with your health care provider to determine which is best for you.

In April 2012, FDA approved the first generic versions of Avapro (Irbesartan) and Avalide (Irbesartan and Hydrochlorothiazide) for the treatment of high blood pressure.  Generic drugs such as these provide safe and effective alternatives to brand-name drugs. 

Exercise. And lastly, physical activity is an essential component of a healthy lifestyle and when done in combination with healthy eating can help prevent heart disease. In 2013, make a commitment to exercising on a routine basis and keep your heart strong!

To receive up-to-date information on heart-related drug and device approvals, safety announcements, and notices of upcoming meetings, subscribe to FDA’s CardioBeat or visit FDA’s cardiovascular webpage.

Janelle Derbis, PharmD, co-manages the Cardiovascular and Endocrine Liaison Program (CELP), at FDA’s Office of Special Health Issues.

FDA’s Special Role: Ensuring Food Safety at the Inauguration

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By: Margaret A. Hamburg, M.D.

With the presidential inauguration just days away, it’s an exciting time to be in Washington, D.C. The police are setting up parade routes and security. Hotels and restaurants are bracing for crowds.

Margaret Hamburg, M.D.And the FDA is playing an important part as well. For certain events of national significance, such as U.S.-based Olympic games, national political conventions and U.S.-hosted summits of world leaders, we are called upon to marshal our expertise. This week, at the request of the U.S. Secret Service and D.C. Department of Health, we’ve assembled a team of 35 FDA staff from across the U.S. including 18 experts in retail foods and field inspection. Their mission? To work closely with the D.C. Department of Health, local county health departments in Maryland and Virginia, and the FDA Baltimore District Office to make sure that the food served at the inaugural ceremony and parade, balls and galas is safe to eat.

When you think about it, it’s not such an unusual role for FDA. After all, the agency works hand-in-hand each day with state and local public health agencies throughout the U.S. to ensure food safety.

And that’s what we’ll be doing this week. Our team of regional food experts will work with local health departments to protect food from contamination. We’ll review menus and observe food preparation, storage and service. We’ll train kitchen staff about risk factors, such as cleanliness, food temperatures and refrigeration. And information on food sources and supply chains at venues and vendors will be questioned so that if any foodborne illness is reported, we’ll have data to trace it back to the source.  

2009 inaugural salads

Data from the 2009 inauguration tells us that our inspections covered more than 100,000 meals. We expect similar coverage this time around.

It’s a privilege and an honor, but it’s also an enormous responsibility. Fortunately, we come prepared. We tackle this important challenge armed with years of valuable knowledge and experience in careful, data-based, cutting-edge science. We protect Americans from foodborne illness based on lessons learned over a long period of time. 

In ancient Rome, the emperors had special food tasters to make sure their feasts were safe and poison-free. Washington, D.C., isn’t ancient Rome, of course, and the “poisons” we are looking out for may be dangerous microbes.

But just as the Secret Service is responsible for overall security at the inaugural events, FDA is responsible for managing food safety and security in the retail food venues. We’ll work with the chefs and food services and facilities staff in D.C. to ensure that food safety standards are met. As the FDA Food Safety Modernization Act makes clear, our focus will be on preventing food safety problems before they happen.

The standards that FDA and our local health departments will be enforcing in the nation’s capital are the same as those we have in place every day for you and your families. Whether the lucky guests are at an inaugural ball or eating at a stand along the parade route, they can rest assured – as can you - that the regulations are the same for both, and that FDA is doing its part to help ensure that the food we all eat will be safe.

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

A New Law Advances Public Health: New Web Page Tracks Progress

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By: Malcolm Bertoni and Leslie Kux

After Congress passes a law that affects how FDA carries out its public health mission, we must begin the task of implementing the law — that is, putting the law into effect and enforcing it.

For a major piece of legislation like the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July, this is a complex undertaking.  

Malcolm Bertoni

FDASIA is a 140-page law divided into 11 separate sections, officially known as “titles,” which address different aspects of drug and device law. FDASIA reauthorizes and makes some changes to user fee programs that provide FDA with the resources we need to maintain a predictable and efficient review process for human drugs, biological products (such as vaccines), and medical devices.  

FDASIA also creates two new user fee programs:  one for generic drugs and another for biosimilar biologics. These new programs will allow FDA to enhance its efforts to ensure that American consumers have more timely access to safe, high quality, affordable medicines. The law also gives the agency new authority to protect the safety of the drug supply chain, which is so important when these products arrive from all corners of the world; to combat drug shortages; and to improve products used to treat children. The law includes many other provisions, including those involving drug innovation and device regulation.

The requirements of the individual provisions vary; some direct FDA to write new regulations or guidance documents that will help industry meet the law’s requirements, while some call for the agency to issue reports or develop strategic plans. Some provisions set specific timetables for action, others don’t.

Leslie Kux

The successful implementation of FDASIA is one of our top priorities. To ensure its success, FDA set up a steering committee shortly after the law was passed to oversee the task of integrating the requirements of FDASIA into the agency’s ongoing workload. One of the committee’s projects has been to create a table that tracks what FDA must do to comply with the statute.

Today we are making available a website that will allow you to follow the agency’s progress in accomplishing the actions required by the new law. The website includes a table that lists information about FDASIA tasks such as the citation to the section of the law, a description of the task, the statutory due date, and the name of a primary contact person. The table will also include links to pertinent documents as they are completed and published.

Initially, the table will include only those requirements with a due date set by Congress. In 2013, other requirements that were not given a specific due date will be added, along with FDA’s target completion date.

FDASIA is an important law with significant provisions affecting industry, patients, consumers and health care providers. We will be updating the website on a regular basis as part of our commitment to transparency about our FDASIA implementation.

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

Leslie Kux is FDA’s Assistant Commissioner for Policy