World AIDS Day

By: CDR. Steve L. Morin, R.N., B.S.N.

World AIDS Day has been observed in the United States on December 1 since 1995. When I look back at early World AIDS Day observances, I remember them as a way of raising awareness of the men, women and children who had no advocates, no representation, no medicines, and practically no hope. They eventually died from the disease early in the epidemic.

In the beginning, World AIDS Day was an important platform for the HIV/AIDS community to help raise awareness among the many people who had never known or even met anyone living with HIV/AIDS. In those early years, the focus was on finding a treatment and keeping those diagnosed with the disease alive. 

Last year marked 30 years since AIDS was first reported in the Center for Disease Control and Prevention’s Mortality and Morbidity Weekly Report (MMWR), emerging as a permanent part of our lives. Today, when I think about World AIDS Day, I think of it as a day to acknowledge how far we have actually come in the fight against HIV/AIDS. We’ve come so far—not only in treatment, but also in preventing new infections, and reducing or eliminating the stigma associated with this disease. 

The Food and Drug Administration supports the fight against HIV/AIDS by promoting medical innovation, protecting the blood supply, and reviewing and regulating new and existing medical products, including devices used in prevention, such as condoms and medical gloves. Doctors, nurses, pharmacists, scientists and many others at FDA have worked hard in 2012 to make sure that there are safe and effective medical products and devices available to fight HIV/AIDS. I am happy to say that this year there were four major advances in the battle against HIV. 

  • Truvada is the first HIV drug approved for prophylactic (preventive) use. It has been shown to reduce the risk of sexual transmission of the HIV virus to uninfected adults.
  • OraQuick In-Home HIV Test is the first rapid home-use oral HIV test kit that does not require sending a sample to a laboratory for analysis. This test has the potential to identify previously undiagnosed HIV infections, especially if used by those unlikely to visit a doctor’s office or clinic.
  • Stribild is the first HIV medicine to combine four separate drugs and is the third HIV drug that can be taken once daily.
  • The number of antiretroviral drugs tentatively approved or approved for use under the President’s Emergency Program for AIDS Relief, or PEPFAR, has surpassed 150. PEPFAR is a program to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.

So today, as World AIDS Days approaches, I ask that you take a moment to remember the combined effort of patients, researchers, industry, FDA and other government agencies contributing to the successes in fighting HIV/AIDS. There are currently 36 approved therapies for treating HIV/AIDS in the United States. As new therapies are added to the list of treatments, patients’ quality of life has improved, with fewer side effects and simpler therapeutic regimens that make adhering to therapy easier. People living with HIV are now able to focus on life rather than death. Until there is a cure, we will continue to work together for an AIDS-free world.

CDR. Steve L. Morin, R.N., B.S.N., is a Health Programs Coordinator in FDA’s Office of Special Health Issues

Global Cooperation Helps Expand Safety Net

By: Margaret A. Hamburg, M.D.

En Español

Em Português

Ensuring that the millions of FDA-regulated products that flood into the U.S. from 150 foreign countries every year are safe and effective can be daunting task. That’s why it was heartening for me to sign two cooperative arrangements this week with some of our international partners that will make this task a little easier. The arrangements also represent encouraging developments in the quest for a global safety net created through international cooperation.

One arrangement, a “Statement of Cooperation” with FDA’s counterpart in Brazil, outlines procedures for enhanced collaboration between our nations on common regulatory issues. The arrangement is particularly critical at a time when Brazil is dramatically increasing its trade with the U.S. The U.S.imported $31.4 billion worth of products (both FDA-regulated and not regulated) from Brazil last year — an increase of 126% from 2000.

Top regulatory officials from four countries, meeting at a summit in Brazil, prepare to sign the “Statement of Cooperation” among their respective agencies. They are, left to right, Paul Glover, assistant deputy minister of Canada’s Health Products and Food Branch, Margaret A. Hamburg, M.D., commissioner of the U.S. Food and Drug Administration, John Skerritt, national manager of Australia’s Therapeutic Goods Administration, and Dirceau Barbano, director chairman of Brazil’s National Agency for Sanitary Vigilance.

The second arrangement, a “Statement of Cooperation” is between the FDA and our regulatory counterparts in Australia, Brazil and Canada. The arrangement creates stronger regulatory oversight that is less burdensome for both industry and regulators as we pool resources to cover a larger global array of medical device manufacturers.

I signed both arrangements while in Manaus, Brazil, in the heart of the Amazon River basin. The heads of counterpart regulatory agencies from around the world had come together to collaborate on ways to help better ensure the safety of products in all countries—an approach we refer to as the global safety net. Thus, this summit was a particularly appropriate occasion for signing these two arrangements.

The already difficult job of ensuring the safety of FDA-regulated products has grown exponentially due to two megatrends: the expansion of global trade, and the need for ever-greater expertise from regulators as innovations bring increasingly sophisticated products to market.

Our strategy is to create coalitions of regulators that bring together the best minds from around the world to work on the common goal of improving product safety and quality. As I outlined in a keynote address I delivered at the conference, we need to develop a strategy that moves us towards routine regulatory coherence and mutual reliance with our regulatory counterparts. While maintaining national sovereignty and individual agency decision-making responsibility, we can do much more to share regulatory information, strategies and resources.

The arrangements I signed while in Brazil stood as concrete examples of the broader concepts discussed at the conference.

The arrangement between the FDA and regulatory agencies in Australia, Brazil and Canada provides for the creation of a single audit program for medical device quality management systems. The four countries, in accordance with their respective legal authorities, would develop a plan to audit, or inspect, a device facility and then the other countries would utilize the regulatory findings.

The four countries also pledged to promote greater global alignment of regulatory approaches and technical requirements.

Standardized oversight procedures will bring more consistency, predictability and transparency to the regulatory process.

FDA Commissioner Hamburg and Dirceau Barbano, director chairman of the National Agency for Sanitary Vigilance in Brazil, review a “Statement of Cooperation” between their respective agencies.

The broad arrangement between Brazil and the U.S. includes a number of provisions. Both countries will consider exchanging information collected during investigations or facility inspections. They will also identify research that supports the scientific basis for regulations and actions.

What is expected is increased understanding of each other’s regulatory systems and an opportunity to explore how to leverage each country’s resources to expand the safety net for both countries.

The arrangements, and the conference, are steps towards a future with better outcomes through global cooperation. I was pleased to be a part of it.

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


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

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

Store Medicines Safely While Traveling

By:  Dale Slavin, Ph.D.

Are you traveling during the holiday season?

In addition to planning where you’re going to stay and what you’re going to do, there is another important consideration: How are you going to store your medicines and vitamins in a way that will keep them out of the hands of young children in your family or the friends or family you’re visiting?

More than 60,000 young children are brought to emergency rooms each year after taking a medicine not intended for them. In recent years, the number of accidental medicine overdoses in young children has increased by 20 percent. Swallowing an adult-strength vitamin can also endanger a child’s health.

To reduce accidental exposure to medicines, FDA has been working on an initiative called PROTECT, led by the Centers for Disease Control and Prevention (CDC). The initiative has created the Up and Away and Out of Sight educational program to help parents understand how to store and safeguard medicines.

With people planning holiday vacations, we want to remind parents and caregivers that they must also take precautions to make sure that kids don’t get into medicines when they’re staying in a hotel or are guests in someone else’s home. A few simple steps followed every time can protect small children.

FDA, CDC, and the PROTECT Initiative have these tips for safely storing medicines while traveling:

  • Put medicines away every time you use them. Remember to never leave medicine or vitamins out on a table, countertop, bedside table, or anywhere your children could reach them.
  • Store your medicines in their original child-resistant containers. Other containers, such as pill organizers and baggies, often lack child-safety features.
  • Always relock the safety cap on a medicine bottle. If it has a locking cap that turns, twist it until you hear the click.
  • While staying in a hotel, secure your medicines and vitamins in a location that your children cannot see or reach, such as a high cabinet or passcode-protected hotel room safe.
  • As a guest in another person’s home, don’t be shy about asking where you should put your medicines and vitamins, and remind others to keep their purses, bags, and coats that have medicines in them up and away and out of the sight and reach of children.
  • Program the national Poison Help number (1-800-222-1222) and other emergency contact numbers into your cell phone so you will have them when you need them. Poison Help Information is online at

Dale Slavin, Ph.D., is Acting Director, FDA’s Safe Use Initiative, which works to reduce preventable harm from medications

Helping Authorities Prepare for a Food-Related Emergency

By: Jason Bashura, M.P.H., R.S.

FDA has prepared a valuable tool that will help its regulatory and public health partners at the state, local, tribal and territorial levels be prepared for disasters that could compromise the safety of the food supply. 

The Food Related Emergency Exercise Bundle (FREE-B) is a compilation of scenarios based on both intentional and unintentional food contamination events. These “table top exercises” can help government regulatory and public health agencies assess their food-emergency response protocols and procedures. Additionally, tools, resources and external links are provided within FREE-B to help in response planning.  

One of the goals is to mitigate the effects of a large scale food emergency. Agencies become like actors in a play, trying out different roles and seeing how well they perform in a given scenario. What are their strengths? Are there gaps in emergency response plans? What relationships must be strengthened to help protect the public’s health and well-being?

FREE-B can also aid agencies that are in the process of revising or developing food emergency procedures. It is designed to allow an agency to interact with multiple partners, such as the medical community, private sector companies and law enforcement. It can also be used by an individual agency to test its own procedures.

Five scenarios currently make up the FREE-B package:

  • How Sweet It Is(n’t) – The regulatory traceback investigation and recall that occurs after testing shows a food product contains high levels of lead. 
  • Stealthy Situation – The nuances encountered when a cluster of illness is associated with a foodservice establishment.
  • Wilted Woes – The epidemiological investigation to identify the contaminated food when there is an unintentional contamination of produce with E. coli O157:H7.
  • High Plains Harbinger – The investigation of animal disease caused by intentional infection of cattle with Foot and Mouth Disease virus, highlighting the roles of animal agriculture and law enforcement agencies during an animal health emergency.
  • Insider Addition – Raw meat has intentionally been contaminated with a chemical agent at the food processing facility.

FREE-B’s overall goal is to facilitate the taking of appropriate, timely and effective steps during emergencies caused by intentional or unintentional acts. It does this by:

  • creating dynamic teams to face critical food emergency incidents;
  • assessing readiness of all involved to effectively address a food contamination incident; and,
  • defining roles and interactions with government agencies and food industry organizations, including understanding the resources that each of these bring to the table.

Users of Free-B are encouraged to evaluate this toolkit and provide feedback to the Food Defense Oversight Team, so that future versions of the tool can better prepare our partners.

Industry, academia and non-government organizations can also benefit from participating in one of these exercises.  Food defense truly is everybody’s business.

Jason Bashura, M.P.H., R.S., is a health scientist on the Food Defense Oversight Team at FDA’s Center for Food Safety and Applied Nutrition

What is Regulatory Science?

What is regulatory science? And what does it mean to you and your family? Listen to top FDA officials and scientists explain the fields of research that make it possible for FDA to fulfill its mission of protecting public health. Regulatory science provides the evidence that FDA needs to know that products such as drugs, medical devices, vaccines, cosmetics and foods are safe for consumers. Regulatory science makes it possible for FDA to evaluate the safety and effectiveness of advancing technology, and to get innovative products to consumers as quickly as possible. It is difficult to count the number of ways in which this research affects the daily life of the average American consumer.

For more information about regulatory science, visit the Consumer Update series on this subject:

Why You Should Care About Regulatory Science

Personalized Medicine Will Fit You Like a Glove

FDA Targets Drug Side Effects

Emerging Technology Embraces the Future

Scientists Working to Keep Foods Safe

Fighting Antibiotic Resistance

By: Rachel Sherman, M.D., and Edward Cox, M.D.

This week is the annual Get Smart About Antibiotics Week, a national campaign sponsored by FDA, the Centers for Disease Control and Prevention (CDC) and other public health organizations, to highlight how important it is to use antibiotics wisely.

Antibiotic resistance is one of the world’s most pressing public health threats. Antibiotics are the most important tools we have to combat life-threatening bacterial diseases, but overuse of these drugs has led to the emergence of drug-resistant bacteria, or “superbugs.”

Key to combating antibiotic resistance is antibiotic stewardship, making sure we use the drugs appropriately—and only when needed—to help preserve their effectiveness in fighting bacterial infections. Doctors and other health care professionals should make sure that the antibiotic and dose they prescribe will be effective in treating the infection. And patients must be sure to take an antibiotic exactly as instructed by their prescriber and complete the entire course of treatment, even if they start feeling better. The way we use antibiotics today has a direct impact on how effective they will be in the future.

But as we take care to use existing antibiotics wisely, we realize that we will always need new antibiotics.  Bacteria will continue to evolve and develop resistance to the drugs we have now. Unfortunately, research and development for new antibiotics has been in decline in recent decades, and the number of new antibiotics has been falling steadily since the 1980s.

To address this decline, FDA recently established a new internal task force to help support the development of new antibiotics. The Antibacterial Drug Development Task Force is a multi-disciplinary group of FDA scientists and clinicians working with experts from all over the country to establish new ways of developing safe and effective new antibiotics.

We’ve already held several meetings to discuss the challenges to creating new antibiotics and explore possible solutions.  And although still in the early stages of meeting the challenges, as co-chairs of the task force, we are encouraged by the frank and open discussions we are having with experts from academia, industry, professional societies, patient advocates and our fellow government colleagues.

It will take time before new antibiotics are available to treat some currently resistant infections. But if we act now and work together, we can improve antibiotic use and preserve the effectiveness of these important medicines.

Rachel Sherman, M.D., M.P.H., is Associate Director for Medical Policy in FDA’s Center for Drug Evaluation and Research.

Edward Cox, M.D., M.P.H., is Director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.

Modernizing FDA’s Information Technology

By: Eric D. Perakslis, Ph.D.

As I look back at my first year as chief information officer and chief scientist (informatics) at FDA, I am gratified with all of the progress that has been made. But I am also eager to transform initial wins into consistent and sustained success.

My team at the Office of Information Management (OIM) manages and advances information technology at FDA. Our mission is to provide the organizational structure and services that allow the exchange of information, communication and knowledge that enhance and sustain FDA’s ability to protect and promote the public health.

Our vision is that FDA’s technology and knowledge capability is modern, secure, accessible, cost-effective, and exceeds customer and partner expectations.

Some of our early successes include important contributions to what we call the Innovation Pathways 2.0 initiative, which provides a rapid new way to submit breakthrough medical devices to FDA for approval. This in turn would get such products faster to the patients who need them.

OIM also completed 20 projects in very short time in support of the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law by President Obama in July 2012. Many of these projects strengthen the process of reviewing and approving important new medical products, while making that process more transparent to the tax-paying public.

In addition, this year we launched a new strategic effort to improve the overall “customer experience” with FDA’s information technology, customers in this case being FDA employees stationed all over the world. Our goal is to provide the technology to ensure that FDA employees can reliably perform their daily duties efficiently and timely regardless of location, whether they’re in an office or in the field, or at home working remotely.

And our improvements to the process of analyzing the health risks presented by medical products of all kinds have helped drive the modernization of the FDA inspection process. This helps ensure that the growing number of products we regulate have a higher level of safety and quality before they reach American consumers.

While these accomplishments are significant, there is still much to be done to modernize information technology at FDA.

The new FDA Information Management Strategic Plan sets the path forward. Its priorities include strengthening real-time connectivity and access to key data and information. This is essential for daily FDA operations and for our connections to the public we serve and to our many partners outside of the agency who depend on FDA for the execution of their own public health missions.

The Strategic Plan also focuses on the availability and usability of data essential to the speed and efficiency of decision-making at FDA. The intent of this goal is to facilitate a learning and knowledge network that will enable FDA to assess the potential risks of regulated products on a scale that routinely handles global sources and large volumes of data. 

Going forward, we will do our best ensure that FDA’s technological needs today and tomorrow are fully covered and in place. There is no more inspirational public health mission than that of the FDA. Every citizen of this great nation depends on us every day and we will never forget that. In many ways this Strategic Plan is as much about what we believe, and our commitment to our customers and mission, as it is about what we deliver.

Eric D. Perakslis, Ph.D., is FDA’s Chief Information Officer and Chief Scientist for Informatics

Regulatory Science Is Not Boring

By: Susan Kelly

I’m a relative newcomer to government work, joining FDA about 18 months ago after decades of being a journalist. My job is to assign, write and edit FDA Consumer Updates, news stories posted on that are designed to give consumers important information in language that’s easy to understand. Not too technical or bureaucratic.

To endear myself to my new colleagues, I decided to write about anything that we saw as boring, leaving them to write about the hotter topics. I’m not easily bored, so I thought this would work as a noble gesture.

Even with this resolve, my heart sank when I was asked to write about regulatory science – one of FDA’s highest priorities. Do you remember the character Chandler Bing from the TV show “Friends”? I could hear his voice in my head: “Could this BE more boring?”

But I resolutely set about my task and five Consumer Updates later, I’m here to tell you that regulatory science is NOT boring. Not even close.

The official definition: “Regulatory science is the science of developing new tools, standards and approaches to assess the safety, effectiveness, quality and performance of FDA-regulated products.”

Ok. Put down the remote and give me a minute.

FDA has a huge impact on your daily life. Think about the foods you eat, medicines you take, vaccines your kids are given, the medical devices as commonplace as band-aids and toothbrushes and as complicated as an artificial heart, the foods and medicines you give your pets. FDA’s job is to make sure that products like these, and many, many more, do what they’re supposed to do —and do it safely.

Regulatory science is the proof that’s in the pudding, so to speak. It’s how FDA collects the scientific evidence it needs to determine if a regulated product will actually make your life better. It’s how FDA collects the scientific evidence it needs to ensure that the foods you eat at home or in restaurants are safe to eat. (How they taste is not our problem.)

Regulatory science identifies and tracks nasty bacteria that contaminate food. It creates genetic tests to determine if medication could work for you specifically—not just for people who are like you in some way. It puts human cells on a computer chip that mimic the function of organ systems, thereby possibly reducing the need to test new drugs on animals.

It’s the virtual family—a scary looking group of computer models that scientists can use to see what medical devices would work for their patients.

I especially liked meeting the scientists. Some of them struck me as a bit eccentric, as you might expect. Others are shy and reticent. What they have in common is a genuine commitment to make the world a better place – a safer place.

So the next time that you read the words “regulatory science,” take a second look. The work that goes on under that banner could save your life someday.

Susan Kelly is the managing editor of Consumer Health Information at FDA.

We’re Working to Offset Ameridose Impact

By Margaret A. Hamburg, M.D.

Drug shortages are two words that no one wants to hear—not patients, not health care professionals, and not me.

Margaret Hamburg, M.D.FDA has been working hard to prevent and mitigate drug shortages. In 2011, the number of medications in short supply hit 251. Addressing drug shortages must be a top priority for us at FDA because these are medications that people need to stay healthy, to treat their illnesses, and even, in some cases, to stay alive.

This year, we’ve taken significant steps to expand our efforts and to engage in new ways with industry. Between Jan. 1 and Sept. 30, 2012, FDA worked with drug manufacturers to help avert the shortage of 145 drugs. Many critical medicines used to treat cancer and conditions such as attention deficit hyperactivity disorder (ADHD) are no longer in short supply.

However, drug shortages are still a serious problem, one that may be temporarily impacted by Ameridose LLC’s voluntary recall of all of its unexpired products. Ameridose, located in Westborough, Mass., is managed by some of the same people as the New England Compounding Center—which produced the drug that is implicated in the deadly, multi-state outbreak of fungal meningitis. An inspection of Ameridose was initiated as part of FDA’s ongoing investigation of the outbreak.

FDA recommended that Ameridose recall its sterile drugs because we could not be assured of the sterility of those products. However, this recall may affect supplies of certain life-saving drugs for some health care systems. FDA has identified a number of Ameridose products—including drugs used during surgery and to treat medical conditions that include congestive heart failure—that were on the current drug shortages list before the recall.

We also know that the supply of other drugs may be affected by the Ameridose recall. That’s why FDA is taking proactive steps to minimize the impact this recall may have on current drug shortages, and to prevent other shortages from occurring.

For recalled medications on the current drug shortages list, FDA is taking the same actions it has used successfully to mitigate other shortages.

  • FDA is working with manufacturers of these drugs, requesting that they ramp up production if they are willing and able to do so.
  • For any manufacturers of these drugs that may be experiencing manufacturing or quality problems, FDA is offering assistance to enable them to produce shortage drug products that are safe and high quality.
  •  As with shortages of any critical products, FDA will expedite the reviews of any pending applications that could help with addressing the shortages.
  • FDA is identifying any additional manufacturers willing to initiate or increase production.
  • If manufacturers of critical drugs are not able to meet U.S. patient needs, FDA will explore overseas companies that are willing and able to import foreign drugs to address the shortage. In these instances, FDA evaluates the imported drug to ensure that it is of adequate quality and that the drug does not pose undue risks for U.S. patients.

Since the beginning of the year, the number of advance notifications to FDA of potential shortages has greatly increased. If we know that a problem is on the horizon, we’re able to proactively work with industry, organizations, patients and stakeholders to address it. We have doubled the number of staff members who work in drug shortage prevention and response.

We at FDA are committed to doing everything we can, using all available tools, to prevent or mitigate drug shortages and help keep critically needed products on the market.

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