FDA Commissioner’s Global Health Lectureship: Focusing the Lens on Product Safety

Posted on January 22, 2013 by FDA Voice

By: Mary Lou Valdez

FDA is responsible for ensuring the safety and quality of tens of millions of foreign shipments of human food, animal feed, medical products and cosmetics that come into the United States every year. Many source countries are part of the developing world that is still forming its economic and industrial base. Thus, we have strong public health interests in making sure that the countries of origin have effective systems of regulatory oversight.

Strengthening the ability of developing countries to regulate their industries could also produce tremendous benefits for the health and quality of life of individuals and communities in those countries. Additionally, the development of stronger regulatory systems in other countries can bolster other U.S. government investments in public health, trade and economic development.

To enhance FDA’s knowledge of global public health trends, the Office of International Programs launched The Commissioner’s Global Health Lectureship in 2010. The lectureship invites highly respected and recognized leaders in global health to speak to FDA staff, and help the agency explore its role as a public health agency of the 21^st century and consider the critical functions of regulatory science and systems that contribute to improved public health.

Participating thought leaders have included:

Julio Frenk, M.D., M.P.H., Ph.D., Dean of the Harvard School of Public Health
Margaret Chan, M.D., Director-General of the World Health Organization
Sir George Alleyne, M.D., Director Emeritus of the Pan American Health Organization
Maria Freire, Ph.D., former President of the Albert and Mary Lasker Foundation and now President of the Foundation for the National Institutes of Health
Nils Daulaire, M.D., M.P.H., Director of the Office of Global Affairs, U.S. Department of Health and Human Services
Trevor Mundel, M.D., President of the Global Health Program, Bill & Melinda Gates Foundation

These lectures have inspired FDA staff to remain vigilant in protecting U.S. consumers and patients from harmful products, and to take action globally. For example, following Dr. Chan’s lecture, FDA is working with WHO and its member states on a long-term strategy for strengthening the review of applications for new pharmaceutical products and vaccines.

Similarly, as a result of Dr. Mundel’s lecture, FDA and the Gates Foundation have committed to developing key messages on the strengthening of regulatory systems that the foundation and the agency can consistently and collaboratively deliver to governments and public or private institutions. Here, the Gates Foundation, through its investments in product development partners, supports research and development of medical products to treat diseases affecting poor and vulnerable populations in developing countries. Strong regulatory systems are also essential to ensuring that these products meet science-based quality and safety standards before they are approved for sale, and can be monitored afterwards. The Gates Foundation recognizes the need for regulators to make informed decisions about what products enter their markets.

Our Global Health Lectureship has provided—and with future speakers will continue to provide—opportunities for FDA staff to engage in issues in new and unique ways, changing the agency’s global lens as we work to expand the product safety net all over the world. To learn more about FDA’s global strategies, read the “Pathway to Global Product Safety and Quality.”

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

World AIDS Day

Posted on November 30, 2012 by FDA Voice

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

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

Posted on November 27, 2012 by FDA Voice

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

National Mammography Day: Supporting Quality Mammography

Posted on October 19, 2012 by FDA_Voice

By: Marsha B. Henderson, M.R.C.P. and Helen Barr, M.D.

Like millions of women, we go each year to get a mammogram. For us the experience is not just about healthy living. It is also a reminder of the value of our hard work at FDA. Each time we see the FDA certificate in our mammography facility showing that the facility meets FDA’s high standards, we are reminded of the commitment and dedication of FDA employees to supporting mammography services.

Marsha B. Henderson, M.R.C.P. (left) and Helen Barr, M.D.

Under the Mammography Quality Standards Act and Program, FDA employees work to ensure that women can go anywhere in the country and expect to get reliable, high quality breast images. We certify and inspect mammography facilities establishing uniform standards for mammography equipment and staff training. Thanks to these efforts, there are over 8,600 certified mammography facilities in rural and urban communities across the country.

We didn’t stop there. Early on, we realized that regulation was only part of what was needed. FDA recognized that it should also help raise awareness about the importance of mammography. Through the Pink Ribbon Sunday Program, we formed outreach partnerships to teach women the facts about mammography screening. When the Pink Ribbon Sunday Program began in the 1990s, we targeted African American and Latino women because they were least likely to get a mammogram. However, the program quickly spread from minority churches to businesses, sororities, health centers, and other national organizations reaching women from all backgrounds.

Over the years, FDA has touched millions of lives through our mammography initiatives. We have chosen today – National Mammography Day – to thank our colleagues at FDA and our partners in the health care community and state and local governments for their efforts. We also encourage you to help connect the women in your community to our free mammography resources. Your efforts can help raise awareness, provide hope, and maybe even save a life.

Marsha Henderson, M.C.R.P., is FDA’s Assistant Commissioner for Women’s Health in the Office of the Commissioner

Helen Barr, M.D., is FDA’s Director of the Division of Mammography Quality Standards at the Center for Devices and Radiological Health

FDA’s Mini-Sentinel exceeds 100 million lives (and counting)… A major milestone in developing a nationwide rapid-response electronic medical product safety surveillance program

Posted on June 29, 2012 by FDA_Voice

By: CDR Melissa Robb

Having secure access to the electronic healthcare data of patients is an essential 21^st Century tool for detecting potential safety problems with medical products once they are in common use.

This is because studies conducted prior to approval may not be able to detect rare problems or problems that might emerge following long-term use of a product.

Congress recognized this need for additional information in the FDA Amendments Act (FDAAA) of 2007 when it authorized FDA to develop a nationwide rapid-response electronic surveillance system for monitoring the safety of FDA-regulated medical products such as drugs, vaccines, other biologics, and medical devices. FDA calls this the Sentinel System.

Now FDA is proud to report that it has met and EXCEEDED the legislation’s goal of achieving secure access to data from 100 million patients by July 1, 2012. In fact, FDA met that goal in December, 2011, and currently has secure access to data concerning approximately 126 million patients nationwide derived from 17 different data partners.

To better understand how the Sentinel System will work, FDA has been conducting a pilot program, dubbed “Mini-Sentinel,” that incorporates access to these 100 million-plus records. So far FDA has used Mini-Sentinel to conduct more than 120 data requests to gather safety information on various medical products.

As an example of the promise of this system, consider FDA’s recent use of the Mini-Sentinel pilot to help inform our ongoing safety analysis of the blood pressure drug olmesartan. FDA had received reports through our Adverse Event Reporting System (AERS) suggesting that olmesartan was associated with more cases of celiac disease than other “sartan” drugs in its class (losartan, irbesartan, telmisartan, valsartan). Celiac disease is a potentially dangerous condition in which the small intestine is damaged and the patient cannot absorb nutrients. FDA, through Mini-Sentinel, submitted a query request to the data partners for specific information on the number of patients with celiac disease who had taken these drugs. The resulting data report allowed FDA to determine that celiac disease did not occur significantly more often with patients who had taken olmesartan than with those who had taken other “sartan” drugs.

While the Sentinel System holds much promise, it is intended to supplement, not replace, FDA’s existing safety surveillance tools, including AERS, which relies on individual reports filed by manufacturers, health care providers and patients. When weighing risk against benefit of a medical product, FDA compiles information from a variety of sources before making a regulatory decision.

FDA is committed to maintaining the highest world-wide standards of safety surveillance capabilities. The Sentinel System is our next step forward towards that goal. Stay tuned. As always, we’ll keep you informed on progress.

CDR Melissa Robb is FDA’s Associate Director for Regulatory Affairs, Office of Medical Policy Initiatives

User Fees: Ensuring a Stronger and Better FDA

Posted on June 26, 2012 by FDA_Voice

By: Margaret Hamburg, M.D.

FDA receives thousands of applications for potentially promising medical products every year. Reviewing these often scientifically-complex submissions is the responsibility of a large team of doctors, chemists, bioengineers, statisticians and other experts who must determine whether a proposed new product is safe and effective for patients, and do so within a certain time period.

It takes steady and reliable funding to maintain and support a staff of trained reviewers capable of accomplishing this vital task. We’re gratified that Congress agrees, as demonstrated by today’s passage of the Food and Drug Administration Safety and Innovation Act in the US Senate by a vote of 92-4. Since the House of Representatives passed the bill last week by a voice vote, the bill now heads to the President’s desk, where it is expected to be signed into law. This legislation, when enacted, will authorize the FDA to collect user fees from industry to fund the review of innovator drugs, medical devices, generic drugs and biosimilar biologics.

Such overwhelming support for FDA user fees is a testament to the important role FDA plays in America’s healthcare continuum. FDA’s medical product decisions sit at the intersection of public health, innovation, and commerce and touch the lives of nearly every American every day.

Today’s positive vote also reflects the success of FDA’s commitment to transparency and collaboration in developing user fee proposals that all sides could support. FDA negotiators spent months in discussions with industry and consulted closely with patients, consumers and health care providers before arriving at proposals for each of the four programs.

Driving these discussions is the recognition that user fees have been a big success, reversing what was once a lag in the time needed for drug approvals. Since the prescription drug user fee legislation (PDUFA) was enacted in 1992, time to market for priority drugs has decreased from an average of 2 years to 1.1 years recently. This has provided patients faster access to over 1,500 new drugs and biologics, including treatments for cancer, infectious diseases, neurological and psychiatric disorders and cardiovascular diseases.

Under PDUFA V, fees paid by industry will support continued timely review of new prescription drugs, increase the use of standardized electronic data in product submissions, enhance communications with companies during drug development and implement a structured benefit-risk framework in drug review. PDUFA V also puts more focus on regulatory science, which seeks to create new tools, standards and approaches for use in assessing the safety, effectiveness, quality and performance of products. Among other things, user fees will advance the development of drugs for rare diseases and encourage the development of biomarkers.

Patient groups in particular are heralding PDUFA V as a turning point because it acknowledges that patients who live with a disease have a direct stake in the outcomes of the drug review process and are in a unique position to contribute to the entire drug development enterprise, including FDA review and decision-making. Thus, PDUFA V will support the advancement of the use of patient-reported outcomes and other tools to assess clinical trial endpoints that can improve quality and reduce risks in drug development. It will also engage patients to obtain their perspective about disease severity and unmet medical needs in a therapeutic area. FDA will use this perspective to inform the context in which the agency weighs drug benefits and risks.

The legislation also reauthorizes the user fee program for medical devices for the third time. Under MDUFA III, user fees will nearly double, rising from 20 percent of the total of FDA’s review activity to 35 percent. The agreement facilitates more timely access to safe and effective devices with the shared goal of reducing average total time to decisions and achieving greater transparency, consistency, predictability and productivity. With the additional funding, the FDA will be able to hire over 200 full-time equivalent workers by fiscal year 2017.

Two other user fee programs in the legislation are new. User fees for generic drugs or GDUFA will address our current generic drug review backlog caused by the increase in generic drug applications, their growing complexity, and the number of generic drug facilities now located overseas where inspections are more challenging. The added money from user fees will reduce this backlog and eventually ensure that FDA is able to inspect overseas facilities as often as it does domestic facilities.

The second new user fee program, BsUFA, would collect fees for products under development shown to be “biosimilar to” or “interchangeable with” an innovator FDA-licensed biological product. The funds would support early meetings with companies.

The legislation also contains dozens of other provisions related to FDA.
Three provisions are worth highlighting: they provide FDA with new tools to better combat drug shortages, ensure the safety and security of the drug supply chain and encourage drug innovation.

It’s been a long, yet productive process since FDA first began meeting with industry and other public stakeholders on the reauthorization of user fees nearly two years ago. What has emerged, I believe, will truly result in a stronger and better FDA for everybody.

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

The Triage Pilot: Increasing Efficiencies for Device Review

Posted on April 17, 2012 by FDA_Voice

By: Alberto Gutierrez, Ph.D.

In the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification (510(k)) submissions sooner than expected. This will be due to a six-month pilot program called Triage, launched recently by FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, a part of the Center for Devices and Radiological Health (CDRH).

The goal of Triage is to improve efficiencies in the review process. Reviewers will focus more of their time and attention on higher-risk and novel devices, like companion diagnostics, and less time on devices that are lower-risk and have well-known and well-understood safety and effectiveness profiles.

As the name “Triage” suggests, when certain 510(k) submissions are submitted, reviewers will make an assessment of the level of resources needed to complete a review, based on a quick assessment of the submission’s content and completeness. High-quality submissions that meet certain criteria and contain all of the information needed for a substantial equivalence evaluation will be slated for a 30-day Quick Review. Those 510(k) submissions not meeting these criteria would receive the standard review (generally 90 days) consistent with user fee performance goals.

To qualify for a 30-day Quick Review, the 510(k) submission must:

be well-written, organized and contain all expected data and information to support substantial equivalence claims;
be for a device that is well-known to FDA;
be for a device that does not have existing or unresolved postmarket issues;
not require an extensive review by a subject matter expert other than the reviewer assigned to the submission; and
contain a 510(k) Summary, which is a summary of the information used to support the substantial equivalence determination.

And even with time saved, the Triage pilot program will preserve the quality and transparency of the normal 510(k) review process. Reviewers will still assess the same elements as they would in a standard review, but instead will accomplish it within 30 days. If the device is found to be substantially equivalent to a legally marketed predicate device, the 510(k) Summary will be posted online, allowing the public to see FDA’s basis for the substantial equivalence determination.

At the end of six months, FDA plans to evaluate and refine the program. The evaluation will provide us with some simple metrics on 510(k) review times and use of resources, but the impact, we hope, will go beyond the numbers.

For manufacturers, healthcare practitioners and patients, faster reviews will mean some products will be available sooner. For FDA staff, the time saved by using Quick Review can be devoted to reviewing submissions for higher-risk devices and novel technologies and to expanding their knowledge and expertise in new and emerging science. Depending on the pilot’s outcome, CDRH may consider expanding the Triage program to other device types besides in vitro diagnostics and radiology products.

Facilitating access to safe and effective devices is a goal shared by FDA, manufacturers, the healthcare community, and the public. We’re optimistic that our innovative Triage pilot program can help us meet that goal and that industry will see the possibility of a 30-day review as additional incentive to submit high quality 510(k) submissions.

Alberto Gutierrez, Ph.D., is Director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, a part of the Center for Devices and Radiological Health

Balancing Innovation and Safety: FDA’s Innovation Pathway

Posted on April 9, 2012 by FDA_Voice

By: Jeffrey Shuren, M.D., J.D.

Over the past couple of years, there has been a lot of discussion about balancing innovation and safety—whether we need to have more regulation of medical devices to assure safety and effectiveness—or whether we need less regulation of medical devices to foster innovation.

FDA’s Innovation Pathway is an exciting example of how innovation and safety and effectiveness don’t have to exist on opposite ends of a swinging pendulum. They can be complementary, mutually supporting aspects of our public health mission.

The goal of the Innovation Pathway is to reduce the overall time and cost it takes for the development, assessment, and review of safe and effective medical devices that address unmet medical needs, so these devices can get to the patients who need them sooner without jeopardizing patient safety.

Another goal is to improve how FDA and innovators work together. We can achieve that with our new Innovation Pathway through earlier engagement and more collaboration.

We’re also experimenting with new ideas—creating sort of a living laboratory or incubator. Through the Innovation Pathway, we are developing and rapidly testing new approaches to pre-market review including the use of a decision support tool that will help assure that the regulatory decisions we make about whether or not to approve early clinical studies are more transparent and consistent. Such a tool can help us decide, for example, whether there is sufficient evidence to allow the device to be studied for the first time in humans.

Additionally, we’re implementing a new suite of information technology tools that will improve FDA’s communication with sponsors.

Like any strong and successful business, when we find an approach that works—in this case, when tested in the Innovation Pathway—we will roll it into our existing processes for other devices where it adds value, thereby leading to improvements in all of our pre-market programs. When an approach doesn’t work, we will throw it out and move on.

And, one of the unique ways we’ve developed the Innovation Pathway is through the Entrepreneurs in Residence (EIR) program, which is supported by the White House Office of Science and Technology as a component of the Administration’s Strategy for American Innovation. The EIR program brought together experts outside FDA to work with agency staff and leadership to develop the Innovation Pathway 2.0.

Today we are very excited to announce that three innovators with products for patients with end stage renal disease – ESRD – have been chosen to participate in our Innovation Pathway 2.0. We received 32 applications in response to our January call for innovative treatment technologies for ESRD. Later this year, we may accept additional applicants from the ESRD challenge onto the Innovation Pathway.

We chose to focus on ESRD because of its public health impact—more than half a million Americans suffer from ESRD—and because management of ESRD is largely dependent upon medical device technology, such as hemodialysis equipment. Most dialysis patients spend long hours in specialized outpatient clinics, lowering quality of life and reducing their productivity. In addition, Medicare covers some 75 percent of ESRD health care costs, which in 2009, topped $29 billion.

We think the Innovation Pathway can help medical technology reach patients with unmet medical needs such as those suffering from ESRD. But, equally as important, we want to apply what we learned from our Innovation Pathway experience throughout our device review processes.

It’s vital to understand the Innovation Pathway does not lower our standards for medical devices. The U.S. standards of reasonable assurance of safety and effectiveness and of relying on valid scientific evidence have served patients and industry well. The Innovation Pathway 2.0 illustrates that there are ways to facilitate innovation without compromising our standards and patient safety.

Jeff Shuren is the Director of FDA’s Center for Devices and Radiological Health

Diagnosing TB, One Test at a Time

Posted on March 19, 2012 by FDA_Voice

By Alberto Gutierrez, Ph.D.

For centuries tuberculosis, or simply TB as it is commonly referred to today, was fatal for millions of people living around the world. Most people infected with the bacterium Mycobacterium tuberculosis, the most common cause of tuberculosis, show no symptoms of TB. However, approximately 10 percent of those infected, such as those with weakened immune systems, will develop active TB disease. With active disease, the bacteria generally attack a person’s lungs, but can also attack other parts of the body such as the kidney, spine, and brain. Tuberculosis is spread through the air when a person with active TB disease of the lungs or throat coughs, sneezes, or speaks. People who are close by may breathe in the bacteria and become infected.

The most common symptoms associated with active TB disease include: a persistent cough lasting for three weeks or longer, chest pain, weakness or fatigue, weight loss, night sweats, and fever. People infected with TB who also have weakened immune systems have a much higher risk for not containing the bacteria and developing active disease, which can be fatal if left untreated. Today, the disease is also a leading killer of people with HIV worldwide.

Past and present experiences have taught us that the proper diagnosis of TB is critically important in order to prevent the spread of TB.

For our part, the agency recently announced plans to lower the risk classification for nucleic acid-based TB tests used to detect the presence of copies of tuberculosis bacterium genetic materials (RNA or DNA) in a mucus (sputum) sample obtained from the person. This type of test allows for the timely identification of TB disease.

These tests can diagnose active TB infections in one to two hours and when used in conjunction with other clinical tests, can result in earlier treatment, improved patient outcomes, and interrupt further spread of TB.

The FDA currently considers nucleic acid-based TB tests high-risk (Class III) medical devices that require the agency to conduct a rigorous review to verify the product’s safety and effectiveness before they are used with patients. Under the new proposal, these tests would be considered moderate-risk (Class II) devices.

While the pathway to market would be considerably shorter, given the importance of these tests, the agency has still provided guidance to the developers of these tests that identifies the risks associated with false positive and false negative test results, the risks to health care workers handling specimens, and makes recommendations on how to mitigate these risks.

It is the FDA’s hope that this more streamlined and flexible regulatory approach will ultimately encourage the development of new and more innovative TB diagnostics that will aid us in our fight to prevent the spread and hopefully one day, eliminate the presence of TB.

Alberto Gutierrez, Ph.D., is the Director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health

FDA Voice Interviews Stephen Spielberg, MD, PhD

Posted on January 25, 2012 by FDA_Voice

FDA Voice: Dr. Spielberg, thank you for agreeing to let us interview you for FDA Voice. Can you tell us about your position at FDA and what that entails?

Dr. Spielberg: I am the Deputy Commissioner for Medical Products and Tobacco. In creating this new position, Commissioner Hamburg envisioned that it would “provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products, and support, coordinate and advocate for the work and needs of the Centers.” In my short time at FDA, I have been working with the Center Directors and their staff to understand shared challenges and opportunities to advance regulatory science and practice across all “human products”. Together, we have begun to define areas of mutual interest and synergy where we can work together and with external partners in the public and private sectors to bring the best of science to bear on our public health responsibilities, to advance managerial and operations support to optimize our core tasks, and to assure in everything we do that FDA is at the cutting edge of promoting and protecting the public health.

FDA Voice: Why did you join FDA?

Dr. Spielberg: Throughout my career, I have been involved with FDA. In fact, my MD-PhD training at the University of Chicago, particularly in the Department of Pharmacology, was in the context of former UC faculty (Drs. E.M.K. Geiling and Francis Kelsey) who were intimately involved with creation of FDA by their work on elixir of sulfanilamide (Federal Food, Drug, and Cosmetic Act of 1938) and thalidomide (Drug Amendments of 1962). So, in retrospect, I suppose I “grew up” with knowledge and appreciation of FDA. Over the years, I have served as a member of the Pediatric Subcommittee, the Science Board, rapporteur for ICH E-11, and helped get BPCA and PREA through Congress. At this stage of my career, it is a true honor for me to be able to serve the Agency at a critical time in biomedical science and therapeutics.

FDA Voice: What did you do before joining FDA?

Dr. Spielberg: I have had a 35 year career as a pediatrician and clinical pharmacologist, including in academic settings in the US and Canada, as well as in the pharmaceutical industry. My research career has focused on human pharmacogenetics and pharmacogenomics, mechanisms of adverse drug reactions, and pediatric/development pharmacology and pediatric clinical trials. In the years prior to coming to FDA, I was Dean of Dartmouth Medical School, and subsequently headed a new personalized medicine program at Children’s Mercy Hospital in Kansas City, MO, as well as working with the Institute for Pediatric Innovation, a non-profit organization focused on advancing therapeutics for children.

FDA Voice: What is the favorite part of your job here at FDA?

Dr. Spielberg: This is a remarkable time to be at FDA. Biomedical science is advancing at an incredible rate. We are now beginning to see the impact of genomic and other science in defining the causes of disease, and in the discovery and development of new therapies. Medicine now is at a place that I could barely have imagined when I began my career, but we have the age old challenges of how to skillfully and wisely use the knowledge we have at any time to advance the health of individual patients and of all patients we serve. At such a time, what could be more challenging and satisfying than being here at FDA and having the opportunity to advance the promotion and protection of the public health.

FDA Voice: If you could tell the American public one thing that you think they don’t know about what your office does to directly benefit them, what would it be?

Dr. Spielberg: Every day, I am impressed by the outstanding, dedicated, hard working people here at FDA. Their focus on our public health mission is remarkable, and it is an honor to work with them.

FDA Voice: Dr. Spielberg, thank you so much for your time!

Stephen Spielberg, MD, PhD, is Deputy Commissioner for Medical Products and Tobacco