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

FDA: Reflection on 2011 and Looking Forward to 2012

Posted on January 4, 2012 by FDA_Voice

By: Margaret A. Hamburg, M.D.

The beginning of a New Year is a wonderful time to reflect on the past year and to think about what lies ahead. While 2011 had its share of challenges for us at FDA, it was also a time of significant accomplishment. We are excited about the many opportunities that 2012 will bring to the Agency.

2011 began with the most sweeping reform of our food laws in more than 70 years. FSMA promises an even safer food supply than we enjoy today and a wonderful opportunity to help promote public health. We also continued the hard work of implementing the Family Smoking Prevention and Tobacco Control Act.

On the medical product front, there were a multitude of outstanding activities and advances. Importantly, we renewed our focus on the importance of innovation, in our own work and in the products we are tasked to review. This was also a remarkable year for innovative drug approvals. During Fiscal Year 2011, the FDA approved 35 novel drugs, targeting diseases such as late-stage lung cancer, metastatic breast cancer, and hepatitis C.

We also worked to continually strengthen the science that guides our policies, including many important collaborations with key partners and stakeholders. Even with all of our ongoing work, when crises came in 2011, we acted swiftly to protect the American people. We also continued to strengthen our capacity to address one of the greatest challenges in this new century – our increasingly globalized world. “Pathway to Global Product Safety and Quality”

In 2012, FDA will meet new and complex challenges and continue our work in implementing FSMA and the Tobacco Act, promoting advancements and innovation in medical products, and broadening our strategic globalization and regulatory science initiatives. We will be working closely with Congress and stakeholders to support the reauthorization of user fees for pharmaceutical products (PDUFA), and medical devices (MDUFA), as well as to authorize new user fees for generic drugs (GDUFA) and biosimilars.

I am confident, thanks to the dedication of the employees of the FDA, that we will continue to make invaluable contributions to the lives of you, the American people.

I wish you and your family a healthy and happy 2012.

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

Answering the Device Industry’s Call for Clarity

Posted on December 27, 2011 by FDA_Voice

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

Have you ever had to puzzle through opaque instructions for operating some electronic gizmo? It can be a frustrating, time-consuming process.

Sometimes that’s how the medical device industry views FDA. They clamor for greater
clarity on a variety of agency programs, as we began to learn in 2009 when the FDA’s
Center for Devices and Radiological Health started taking a look at our pre-market
programs.

We reached out to industry during that process and they told us one of their primary concerns was a lack of clear guidance. They said their companies depend on a clear regulatory pathway to avoid unnecessary costs and bring new, safe and effective devices
to market in a timely manner. We listened, and in January, when we announced our plan to improve our pre-market programs, issuing clear guidance was an integral part of our plan.

Since then, we’ve issued several clarifying guidance documents including one on clinical trials and another on the evaluation of “de novo” devices – novel lower-risk devices. Now, as the year comes to a close, we’re out with three additional draft guidances. One outlines the process for appealing CDRH decisions. The second explains how product codes should be developed and used. And the third helps clarify how FDA decides whether a device is “substantially equivalent” to a legally-marketed device under the 510(k) program. Every year some 4,000 lower-risk devices are cleared for marketing using this streamlined process, the most common pathway to market for medical devices. This latter guidance on substantial equivalence addresses what information should be in a submission, explains how the FDA decides whether clinical data should be required, and provides a decision-making flow chart to help manufacturers through the application process, an approach we know is popular with industry. Importantly, it does not alter our review standards, the 510(k) review processes, or the agency’s data requirements. Instead, it makes the existing regulatory framework more transparent and predictable by clearly articulating many of the longstanding practices and policies underlying the 510(k) program.

At 116 pages, the substantial equivalence guidance is admittedly long, so we’ll be
offering a free online training program to walk industry through the document’s various
segments. And, like all of the other guidance we’ve issued this year, it is just draft. That
means it’s not written in stone; we’re actively soliciting feedback from industry and other
interested stakeholders.

As I look back over 2011, I can report that we have made significant progress on the
actions we committed to take this year to improve our pre-market programs. To see for
yourself, just follow this link to a table that charts our accomplishments.
Once these policies and processes are finalized and implemented, we expect to see a significant and positive impact on the pathways to market for medical devices.

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

FDA Voice

Posted on December 23, 2011 by FDA_Voice

By: Margaret Hamburg, M.D.

I’d like to introduce you to FDA Voice – FDA’s newest communications vehicle designed to give you information from behind the scenes here at FDA, and in our own words.

FDA Voice is a new forum for us. Although I am writing the first blog post, in the future you will see posts from a wide range of FDA officials and staff, including scientists and public health professionals, employed at headquarters here in the Washington DC area, across the United States, and in posts abroad in countries as far away as China and India.

Through FDA Voice, we hope to give you insights on some of the most pressing public health issues of the day. For example, how does globalization affect the food that we eat? How is the pace of innovation affecting the availability of new medical treatments for you and your family? What does personalized medicine mean for me? And even, what is the latest on food safety for my pet?

I believe that providing a forum like this is especially important for an agency like FDA, where the products that we regulate are directly related to public health and the issues that we work on tend to be complex in nature. FDA Voice will give FDA employees the opportunity to go beneath the surface to tell you about what they are working on and how it impacts your life.

No matter which stakeholder group you consider yourself a member of – consumer, patient, medical professional, scientist, researcher, or industry – it is our hope that you will find this medium an unparalleled opportunity to get more details directly from the source, like details of an official trip, activities in the lab, or more background information about a policy issue or regulation.

You will find FDA Voice on our homepage – and you may notice some additional changes there today as well. We have given the homepage a cleaner look and feel – by updating the design and reducing the number of links on the page. We have been working hard to improve your experience at FDA.gov, and hope that the changes we have made will help you find the information you need as quickly and easily as possible.

As Americans living in the Information Age, we are always looking for new and better ways to communicate. I am glad that you decided to take time out of your day to stop by and read FDA Voice, and I hope you will make it part of your routine in the future.

On behalf of all of the employees at FDA, I wish you and your loved ones a very happy holiday season.

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