Track Our Success as We Implement New Law

Posted on May 15, 2013 by FDA Voice

By: Leslie Kux and Malcolm Bertoni

As we continue to implement the exciting new tools provided by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), we are inviting interested members of the public to use the Internet to track our progress.

Leslie Kux

FDASIA gave FDA new authorities to help FDA establish improved systems for combating drug shortages, protect the drug supply chain in an increasingly global market, and get generic medicines on pharmacy shelves and available to consumers more quickly. It is also encouraging companies to invest in discovering and developing new antibiotics, accelerate patient access to new medical treatments and breakthrough therapies, and promote the development of more treatments for children.

To track FDASIA’s progress, we leveraged an existing FDA web page that publishes pertinent information about a wide variety of FDA initiatives, and we added what we think are even better web tools for searching for specific details about a particular action.

The site currently shows that more than 30 of the tasks aimed at improving public health are completed. The site also lists numerous other steps involved in implementing the law and in each case provides a targeted completion date for the task and links to more information. Each task listed also includes a contact for more information or how to get answers to questions—either the e-mail address of an individual FDA employee or of an office specifically designated to handle that task.

Weaving the new authorities from the 140-page law into existing programs is a Herculean task, and doing it right takes time. We are committed to get the job done as quickly as possible while still making the best decisions that will serve the nation now and in the future.

Malcolm Bertoni

We established this web page to make that process transparent, and to encourage the input of those involved. Our immediate focus is on those provisions of the law that will have the greatest public health impact for which resources are in place, allowing us to act quickly.

We appreciate that some may be interested in viewing the nitty-gritty detailed listing of the many, complex actions involved in implementing FDASIA, and some may not. But we know the actions themselves will prove important to consumers and patients, who will ultimately benefit from the provisions of this new law.

Consumers and industry can find in-depth information, including fact sheets, news releases and technical information, at the FDASIA web page. FDASIA represents the potential for major improvements, and we are using everything at our disposal, to pursue the important goals it presents.

Leslie Kux is FDA’s Assistant Commissioner for Policy

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

Honoring an FDA Champion of Safe Treatments for Children

Posted on May 6, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

It has been 11 years since Congress passed the Best Pharmaceuticals for Children Act mandating the creation of the Office of Pediatric Therapeutics (OPT) at FDA. But it has been light years in terms of the progress we have made to ensure that children have access to innovative, safe and effective medical products.

Increasingly, parents can rest assured that the medications they give their children have been tested—in children—in scientifically necessary and ethical clinical trials. OPT’s Pediatric Advisory Committee has reviewed over 200 products for their safety when used by children. Today, nearly 500 drug and biologic products have been improved by including, in their labeling, information describing safety, effectiveness and, where appropriate, dosing relating to use of the product in children.

We’ve come a long way. And as director of OPT since 2003, pediatrician Dianne Murphy, M.D., has led the charge.

It is because of her indefatigable work on behalf of children that the American Academy of Pediatrics (AAP) has bestowed on Dr. Murphy its Excellence in Public Service Award (EPSA) “representing the highest honor awarded…to a public servant for distinguished service to the nation’s children, adolescents and young adults.” In the letter informing Dr. Murphy of this honor, AAP says her work at FDA “has profoundly improved the lives of children in the U.S. and around the world through increased access to needed therapeutics.”

I couldn’t agree more.

For many years before Dr. Murphy began her tenure at FDA, the playing field badly needed leveling when it came to safety in children’s drugs. Very few drugs—even those meant solely for children’s use— were actually tested on children. For one thing, some drug companies, eager to get their new products out while they still held exclusivity (that is, the period of time during which generic drugs cannot be developed), were reluctant to take the time or go to the expense. Many people, too, felt it was unethical to use children as so-called “guinea pigs.”

Without the information gained from testing children in clinical trials, health care professionals and parents alike could only guess when trying to gauge the correct dosages for children.

This was an enormous problem. Children are vulnerable. Their organs are developing, and they are experiencing physical changes that affect how a drug is metabolized. As Dr. Murphy has often said, guessing at the dose just doesn’t work. Children must be studied if we are to give them safe and effective treatments.

The sea change began ten years before her arrival at FDA, when AIDS was entering the public consciousness. Dr. Murphy has told me that at the time, she was treating children in her practice who were dying of AIDS because there were no drugs available specifically to address their unique needs.

Based on that hard lesson, a major priority when she came to FDA was to ensure that drugs for children first be tested in children in clinical trials. Dr. Murphy has worked with FDA scientists and reviewers to ensure that pediatric studies are rigorously designed and conducted in accord with current scientific understanding of the characteristics that make children unique. And she has championed FDA’s involvement in the international arena, where FDA has emerged as a leader in regulatory thinking.

In achieving this honor, Dr. Murphy is in very good company. She shares it with such distinguished former honorees as First Lady Michelle Obama, the late Sen. Edward M. Kennedy, Rep. Henry Waxman, former FDA Commissioner David A. Kessler, and National Institutes of Health Director Francis S. Collins.

At FDA, we offer our congratulations, and our thanks.

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

FDA’s Collaboration with Chinese Partners Gets Stronger Each Year

Posted on May 3, 2013 by FDA Voice

By: Mary Lou Valdez

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

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

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

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

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

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

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

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

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

FDA’s Rusty Katz Honored for Research on Alzheimer’s

Posted on April 26, 2013 by FDA Voice

By: Bob Temple, M.D.

Bob Temple, M.D.

Alzheimer’s disease is one of America’s most pressing and rapidly growing public health problems.

Therefore I announce with great pride and respect that one of FDA’s leaders in the field of Alzheimer’s disease research and drug development has been nationally recognized for his contributions to combating this progressive and debilitating disease. I cannot think of a more deserving individual than Dr. Russell Katz, “Rusty” to us, to be so honored.

At its recent National Alzheimer’s Dinner, the Alzheimer’s Association awarded Rusty the Ronald and Nancy Reagan Research Award, which honors researchers who are leading the way in promising and innovative approaches to Alzheimer’s treatment, prevention and care. He joins a distinguished list of past honorees from the Mayo Clinic, University of Virginia, Johns Hopkins University School of Medicine, Harvard Medical School, and many other outstanding organizations.

Dr. Katz first joined FDA in 1983. Today, he is director of FDA’s Division of Neurology Products, the division that reviews and approves drugs for neurological conditions, including those for patients with Alzheimer’s disease.

One in eight older Americans suffers from Alzheimer’s disease (AD), the sixth-leading cause of death in the United States. As Rusty has noted, “The aging of the baby boomers is fueling what could turn a public health problem into a public health crisis.” If no treatments are developed to prevent, cure or slow the progression of AD, the number of Americans suffering from this pernicious disease will grow from 5.4 million to as many as 16 million by 2050, according to estimates by the Alzheimer’s Association.

Dr. Katz has been a critical figure in the advancement of research and drug development for Alzheimer’s disease, building strong partnerships in the Alzheimer’s community and strengthening the science needed to evaluate the safety and effectiveness of potential new drugs.

He has been particularly instrumental in helping drug developers focus on ways to study drugs in the early stages of AD, and when there is hope that disease progression can be stopped or delayed before too much damage is done. With his colleagues he drafted an FDA “guidance” on conducting studies in early stages of AD. It addresses difficult questions, such as these: how do we select patients for clinical trials for early-stage AD drugs despite the fact that early stages of the disease are hard to diagnose? And how can we determine the effectiveness of a drug for early-onset AD when symptoms are difficult to define?

FDA is devoted to seeing new treatments for AD enter the development pipeline. No one has been more instrumental in helping to implement that vision than Dr. Katz. We thank him for his dedication and hard work, and along with the Alzheimer’s Association, applaud him for all that he does to advance public health.

Bob Temple, M.D., is Deputy Director for Clinical Science in FDA’s Center for Drug Evaluation and Research.

FDA Counterfeit Detector to Aid Battle Against Malaria

Posted on April 24, 2013 by FDA Voice

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

Deborah M. Autor

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

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

Melinda K. Plaisier

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

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

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

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

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

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

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

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

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

High-Tech Methods to Monitor High-Tech Devices

Posted on April 23, 2013 by FDA Voice

By: William Maisel, M.D., M.P.H.

Whether they are inserted into the human body to repair organs and joints or used outside the body to test and treat injuries and disease, medical devices in our high-tech world can seem miraculous.

But while they can help the lame to walk, make damaged hearts beat and even, in a recent innovation, help the blind with a rare disease to actually perceive some images and movement, they are not always perfect.

Before most medical devices are allowed on the market, the U.S. Food and Drug Administration works intensively with manufacturers to analyze and review their scientific and technical data on the device. But not everything can be known about a device before it is marketed. That’s why it’s important to have a robust post-market system to collect data on how well medical devices work for patients once they have been marketed. While our current monitoring system is working well, we have proposed updates that rely in part on new technologies to collect better quality and more timely data.

These updates will combine new technologies with a reporting system that expands the engagement of both health professionals and patients in identifying problems, and is intended to more quickly and accurately identify problems as devices are used by a larger number of patients. At the same time, information from our updated system can help new devices get to patients who need them as quickly as possible.

These updates include:

A Unique Device Identification system: As proposed, a unique device identifier (UDI) is an alphanumeric and automatically identifiable code that would have to be assigned to every device model, unless exempt, and appear on their label and package. Once available, the UDI will allow rapid and precise responses to a reported problem while avoiding unnecessary responses. Data from the UDI might be able to pinpoint the source of a safety problem to a specific model, avoiding broader recalls of similar devices and even preventing unnecessary surgeries to remove a device that although similar, may not be the actual source of the problem.
The MedWatcher mobile application (app). This app allows medical device users to easily report suspected or known problems with a device from their smartphone or tablet. Manufacturers and health care facilities will continue to be required to report problems through the Medical Devices Reporting System and the Medical Product Safety Network.
A new planning board, which includes stakeholders outside the FDA, to facilitate the creation of a sustainable, integrated medical device post-market surveillance system; and
Medical device registries for selected medical devices.

All of these updates are tailored to protect the privacy of patients, and they can be accomplished under existing FDA authorities. They were developed in consultation with patient groups, academic experts, health care professionals and device makers.

Rapid technological advances are creating increasingly complex devices. We are determined to keep up, and believe this enhanced system will help us protect patients while making sure they can take advantage of life-saving and life-enhancing devices.

William H. Maisel, M.D., M.P.H., is Deputy Director for Science and Chief Scientist at FDA’s Center for Devices and Radiological Health

Help FDA Help Patients Have a Bigger Voice

Posted on April 23, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

Get Informed. Get Involved. Help FDA Help Patients Have a Bigger Voice. That’s the slogan of a new FDA web site that I’m excited to announce today. The FDA Patient Network has been designed from the ground up to focus entirely on patients.

FDA has long been developing ways to increase patients’ interest and participation in the agency’s work, and in the policies and decisions that affect them.

Since the early 1990s, FDA has been working directly with patients and patient advocates to help them learn more about how medical products are developed and regulated. Patient representatives participate in FDA advisory meetings, and contribute the important perspective of their patient community. When patients better understand the intricacies of how medical products are studied, reviewed, assessed and brought to market, their input will be that much more focused and valuable. We hope, with the launch of this new web site, to expand the role of patients beyond the select group of patient representatives and to engage a wider audience of patients in new and broader ways.

The FDA Patient Network web site is an interactive tool for educating patients, patient advocates, and consumers on how their medications – both prescription and over-the-counter –and medical devices move from the realm of idea to the realm of the marketplace. It brings together, in one place, information that is important to patients, making it easier for them to find what they are looking for and to understand the significance of their findings.

This web site will open new channels of communication with the public, such as live chats with senior agency officials. It will help patients and consumers better understand the process for determining whether medical products are safe and effective and encourage them to contribute their ideas and concerns about the development and regulation of these products.

I am excited because this new Patient Network web site provides a new model for FDA to follow in making its inner workings transparent to the public. It ushers in a new era of access and input for patients and consumers that will evolve with the needs of both communities. I encourage you to explore the new site at PatientNetwork.FDA.gov.

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

Watch this video to learn more about FDA’s Patient Network initiative:

The Science of Abuse-Deterrence – Progress Toward Creating Safer Opioids

Posted on April 16, 2013 by FDA Voice

By: Douglas C. Throckmorton, M.D.

Since the 1990’s, extended-release and high-potency opioids have been on the U.S. market, providing a new option to help the treatment of pain. Unfortunately, while these pain relievers often have provided tremendous relief for many, their abuse has reached epidemic levels in the U.S., with devastating consequences to families and patients.

Over the years, FDA has worked diligently with many partners to address this crisis, while also working to ensure that patients in pain have appropriate access to opioid pain relievers.

One important step towards the goal of creating safer opioids, and one that is a high public health priority for FDA, is to encourage the development of formulations of these drugs that deter their abuse.

Today we’ve announced two actions that signal progress in the battle against the abuse of opioid drugs. First, we approved updated labeling for Purdue Pharma’s reformulated version of OxyContin extended-release (ER) tablets. The new labeling describes the product’s abuse-deterrent properties. These physical and chemical properties make it more difficult to crush, break, or dissolve the tablets. These properties are expected to make abuse by injection difficult and to reduce abuse by snorting. This is the first time we have approved such language in opioid drug labeling, and we made this determination after carefully reviewing the available science.

Our other action today was determining that the original formulation of OxyContin ER, which Purdue Pharma stopped shipping in August 2010, was removed from the market for reasons of safety or effectiveness. This finding is important because it means that FDA will not accept or approve any generic forms of the original OxyContin ER.

In making these decisions, FDA was focused on the relatively-new science of abuse deterrence in which the analytical, clinical, and statistical methods for evaluating these technologies are rapidly evolving. Our decision was grounded in the best available science. To guide drug development in this new field, FDA also issued a draft guidance for industry in January, announcing a flexible, adaptive approach to encourage the development of abuse-deterrent opioids. We believe such products have promise to help reduce prescription drug abuse and improve public health.

In the guidance, we describe four categories of abuse deterrence studies and lay out the kinds of labeling language we would consider approving, depending on the scientific data available. And because the science of abuse deterrence is evolving, we’re encouraging feedback and further development in this area, to help speed progress.

Moving forward, FDA will review every application on its own merits, based on applicable scientific and legal standards, and encourage an ongoing dialogue with manufacturers as they consider developing abuse deterrent opioid analgesic products. In addition to scientific rigor, flexibility is essential to encourage innovation, and, in essence, we’ll let manufacturers know where we want them to go, but not prescribe how exactly to get there. Our general goal, overall, is to encourage development of abuse-deterrent opioid products.

Today’s actions are significant components in a much larger effort to address prescription opioid abuse. We will continue to engage with the many groups active in this area – advocacy organizations, patients and family members, Congress, healthcare providers, and other federal government partners. Reducing the tragic toll of opioid abuse in the U.S. depends on this vital collaboration.

Douglas C. Throckmorton, M.D., is FDA’s Deputy Director for Regulatory Programs in the Center for Drug Evaluation and Research.

Keeping Up With Mobile App Innovations

Posted on March 21, 2013 by FDA Voice

By: Christy Foreman

A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he or she is having a heart attack—is in my opinion an extremely smart phone. That is just one example of how mobile medical applications are transforming health care.

As we testified today before Congress, FDA has no intention of stifling innovation in this exciting and rapidly growing field. The fact is, only a fraction of mobile apps would require FDA review. However, when a mobile app is doing the job of a medical device that requires FDA clearance or approval, it’s only logical that both should be governed by the same rules. These are the small percentage of mobile apps that pose a risk of serious illness or death to patients. With these considerations in mind, FDA in coming weeks will be issuing a final guidance document that will help companies determine whether their product will require FDA clearance or approval.

They would be limited to mobile apps that meet the definition of device and are intended for use:

to transform a mobile device into a medical device already regulated by FDA
as an accessory to a medical device already regulated by FDA

In addition to the smart phone that performs an ECG, other examples include a mobile medical app that controls the delivery of insulin; another that acts as a stethoscope; a mobile medical app that takes patient-specific information and provides a clinician with radiation dosage calculations, and mobile medical apps that allow doctors to view X-rays or other imaging on smart phones and tablets.

These examples show why FDA has a public health concern about the potential consequences of a malfunctioning mobile medical app.

FDA’s Center for Devices and Radiological Health has been reviewing mobile medical apps for more than 10 years and in that period we have reviewed about 100 applications and each review has taken about 60 days to complete. We’re confident that the center has the expertise to continue the timely review of the small number of submissions we expect to receive from mobile app developers.

Our final guidance will be informed by some 130 public comments, most of which were overwhelmingly supportive of our risk-based, narrowly-focused approach proposed in the draft guidance. Once the guidance is released, we are confident that the public will see that it represents a careful balance between the need to encourage innovative technology with our mission of providing reasonable assurance that medical products are safe and effective.

Christy L. Foreman is Director, Office of Device Evaluation, at FDA’s Center for Devices and Radiological Health

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

Posted on March 20, 2013 by FDA Voice

By: Margaret A. Hamburg, M.D.

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

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

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

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

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

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

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

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

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

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

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

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

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