Have a Problem? Contact the New Ombudsman in the Office of Regulatory Affairs

By: Melinda K. Plaisier

Melinda PlaisierWhether we are inspecting your facilities, sampling your products, or conducting investigations, the primary goal of FDA’s Office of Regulatory Affairs (ORA) is to protect the public. But I understand the impact our actions can have on you, so I am committed to making ORA’s processes as transparent as possible and quickly addressing problems you may encounter.

That’s why I’m happy to announce a new resource: an ORA ombudsman who can help you with unresolved concerns. While you may continue to bring issues to my staff, Ombudsman Jessica Zeller is dedicated solely to helping you with assessing and resolving problems.

Jessica, who has worked in both industry and government, understands that FDA’s perspective is often different from that of industry and other stakeholders. Her experience makes her an ideal candidate to carry out two primary objectives:

  • To informally and in an unbiased manner, find solutions, when possible, to problems that arise with our external partners, including industry, other governmental agencies, and consumers.
  • To improve communications between ORA employees and stakeholders through outreach and education, helping both sides become more aware of each other’s needs.

“Understanding the pressures that each side faces are critical to working out solutions and allaying fears,” says Jessica. “I intend to hear what you are saying and feel what you are feeling. I will not always be able to get you what you want, but I promise you will have an opportunity to share your concerns, and I will attempt to achieve the best solution possible.”

Although Jessica reports directly to me, and ORA leaders will continue to make final decisions, Jessica is an unbiased third party who will consider and work on your concerns. You may contact her by phone or email, and she will keep conversations as confidential as possible within the limits of the law.

Jessica gained her expert knowledge from more than a decade of work in FDA regulation. During her eight-year tenure at FDA, from 2004 to 2013, she served in the Office of the Chief Counsel and as deputy director of the Office of Compliance and Enforcement in the Center for Tobacco Products. From 2013 until she returned to FDA late last year, Jessica was in-house counsel for Proctor & Gamble. She also previously worked as a congressional staffer, earned a law degree and a master’s degree in bioethics from the University of Virginia, and a bachelor’s degree in biology.

The International Ombudsman Institute defines an ombudsman as a person of prestige and influence who operates with objectivity, competence, efficiency, and fairness. We are proud that Jessica fits that lofty definition so well. I encourage you to reach out to her when issues remain unresolved.

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

Launching a New Natural History Grants Program: Building a Solid Foundation for Rare Disease Treatments

By: Katherine Needleman, Ph.D. and Gumei Liu, M.D., Ph.D.

Today, on Rare Disease Day 2016, FDA’s Office of Special Medical Programs/Office of Orphan Products Development (OOPD) is proud to announce the launch of a new grants program to fund natural history studies with the hope of bringing new and important diagnostics and therapeutics to patients with rare diseases.

Kathy Needleman

Katherine Needleman, Ph.D., is the Director of the Orphan Products Grants Program of FDA’s Office of Orphan Products Development

A rare disease, by definition, affects fewer than 200,000 individuals in the United States. Its impact, however, is far from rare. Altogether, about 7,000 known rare diseases affect about 30 million Americans. Yet the vast majority of rare diseases do not have adequate diagnostic tools or treatments.

Developing such diagnostics or treatments — whether it’s a drug, biologic, or medical device — has been compared by many to building a house. Both require a solid, sound foundation. For any rare disease treatment development program, that foundation consists of having a thorough understanding of the natural history of a disease.

How do you define the natural history of a disease? Think about it as the course a disease takes – from the time of its onset, progressing through its pre-symptomatic phase and clinical stages, to the end of the disease. Insight into a disease’s natural history can help lead to better, more well-designed trials that can accelerate the development of life-saving diagnostics and therapeutics.

Gumei Liu

Gumei Liu, M.D., Ph.D. is a reviewer and grant project officer in FDA’s Office of Orphan Products Development

A lack of understanding of the natural history is often a major obstacle to developing life-saving products for patients with rare diseases. Without it, it becomes very difficult to decide what to study, know what to look for within a study, and capture the data necessary for approval of a treatment or even a cure.

OOPD’s new Natural History Grant Program is intended to provide much needed support and complement ongoing efforts to help change the trajectory of rare disease product development. The funded studies should help characterize the natural history of a rare disease or condition, identify genotypic and phenotypic subpopulations, and develop and/or validate clinical outcome measures, biomarkers, and companion diagnostics.

There are several ways to conduct natural history studies. They can look back in time (retrospective), look ahead (prospective), or be a survey study (collection of data through questionnaires). Each has its pros and cons and the method will to a great extent depend on what we know about a specific rare disease and the currently available treatment options.

Patient advocacy groups can and do play a critical role in collecting natural history data as is highlighted in FDA’s video discussion (watch video below) on natural history studies featuring perspectives from patient advocates. Often what prevents organizations, like patient advocacy groups, from conducting natural history studies is funding. And that’s where the grants program can make a difference.

The Orphan Products Natural History Grants Program is open to funding all types of natural history studies that are appropriate for the rare disease being studied and can aid in development of diagnostics and treatments. There are two funding levels and durations that will be offered:

  • A maximum of $400,000 in total costs per year for up to five years for prospective natural history studies involving clinical examination of affected individuals; and
  • A maximum of $150,000 in total costs per year for up to two years for retrospective natural history studies or survey studies.

The Orphan Products Natural History Grants Program is built upon OOPD’s Orphan Products Grants program that was established by the Orphan Drug Act more than 30 years ago and which has typically funded clinical trials. OOPD has successfully utilized its budget to help bring over 50 products to market with that clinical trial grant program.

We hope that this new Orphan Products Natural History Grants Program will help build the important foundation necessary to accelerate the development of life-saving diagnostic and treatments for the many rare disease patients who need them.

Katherine Needleman, Ph.D., is the Director of the Orphan Products Grants Program of FDA’s Office of Orphan Products Development

Gumei Liu, M.D., Ph.D. is a reviewer and grant project officer in FDA’s Office of Orphan Products Development

Strengthening our Regulatory Relationships in India

By: Mathew T. Thomas and Dean Rugnetta

India’s economic expansion is in part due to the tremendous growth in the pharmaceutical industry. The United States is a large consumer of medical products, and India is one of the largest suppliers of its drug products. And our important work together remains an FDA priority.

Investigator Daniel Roberts

Investigator Daniel Roberts (FDA India Office) and an Indian Regulator sharing inspectional approaches for current good manufacturing practices for pharmaceuticals during the workshop in Ahmedabad

We are working with our counterparts in the Indian government to ensure the medical products manufactured there, especially those for export to the U.S., meet FDA’s safety and quality requirements. FDA established an office in India in 2008, in part to promote government-to-government interactions like these and to keep pace with rapid developments and innovations in the pharmaceutical sector.

In November 2015, representatives from FDA’s India Office, our Center for Drug Evaluation and Research (CDER), Office of Regulatory Affairs (ORA), and Office of International Programs (OIP), partnered with the India Government’s Central Drug Standards Control Organization (CDSCO), to share inspectional techniques and guidance for conducting current good manufacturing practices of pharmaceutical facilities.

Carmelo Rosa and Denise DeGiulio

Carmelo Rosa (CDER), Denise DiGiulio (CDER), and an Indian Regulator discuss Quality By Design guidance with the workshop participants in Ahmedabad

Training sessions were provided in two cities (Ahmedabad and Bengaluru) for about 200 Indian regulators representing CDSCO and some of the State drug control agencies. The training was an example of the cooperation by both agencies to increase knowledge and skills, thereby contributing to the health and welfare of citizens in both countries.

The collaboration resulted in representatives from both agencies learning more about the regulatory perspectives of the other – and doing so first-hand. It was clear from the interactions that the Indian inspectors had extensive knowledge of FDA and of the international techniques for conducting inspections. The FDA representatives at the sessions benefited from input regarding the differences between FDA and Indian legislation and regulations. And as new inspectors comprised the majority of attendees, there was the opportunity for learning on both sides.

FDA Workshop Team in India

FDA Workshop Team in Bangaluru. Front Row – Denise DiGiulio (CDER), Carmelo Rosa (CDER), Leslie Ball (Office of International Programs), Mathew Thomas (India Office), Thomas Cosgrove (CDER), Thomas Arista (ORA). Back Row: Shiva Prasad (India Office), Daniel Roberts (India Office), Solomon Yimam (India Office)

Senior officials from the Government of India attended both events and affirmed their goals of ensuring patient safety and of collaborating with FDA to make sure that products from India are safe and meet appropriate quality standards.

FDA and Government of India regulators will continue leveraging knowledge and strengths to ensure patient safety in India and product quality of FDA-regulated pharmaceuticals.

Mathew T. Thomas is the Director of FDA’s India Office in New Delhi, India

Dean Rugnetta is the Deputy Director in FDA’s India Office in New Delhi, India

A Closer Look at Tea and Rice: FDA Brings FSMA Outreach to Japan

By: Camille Brewer, M.S., R.D., and Sema Hashemi, M.S.

Our delegation of FDA experts traveled to Tokyo and Osaka in the first week of February to hold seminars on our new final rules under the FDA Food Safety Modernization Act (FSMA). These rules will require that foods exported to the United States be produced in a manner that provides the same level of public health protection as that required of U.S. food producers.

FSMA outreach delegation and Ambassador Caroline Kennedy

The FSMA outreach delegation met with Ambassador Caroline Kennedy (center). The delegation members (from left) are: Sema Hashemi, Jess Paulson (from the U.S. Department of Agriculture), Jenny Scott, Samir Assar, Bruce Ross, Camille Brewer, Jeffrey Read, and Brian Pendleton.

We were delighted to see first-hand how receptive the Japanese government and industry have been, both in embracing FSMA’s principles and in bringing a more intense focus on preventive controls and supply chain management. Exports of agricultural, as well as fish and fishery products, to the United States are at a record high. The U.S. is Japan’s second highest export market, and key exports include rice, tea, soy products, confectionary and specialty products. The Japanese food industry is keenly interested in increasing exports to the U.S. and representatives expressed a strong commitment to fostering an understanding of and compliance with our food safety regulations. Throughout our visit, we were reminded of the important link between market growth and maintaining a strong reputation for safe exports.

Interest in FSMA is high. Public seminars in Tokyo and Osaka drew nearly 400 and 200 participants, respectively, our largest FSMA international outreach audiences to date. As a reference document for participants, the Japan External Trade Organization (JETRO) prepared a 315-page manual with translations of key FSMA regulations and FDA presentations for each participant.

JETRO, a government-related organization, has facilitated and delivered numerous informational programs for industry on FSMA since the passage of the law. During our outreach meeting, JETRO also delivered a one-hour FSMA overview, which effectively set the stage for more detailed FDA presentations that followed. These proactive efforts achieved a much greater understanding among participants and more productive interactions during our limited time together.

Our meetings with Japanese government colleagues in the Ministry of Agriculture, Forestry, and Fisheries (MAFF), as well as the Ministry of Health, Labour, and Welfare (MHLW), allowed us to take a step back and discuss ways in which the our governments can work collaboratively to promote food safety. It was clear to us that these ministries are very eager to collaborate closely with FDA to help ensure that Japan’s food exports to the U.S. meet FSMA’s high standards of safety for food production. We are looking forward to further discussions with our Japanese colleagues as FSMA implementation continues.

Our delegation received many thoughtful and detailed questions on how FSMA would apply to Japan’s food exports to the U.S., particularly to green tea and rice — as two foods particularly important to Japanese identity and tradition. Indeed, our delegation learned a great deal about the various steps in the production of both commodities. FDA and the Japanese ministries all committed to exchange more detailed information on traditional production methods for these commodities. They represent valuable case studies on how FSMA operates to ensure prevention-based oversight of the entire food supply chain, including those unique to a culture or community.

U.S. Ambassador to Japan Caroline Kennedy graciously set aside some time to discuss FSMA international outreach activities and food safety issues with our delegation. She was very pleased to hear of Japan’s detailed preparations for these FSMA seminars and the goodwill shown to FDA’s delegation. Ambassador Kennedy stressed the importance of the relationship between the United States and Japan in the area of agricultural trade, agreeing that future dialogue on FSMA would only serve to strengthen these close ties.

We leave Japan with many fond memories of the warmth and hospitality provided by our Japanese hosts. They honored us not only with their kindness but also with the meticulous preparation and education on FSMA that we could see had taken place in advance of our arrival. We move forward more confident than ever in Japan’s strong commitment to food safety and to ensuring that foods exported to the United States will be produced under the effective prevention-based systems that FSMA envisions for food supply chains around the world.

Camille Brewer, M.S., R.D., is Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine

Sema Hashemi, M.S., is Director of the Office of Regional and Country Affairs within FDA’s Office of International Programs

FDA Offers Free, Continuing Education Course to Help Health Care Providers Understand ‘Biosimilars’

By: Leah Christl, Ph.D.

You may have heard about a new category of products called “biosimilars.” What are biosimilars and how do they relate to biological products already widely in use?

Leah ChristlBiological products derived from living organisms can treat patients with cancer, chronic kidney disease, rheumatoid arthritis, inflammatory bowel disease, and other serious conditions. Biological products that are “biosimilar” to, or “interchangeable” with, an already-approved FDA biological product (an FDA-licensed reference product) are one way to improve access and increase treatment options at potentially lower cost for our nation’s health care system.

These products are licensed through a new pathway created in the United States in 2009. FDA is well aware that health care professionals–including prescribers, the nurses who will administer them, and the pharmacists who will dispense them–need to understand how these drugs work and how they are intended to be used.

To that end, FDA has developed a free, Continuing Education Course for health care professionals – titled, FDA Overview of Biosimilar Products – to help them strengthen their knowledge and understanding of biosimilars and interchangeable products. Biosimilars and interchangeable products, for instance, are not generic products, and this education course will help health care professionals fully appreciate the distinction.

There’s a growing interest in biosimilars and interchangeable products in the pharmaceutical industry. The first biosimilar in the U.S. was approved in 2015. It boosts the production of white blood cells and helps to ward off infection in patients receiving strong chemotherapy for some tumors. FDA is reviewing several other marketing applications for proposed biosimilar products.

This course also will help health care professionals understand how a biosimilar can be prescribed and dispensed, and how and when an interchangeable product can be substituted for another biological product.

The program will inform healthcare professionals about the development process and approval pathway for biosimilars and interchangeable products. It also includes information about FDA’s general review process for these products that will help attendees gain a better understanding of the relationships between biosimilars and interchangeable products.

The course is available to health professionals on FDA’s CDERLearn Website, and can be completed on a tablet for those on the go and not at their desktop computer.

Leah Christl, Ph.D., is the Associate Director for Therapeutic Biologics in the Office of New Drugs, at the Center for Drug Evaluation and Research at FDA

CBER’s Laboratory Quality System Management Helps Keep Biological Product Standards High

By: Peter Marks, M.D., Ph.D.

Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the Center as the preeminent regulatory organization for biologics. One way CBER is achieving this: Through the work of the Office of Compliance and Biologics Quality (OCBQ) and the Office of Vaccines Research and Review (OVRR).

Peter MarksThese offices play a major role in helping to ensure the safety and quality of products regulated by CBER. Their work shows that CBER isn’t just talking the talk about its vision, it’s also walking the walk to demonstrate the expertise needed to fulfill that vision.

That walk leads directly to OCBQ’s Division of Biological Standards and Quality Control (DBSQC), OVRR’s Laboratory of Immunobiochemistry (LIB), and the Center’s Laboratory Quality System (LQS) Program.

LQS is the coordinated structure, procedures, processes, and resources that the Center uses to evaluate and test CBER-regulated biological products. LQS product testing supports biological product licensing, Lot release and surveillance of licensed biological products, and other Center actions. The LQS program also is critical to the development and evaluation of reference materials, standards, and manufacturers’ assays. This extensive responsibility makes LQS an important link in the chain of regulatory actions that support CBER’s mission to help ensure the safety, purity, and potency of biological products.

CBER is authorized by law to create regulations that authorize OCBQ and OVRR to oversee facilities that manufacture CBER-regulated biological products and the biological products they make. CBER leaders wanted to go further in demonstrating the Center’s commitment to quality systems, and decided to voluntarily submit the LQS program to accreditation by an unbiased, non-governmental, nonprofit third party: the International Organization for Standardization (ISO).

ISO sets laboratory accreditation standards for academic and industrial organizations worldwide. Laboratories that receive ISO accreditation can rightly state their test results are precise and reproducible. OCBQ and OVRR accepted the challenge to ensure that their work meets high, internationally recognized standards.

The particular standards CBER sought to meet, called ISO/IEC 17025:2005, are used by testing and calibration laboratories. In the United States, industry laboratories can get accredited to ISO standards by one of many accrediting bodies. CBER turned to the American Association for Laboratory Accreditation (A2LA).

In 2010, CBER received accreditation from A2LA for six methods to test influenza vaccines, including those for sterility and potency, and seven methods for evaluating blood donor screening kits that detect the presence of HIV, HBV, HCV, HTLV-I/II, Trypanosoma cruzi, and West Nile virus.

Additional methods have been accredited since then. CBER’s recent accreditation renewal in October 2015, demonstrated the Center’s competence in 32 test methods previously accredited and added a new laboratory test: evaluating a cELISA allergen test used by CBER for cat hair, ragweed, and dust mites in the newly accredited Laboratory of Immunobiochemistry.

These laboratory accreditations signify that this program is an international leader in biological product regulation based on demonstrated expertise in these laboratory techniques. And they offer more evidence that CBER’s goal of being a preeminent regulatory organization isn’t just a vision, it’s a reality that CBER and FDA, can be proud of.

Peter Marks, M.D., Ph.D., is Director of FDA’s Center for Biologics Evaluation and Research

What is FDA Doing to Improve the Health of African-Americans?

By: Jovonni Spinner, M.P.H., C.H.E.S.

Every February, we celebrate Black History Month – a time to reflect, celebrate, and honor the contributions of African-Americans to our society. We know that achieving and maintaining good health is a long-standing issue for this group, many of whom may experience worse health outcomes in critical areas like heart disease and diabetes. But, we want to focus on the positive and provide consumers with health education materials to support healthy behavior changes!

Jovonni SpinnerIt’s true that the health equity gap has narrowed over time, but there is still significant room for improvement. Here are few things that the FDA and the Office of Minority Health (OMH) have done over the past year to reduce health disparities.

Public Engagement: More than 29.2 million blacks/African-Americans are on social media — and we want to meet consumers where they are. So we’re using Facebook, Twitter, and other social media platforms and electronic communications (e.g. our newsletter and e-blasts) to educate African- Americans on issues such as heart disease, diabetes, and sickle cell disease among others, and also provide tangible solutions to help manage these chronic conditions.

For example, to mark American Heart Month in February, we developed a social media toolkit to help our stakeholders engage with their members and partnered with the Association of Black Cardiologists to spearhead an #ILoveMyHeart social media campaign.

Stakeholder Engagement: We have cultivated relationships with a core set of partners to better understand their health needs, aligned our priorities to meet those needs, and worked together to leverage each other’s resources for the common good. By doing so, we’ve increased our stakeholder’s capacity to communicate with the agency on regulatory issues. For example, multicultural stakeholders are now better able to make their voice heard in FDA-sponsored public meetings and on open dockets.

Minority Health Research: We worked with academia to fund African-American-based research projects (e.g. HIV/AIDs and triple negative breast cancer) and research fellows working on topics like genomics and digital communications. This allows us to increase the knowledge base on these issues and ensure a diverse workforce is in place to solve these complex health problems.

Resources: We have taken care to tailor our health education resources, such as infographics and fact sheets, to African Americans. Our website has valuable information on sickle cell disease and lupus, both of which affect African Americans more than any other racial/ethnic group.

Clinical Trial Diversity: Did you know that sometimes minority populations may respond differently to medical products? One example is an FDA-approved heart failure medication that reduces the risk of death and hospitalization in people with certain types of long-lasting/chronic heart failure.

During clinical trials, it was found there was an increased risk of an allergic reaction called angioedema in blacks. In this trial, only 5% of the participants were black, even though blacks represent 13% of the U.S. population and experience heart failure at rates higher than the rest of the population. This is why we continue to work toward increasing clinical trial diversity, to ensure that medical products are safe and effective for everyone!

President Obama has said, “If you’re walking down the right path and you’re willing to keep walking, eventually you’ll make progress.” OMH will continue walking down the path to improving health equity and we want you to join us, because this work cannot be done alone.

Visit FDA’s OMH at: www.fda.gov/minorityhealth

Follow us on Twitter @FDAOMH

Jovonni R. Spinner, M.P.H., C.H.E.S., is a Public Health Advisor in FDA’s Office of Minority Health

Clarifying What We Mean When We Talk About Biomarkers: An NIH/FDA Joint Leadership Council Success

By: Melissa A. Robb, B.S.N., M.S. (RegSci), and Robert M. Califf, M.D.

What if there was a more uniform way to convey key technical terms to help advance scientific progress? Thanks to the Biomarkers, Endpoints, and other Tools (BEST) Resource, we’re one step closer to that goal.

Melissa Robb

Melissa A. Robb, B.S.N., M.S. (RegSci), FDA’s Associate Director for Regulatory Affairs, Office of Medical Policy, Center for Drug Evaluation and Research

Now available on the National Center for Biotechnology Information’s Bookshelf, the BEST Resource was developed through a collaboration of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). It includes a glossary of terms and definitions that will ensure the consistency and clarity needed to drive progress in biomedical research and clinical care.

Why is this textbook so important? In the spring of 2015, the FDA-NIH Joint Leadership Council identified a problem: Confusion about the definitions and inconsistent use of key terms–including biomarkers, surrogates, and clinical outcome assessments. This can deter progress in developing medical products and thereby potentially compromise efficiency in achieving public health benefits.

Accordingly, the council identified a high priority: harmonizing terms—or making sure that everyone is “speaking the same language”–that describe and categorize types of endpoints.

Members from multiple FDA Centers and NIH institutes formed a working group to focus on creating a glossary. This was the first step to a publicly available and open access textbook that could be continuously updated and expanded.

Robert M. Califf, MD, MACC; Commissioner, U.S. Food and Drug Administration

Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug Administration

As the basis of their work, the group considered existing terminology and definitions. Those include FDA guidance documents and other literature, especially a seminal FDA-sponsored Institute of Medicine study.

The use of biomarkers has recently expanded widely to include fields such as mechanistic biomedical research, clinical trials, drug discovery, medical product development, clinical care, and regulatory science. Recognizing this broad influence and the accepted vernacular of these varied fields, the group sought to first reach consensus around biomarker taxonomy.

For example, there’s misunderstanding about the various types of biomarkers and the distinction between biomarkers and surrogate endpoints. One challenge was to settle upon definitions that were broad enough to be used by diverse communities, including biomedical scientists, translational researchers, clinical researchers, medical product developers, and clinicians, and also across diverse types of products.

Where possible, to provide more context and insight into important terms, examples are given alongside many definitions in the BEST Resource. NIH and FDA intend to use the definitions included in this glossary when communicating on topics related to its contents (e.g., biomarkers) to ensure a consistent use of the terms and therefore, a common understanding of the issues. FDA’s Biomarker Working Group, with representation from all of our Centers, contributed to developing these definitions.

Now we need your help. We need your feedback and comments on the glossary. You can provide them at the BEST (Biomarkers, EndpointS, and other Tools) Resource.

In the meantime, we’ll continue to work on adding context to terms related to regulatory science, clinical trials, and laboratory science.

Effective, unambiguous communication is essential for efficient translation of promising scientific discoveries into approved medical products. Once we are all speaking the same language, we can tackle other challenges to bring the promises of biomedical research and clinical care to fruition.

The FDA-NIH Biomarker Working Group members include: from FDA – Shashi Amur, Robert L. Becker, Robert Califf, Aloka G. Chakravarty, David S. Cho, Nina L. Hunter, Ilan Irony, Christopher Leptak, Kathryn M. O’Callaghan, Michael A. Pacanowski, Elektra J. Papadopoulos, Vasum Peiris, Melissa Robb, Hobart L. Rogers, Rachel E. Sherman, Robert J. Temple, Ann Marie Trentacosti, and Sue Jane Wang; and from the NIH – Holli Hamilton, Pamela McInnes, Lisa M. McShane, and Monica R. Shah.

Melissa A. Robb, B.S.N., M.S. (RegSci), is FDA’s Associate Director for Regulatory Affairs, Office of Medical Policy, Center for Drug Evaluation and Research

Robert M. Califf, M.D., previously FDA’s Deputy Commissioner for Medical Products and Tobacco, became FDA’s Commissioner of Food and Drugs on Feb. 25, 2016

Building a Case for Medical Device Interoperability: FDA’s Call to Action

By: Bakul Patel, M.S., M.B.A.

As Yoda might say: build a case for interoperability, we must. While we may not have yet realized the technological accomplishments of Yoda’s advanced world, today connectivity shows great promise for the future.

From blood pressure to brain scans, today’s health care allows for the rapid transfer and use of information between and among different medical devices. This concept—called interoperability—is less about basic communication and more about the smart and safe interaction among medical devices and information systems.

Seamless interoperability among medical devices can improve patient care, reduce errors and adverse events, and lower costs. In fact, interoperability is one of the key factors for safety that can drive innovation in care delivery.

Think of a scenario in which devices collect a patient’s vitals during surgery. Then think about staff having to manually enter those vitals into a health care record because the format of the data generated by operating room devices isn’t compatible with the format necessary for the health care record, which by the way, only operates in one format. In this situation, the lack of interoperability can lead to errors during the manual entry process, and possible inefficiencies in patient care.

Now think about another scenario in which a patient is connected to a ventilator that can alert a caregiver—or automatically adjust its function—by monitoring an oximeter that measures blood’s oxygen saturation levels. In this situation, the interoperability between the ventilator and oximeter better coordinates their interaction and may reduce nuisance alarms, allowing clinicians to focus on true clinically significant alarms.

FDA has been collaborating with hospitals, health care providers, manufacturers, standards-development organizations, and other interested parties to promote medical device interoperability because it helps patients.

Some key activities in pursuit of this goal include the following:

In addition, we recently released draft guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, which outlines our ideas on design considerations for manufacturers developing interoperable devices. It contains our recommendations for information manufacturers should include in their pre-market submissions and ultimate product labeling. It also encourages manufacturers to make all necessary and relevant functional, performance, and interface characteristics openly available, enabling users to safely use medical devices with other devices or systems.

This draft guidance is intended to promote and facilitate development of safe and effective interoperable devices, thereby strengthening the much needed “case” for interoperable medical devices. We intend to work with stakeholders toward a future where interoperable devices increase care efficiency and reduce care costs, while keeping patient safety in the forefront.

We’re encouraging all stakeholders to share comments on this draft guidance with us.

We believe now is the time for all stakeholders—including medical device manufacturers, health care organizations, researchers, and information systems firms—to come together and continue to build this case to accelerate the development and availability of safe interoperable medical devices.

In Yoda’s words…may the force of interoperability be with us!

Bakul Patel, M.S., M.B.A., is associate director for digital health in FDA’s Center for Devices and Radiological Health

Using Social Media to Teach Consumers About Heart Health

By: Jonca Bull, M.D.

Jonca BullFebruary is American Heart Month. Heart disease remains a significant problem in the United States – it’s the leading cause of death, disproportionately affecting minorities. In particular, minorities have higher rates of hypertension, diabetes, and smoking, which are risk factors that can cause heart disease. This month, we’ll be working with the Centers for Disease Control and Prevention and the National Institutes of Health to help raise awareness.

Our social media platforms will be key to engaging the multicultural population. And they have a proven reach: 65% of Hispanics and 56% of African Americans use social media. In 2014, on average 40% of all cell phone owners used a social media site, with blacks and Hispanics leading the trend at 48% and 49%, respectively.

So, how will FDA’s Office of Minority Health use social media to reach key populations? Here are just a few things we have in store for February:

  • Sharing culturally relevant messages for Twitter and Facebook. We want to stimulate dialogue on two key areas: (1) knowing your risk factors and (2) using our resources to help manage them. This month, our outreach will provide information and resources on the following:
    • Heart Disease: Who does it affect and what are the risk factors?
    • Smoking: Smoking is a risk factor for developing heart disease. FDA has resources to help you quit.
    • Healthy Eating and Living: FDA has materials to help consumers make heart healthy decisions (e.g. how to read the food label), manage their risk factors through FDA-approved medications, and tips for preparing healthy meals.
  • Working with stakeholders to use social media as an engagement tool. We have developed a social media toolkit to guide stakeholders in communicating with their members. The toolkit will contain drafted social media messages, infographics, and links for consumers on heart disease and risk factor management. Email omh@fda.hhs.gov to receive the toolkit.
  • Hosting a bilingual Twitter chat with our partner, @SaludToday on Tuesday, Feb. 16th from 1 p.m. – 2 p.m., EST. We’ll chat about risk factors for heart disease and provide tips to lead a heart healthy lifestyle. We hope you can join us and provide your insights on this important topic.
  • Spearheading an #ILoveMyHeart social media campaign with our partners @SaludToday and @ABCardio1 asking you to show us how much you love your heart! Participants will upload pictures with the #ILoveMyHeart hashtag describing their heart healthy activities. Be sure to post your picture and tag @FDAOMH!

We know that social media is becoming a valuable health education tool to reach minorities. And, we will continue to use it to engage with our audience. Please follow us and share heart-healthy messages all month.

For more information about FDA’s OMH visit us at: www.fda.gov/minorityhealth

Follow us on Twitter @FDAOMH

Jonca Bull, M.D., is FDA’s Assistant Commissioner for Minority Health