Learning from the Oneida: Food and Fellowship at the Heart of a Community

By: Michael R. Taylor

All over the country, local food systems produce, market, and distribute foods that nourish their communities. In our travels over the past few years, seeking input on proposed rules to implement the FDA Food Safety Modernization Act (FSMA), we have seen first-hand just how important these grassroots systems are to the American way of life.

Oneida Food Distribution Warehouse in Oneida, Wisconsin

Warehouse Supervisor Leonard Stevens with Deputy FDA Commissioner Michael Taylor at the Oneida Food Distribution Warehouse in Oneida, Wis. The Oneida Food Distribution Program feeds low-income members of the community.

I saw another impressive example of a community-centered food system when my colleagues and I toured the Oneida Nation in Wisconsin last month and met with members of the tribe, who are justifiably proud of their farming traditions. We met the people behind the Oneida Community Integrated Food Systems (OCIFS), established in 1994, which provides education about food, nutrition and health, and integrates locally produced foods into the Oneida community and institutions.

It is an impressive system. It includes a 6,000 acre farm, where they raise Black Angus cattle and bison; a 40-acre apple orchard that offers 34 varieties of apples, as well as other fruits and vegetables; an 80-acre organic farm that has community gardens and a cannery, and offers workshops on cooking and gardening; a food distribution program that feeds low-income members of the community; and a market in which the Oneida sell what they have planted, produced and harvested.

The community produces more than food. It also encourages healthy-eating. There is a state-of-the-art health center that focuses on weight management and diabetes prevention, striving to empower members of the community to make positive life choices. The facility is evocative of the tribal culture and sophisticated in its delivery of health services. They have had incredible success in improving diabetes outcomes in terms of care and prevention.

We toured and met with tribal leaders. Then we had a frank discussion about the important relationship between the FDA and the more than 560 federally recognized American Indian and Alaska Native tribes and villages. The Oneida Nation is a sovereign state, as are the other tribes, and federal agencies have an obligation to consult them in certain matters of importance. From their standpoint, the sheer number of federal agencies they have to deal with—including FDA, the U.S. Department of Agriculture, the Environmental Protection Agency, and the U.S. Fish and Wildlife Service—can be a source of frustration and confusion.

From FDA’s perspective, the challenge of working effectively with hundreds of diverse, sovereign tribal governments mirrors the challenges we face across the breadth of FSMA implementation.

The Oneida Nation is emblematic of the diversity of our food system. This diversity is a great strength, but it’s also part of what makes implementing FSMA and achieving food safety a daunting task. It’s doable, however, because, whether they’re sending their products around the world or around the corner, all participants in today’s food system have the same stake in food safety. It is FDA’s mission to reach across this broad spectrum, create standards that are feasible for all food producers, and support their food safety efforts any way we can.

This demands collaboration and partnerships. Our partnership with American Indian and Alaska Native tribes is among the building blocks of the modern food safety system mandated by FSMA. I was inspired by what I saw in our trip to the Oneida Nation, by their cultural commitment to the health of their community and their willingness to embrace new technologies while staying true to traditions. They lend rich color to the kaleidoscope that is our global food system.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

FSMA: The Future Is Now – Stakeholder Perspectives

On April 23-24, 2015, FDA hosted the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The national public meeting in Washington, D.C., continued on the second day with a panel discussion on stakeholder perspectives.

Participants: Sandra Eskin, J.D., Director, Food Safety, The Pew Charitable Trust; Leon Bruner, D.V.M., Ph.D., Executive Vice President for Scientific and Regulatory Affairs and Chief Science Officer, Grocery Manufacturers Association; Marsha Echols, J.D., Legal Advisor, Specialty Food Association; Richard Sellers, Senior Vice President of Legislative and Regulatory Affairs, American Feed Industry Association; David Gombas, Ph.D., Senior Vice President of Food Safety and Technology, United Fresh Produce Association; Sophia Kruszewski, J.D., Policy Specialist, National Sustainable Agriculture Coalition; Stephanie Barnes, J.D., Regulatory Counsel, Food Marketing Institute. Moderator: Roberta Wagner, Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition, FDA.

FSMA: The Future Is Now

By: Michael R. Taylor

FDA is holding the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The two-day national public meeting in Washington, D.C., began Thursday, April 23, 2015 with a panel discussion by top FDA leaders on the overarching philosophy and strategy. Participants: Michael Taylor, J.D., Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy; Melinda Plaisier, M.S.W., Associate Commissioner for Regulatory Affairs, Office of Global Regulatory Operations and Policy; Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition; Bernadette Dunham, D.V.M., Ph.D., Director, Center for Veterinary Medicine. Moderator: Kari Barrett, Advisor for Strategic Communications and Public Engagement, FDA

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Congratulations to FDA’s Dr. Richard Pazdur, recipient of the AACR’s prestigious Distinguished Public Service Award

By: Stephen Ostroff, M.D.

In the past five years, FDA’s Center for Drug Evaluation and Research (CDER) has approved more than 40 novel cancer treatments, offering hope to many patients who previously had few or no treatment options. Among these products are new and cutting-edge targeted therapies—sometimes called “precision medicines”—tailored to treat patients based on their individual characteristics.

Acting FDA Commissioner, Stephen Ostroff, M.D.

Acting FDA Commissioner, Stephen Ostroff, M.D.

This achievement is a tribute to the dedicated CDER scientists and clinicians who support innovative development of cancer drugs, and evaluate the safety and effectiveness of new products for FDA approval. They are led by the dynamic and creative thinker, Dr. Richard Pazdur, a 16-year FDA veteran whose name has become synonymous with excellence in cancer drug research, development, evaluation and approval.

It is with great pride and admiration that I share with you today that the American Association for Cancer Research (AACR) has awarded its 2015 Distinguished Public Service Award to Dr. Pazdur. AACR selected Dr. Pazdur for this award based on his “extraordinary, steadfast leadership in scientific and regulatory affairs” and his “unwavering commitment to ensuring the development of safe and effective treatments for cancer patients.” The Association also noted that Dr. Pazdur’s “important work has been and continues to be nothing short of spectacular, and it is saving lives every day from this most feared disease that affects so many.”

Dr. Richard Pazdur (left) receives the 2015 Distinguished Public Service Award from AACR President Dr. Arteaga

Dr. Richard Pazdur (left) receives the 2015 Distinguished Public Service Award from AACR President Dr. Arteaga. Photo by © AACR/Todd Buchanan.

As director of the Office of Hematology and Oncology Products (OHOP) at FDA, Dr. Pazdur leads a staff of more than 150 oncologists, toxicologists, and other specialists dedicated to approving safe and effective drugs for cancer and blood-related conditions. Dr. Pazdur and his staff are committed to facilitating rapid development, review, and action on promising new treatments to combat these diseases and improve patient outcomes. Dr. Pazdur and the OHOP staff are also committed to outreach with the oncology community. In 2005, Dr. Pazdur established the Oncology Program, which coordinates oncology activities within FDA as well as with external stakeholders providing OHOP with a unique infrastructure within CDER to interact with professional societies and patient advocacy groups.

We are grateful for Dr. Pazdur’s sustained contributions and look forward to many more years of his leadership, and his adept and proficient manner in helping patients in need.

Stephen Ostroff, M.D., is Acting Commissioner of the U.S. Food and Drug Administration

FDA’s Keynote Address to the Annual Conference of the Food and Drug Law Institute

By Stephen Ostroff, M.D.

Today marks the start of my third week as Acting Commissioner of FDA and I “celebrated” by giving a keynote address to attendees at the annual conference of the Food and Drug Law Institute (FDLI). Few places offer a more appropriate stage for a newly designated leader of FDA. As our names suggest, our organizations have a lot in common.

Stephen OstroffFor decades, the FDA and FDLI have worked together to educate and inform the broad “food and drug” community about the latest developments in our field and FDA’s critical and complex role in promoting and protecting the public health.

It’s been an exciting, busy, and rewarding first three weeks since moving into my new office from the position of Chief Scientist. The FDLI annual meeting offered me the opportunity to highlight a number of FDA’s accomplishments over the last year. The credit for these achievements in no small measure goes to the immensely talented employees at FDA who are committed to assuring safe and nutritious foods, providing effective and high quality medical products, and reducing harm from tobacco products. Credit for these achievements also reflects the extraordinary leadership of my predecessor, Dr. Peggy Hamburg, over the last 6 years.

So today, I’m pleased and honored to present to this audience some of FDA’s accomplishments and challenges, and also to extend my sincere appreciation to FDA’s dedicated work force, who make my new job much easier. But much more importantly, our work force makes the lives of so many Americans safer and healthier. It is with great pride that I look forward to continuing to work with all of you in support of this noble goal.

Stephen Ostroff, M.D., is Acting Commissioner of the U.S. Food and Drug Administration

FDA and CMS Form Task Force on LDT Quality Requirements

By: Jeffrey Shuren, M.D., J.D. and Patrick H. Conway, MD, MSc

Health care providers and their patients expect that laboratory tests used in clinical management of patients should be consistent and of high quality.

Jeffrey Shuren

Jeff Shuren, M.D., J.D.

Under FDA’s proposed framework for the oversight of laboratory developed tests (LDTs), outlined in draft guidance documents issued in October 2014, FDA would oversee the quality of these laboratory tests, alongside the Centers for Medicare and Medicaid Services (CMS), which regulate the laboratories themselves through the Clinical Laboratory Improvement Amendments (CLIA). We have heard stakeholder confusion about the roles of the two agencies in ensuring quality and concerns about potentially duplicative efforts. To coordinate efforts across the Department, FDA and CMS are establishing an interagency task force that will continue and expand on our collaboration related to the oversight of LDTs, which are tests intended for clinical use and designed, manufactured, and used within a single lab. The task force, comprised of leaders and subject matter experts from each agency, will work to address a range of issues, including those involving quality requirements for LDTs.

Patrick H. Conway, MD, MSc

Patrick H. Conway, MD, MSc

Under the proposed LDT framework, FDA would phase in enforcement of premarket review requirements and the quality system regulation for some LDTs. FDA’s oversight of LDTs will assure that the tests are both analytically valid (able to accurately detect analytes) and clinically valid (able to measure or detect the clinical condition for which the test is intended). FDA is currently reviewing public comments on the draft guidances that it received through an open public docket and a two-day public meeting. In response to public comments, FDA may modify the proposed framework when we issue final guidance.

CMS, under CLIA, oversees the labs’ processes, rather than the tests they develop. CLIA and its implementing regulations include requirements for establishing and maintaining quality laboratory operations and ensuring the lab is staffed by qualified personnel. These laws do not require premarket review of tests or any evidence that a test is clinically valid.

When FDA’s proposed framework is implemented, both FDA and CMS will play a role in ensuring that LDTs are high quality—CMS through CLIA by continuing to focus on laboratory operations including the testing process and FDA by enforcing compliance with the agency’s quality systems regulation pertaining to the design and manufacture of the laboratory tests.

Although the roles of the agencies are different, FDA and CMS share an interest in ensuring effective and efficient oversight of LDTs so laboratories can offer tests to the American public with confidence that they are accurate and provide clinically meaningful information without unnecessary or duplicative agency oversight.

The goals of the FDA/CMS Task Force on LDT Quality Requirements include:

  • identifying areas of similarity between the FDA quality system regulation and requirements under CLIA;
  • working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and
  • leveraging joint resources to avoid duplication and maximize efficiency.

The task force is currently exploring areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories. The task force understands stakeholders’ concerns about differences in terminology used by FDA and CMS. We intend to clarify the terms used so that labs may better understand what is expected of them.

Our new task force is committed to its stakeholders and intends to provide education and outreach, including an upcoming webinar series, to address additional needs that are identified during this collaboration. We welcome any feedback and encourage you to contact us at LDTFramework@fda.hhs.gov.

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

Patrick H. Conway, MD, MSc, is Acting Principal Deputy Administrator CMS Chief Medical Officer

FDA Celebrates 30 Years of Advancing Health Equity

By: Jonca Bull, M.D.

April is Minority Health Month! I am proud to say that FDA’s Office of Minority Health (OMH), in collaboration with  the Department of Health and Human Service’s Office of Minority Health, is celebrating this year’s theme: “30 Years of Advancing Health Equity, The Heckler Report: A Force for Ending Health Disparities in America.” For us at FDA, this year also marks the 5th anniversary of OMH, which serves as the principal advisor to the Commissioner on minority health and health disparities.

Jonca BullThe Heckler Report was a major, ground breaking document that transformed HHS’s views and actions on minority health. For the first time in history, representatives from each agency convened to talk about minority health and, more importantly, put forth recommendations to achieve health equity. Findings illustrated huge disparities between African Americans and other minorities compared to the population at large for key health indicators, such as life expectancy and infant mortality. Key recommendations relevant to FDA’s mission centered around health information and education, cooperative efforts (inside and outside of the government), health professions development, data development, and developing a research agenda.

Let’s stroll down memory lane and recap FDA’s activities that resulted from the Heckler report.

Health Information and Education 

FDA has developed numerous outreach activities to improve consumer education and access to health information by utilizing the best cultural and linguistic practices to reach diverse minority populations. Hosting symposiums and webinars, participating in conferences, exhibiting in health fairs, and creating consumer educational materials are just some of the activities FDA has carried out to raise awareness and educate the public. Most recently, OMH has created a social media presence on Twitter and Pinterest, and maintains an active listserve with a quarterly newsletter. One of our most successful outreach campaigns has been the “Heart Health Toolkit” for American Heart Month, which reached over 6,000 people in February.

Our most recent consumer outreach occurred on March 25th via a webinar on how the public can respond to requests for comments on regulatory proposals and public health issues by using FDA dockets.

Cooperative Efforts/Health Professions Development

OMH embraces the notion that protecting the public’s health cannot be done in isolation. We have focused on four areas to improve stakeholder relations:

  • Work with Industry to increase diversity in clinical trials;
  • Work with minority serving institutions and organizations to implement strategies and programs to improve regulatory science (specific to minorities);
  • Provide platforms for stakeholders to become informed and involved about our work; and,
  • Host and promote mentoring programs to encourage minorities to stay in scientific and academic careers.

Data Development and Research Agenda

We have a robust research agenda that focuses on advancing regulatory science related to eliminating health disparities. The agenda consists of various intramural and extramural grant programs, giving preference to minority-serving institutions. FDA also promotes and funds research that aims to increase the quantity, and improve the quality, of data on minorities, and to make these efforts transparent to the public.

In short: FDA has been and will continue to be committed to narrowing the health disparities gap. OMH will continue our legacy of creating culturally and linguistically tailored tools, materials, and resources for minority communities to increase their awareness and understanding of FDA’s mission and of the products that FDA regulates, increase their participation in clinical trials, and increase diversity in the workforce. This ensures better representation in the workforce, and most importantly: better health for all minorities!

More information about specific programs can be found on our website.

The Heckler Report can be found at: http://collections.nlm.nih.gov/catalog/nlm:nlmuid-8602912-mvset.

Jonca Bull, M.D., is Director of FDA’s Office of Minority Health

Reducing the number of unapproved drugs while working to prevent drug shortages: a job that calls for strong collaboration in FDA

By: CAPT Val Jensen and Cynthia Schnedar

Val Jensen

CAPT Valerie Jensen R.Ph., Associate Director of the Drug Shortage Staff, Center for Drug Evaluation and Research, FDA

Several of FDA’s recent drug approvals highlight how different parts of FDA work together to achieve the same goal: ensuring an adequate supply of FDA-approved drugs for U.S. consumers. Our drug shortages team partners with many groups within the agency to achieve this goal. One of these partnerships is with our unapproved prescription drugs staff.

Patients and doctors alike may be unaware that some prescription drugs are not FDA-approved, because versions of some of these products have been marketed for decades, often with little data to demonstrate whether these drugs are safe and effective. At FDA, one task of our unapproved prescription drugs team is to identify these products, and encourage companies to remove unapproved versions from the market, and begin the application process to obtain FDA approval.

A growing number of manufacturers have successfully obtained approval for formerly unapproved products. For example:

  • Bloxiverz (neostigmine methylsulfate injection), marketed by Éclat Pharmaceuticals and approved to reverse the effects of certain neuromuscular blocking agents after surgery, was approved in 2013, and,
  • Vasostrict (vasopressin), marketed by Par Sterile and approved to increase blood pressure in adults in vasodilatory shock whose blood pressure remains low despite administration of fluids and other efforts to raise it, was approved in 2014.
Cynthia Schnedar

Cynthia Schnedar, J.D., Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research

Such approvals highlight the strength of collaborations between FDA’s shortages staff, our unapproved drugs team, and the Office of New Drugs. These approvals are crucial for FDA: once a drug is approved, we know what ingredients are in the drug, how it is made, and that it has been shown to be safe and effective for its labeled use. Approval of formerly unapproved products also helps alleviate FDA’s concerns about a potential market disruption or shortage of these drugs, because the manufacturers of approved drugs have invested in a manufacturing process that helps to ensure the drug is produced the same way every single time, lowering the risk for shortage.

However, prescribers and their patients may sometimes think there is a shortage of product because once the manufacturer can produce an approved drug in sufficient quantities to meet market demand, the unapproved versions transition out of the market. To help allay such concerns, FDA’s unapproved drugs team works closely with the drug shortages staff to share information about the availability of the newly-approved product from the manufacturer, information that is then conveyed to patients and providers. This strong relationship between the different parts of the Agency facilitates adequate supply of safe and effective, FDA-approved drugs.

FDA is aware of another access-related issue as well when unapproved drugs are approved. If a single manufacturer is the sole maker of a newly-approved product, the price of the drug may be higher than what patients and prescribers paid for the unapproved drug. FDA welcomes manufacturers’ sensitivity to pricing of these newly approved versions. However, FDA is charged by Congress to ensure that drugs are safe, effective and properly labeled and does not factor costs into its drug approvals or safety related decisions. While approved drugs may cost more, patients are assured a safe and effective product.

FDA encourages companies to apply for approval of generic versions of newly-approved drugs since this would be anticipated to foster competition and promote price reductions. For example, neostigmine, a formerly unapproved drug, now has two approved manufacturers. FDA expects to receive more applications for approvals in the future.

Making safe and effective medicines available to patients is our number one goal. While working to bring FDA-approved drugs to market frequently involves exceptional challenges and complications, we believe that in the long run, our efforts enhance public health for all Americans.

CAPT Valerie Jensen R.Ph., is Associate Director of the Drug Shortage Staff, Center for Drug Evaluation and Research, FDA

Cynthia Schnedar, J.D., is Director of the Office of Compliance, Center for Drug Evaluation and Research, FDA

Providing Timely Patient Access to High-Quality, Safe and Effective Medical Devices

Jeffrey Shuren, M.D., J.D.

We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. For these patients, earlier access to promising new devices is critically important. At the same time, delayed access may mean the difference between life and death, or may result in irreversible disability.

Jeffrey ShurenIn weighing the benefits and risks of new technologies for these patients, we understand the need to place greater weight on the benefit of earlier access, and to also account for the risks of delayed access. That’s why  we’ve developed the Expedited Access Program (EAP): to speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.

Under this voluntary program, sponsors of devices for life-threatening or irreversibly debilitating conditions that meet an unmet need can request an EAP designation. Also under this program, CDRH staff- including senior management – work collaboratively with developers of such devices earlier and more often. These efforts include the creation of a Data Development Plan that provides predictability and leverages postmarket data collection. The Data Development Plan will shift premarket data collection to the postmarket setting, to the extent appropriate, taking into account the public health benefit of these devices, while still meeting the U.S. approval standard of reasonable assurance of safety and effectiveness. Starting April 15th, this program will be up and running and we will begin to accept requests for EAP designation.

The premarket data must be adequate to support FDA’s high standard for premarket review but can include data based on an intermediate endpoint or a surrogate endpoint reasonably likely to predict clinical benefit.

Another important feature of the EAP is how FDA decides that the benefits of a novel device for patients with life-threatening or irreversibly debilitating conditions outweigh its risks. Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.

If, after careful analysis, FDA determines that some data can be collected after the device is on the market, then patients in need will benefit sooner. A few of the factors that can enter into this analysis include a low probability of serious harm, a high likelihood that postmarket surveillance can quickly identify instances of serious patient harm and a high likelihood that postmarket data collection will be completed in a timely manner.

We consider this balancing of premarket and postmarket data collection to be so important that we made it one of our three 2014-2015 strategic priorities, along with strengthening the clinical trial enterprise and providing excellent customer service.

Today, we’re taking steps to implement that priority. In addition to issuing a guidance document outlining our EAP program for devices to treat or diagnose life-threatening or irreversibly debilitating conditions, we’re issuing a guidance on balancing premarket and postmarket data collection. It describes the circumstances under which postmarket data collection is appropriate for PMAs, whether or not they meet the criteria for the EAP, and provides many useful examples.

Once EAP products come to us for review, they will qualify for priority review. This feature, combined with the other elements of the EAP program, will reduce the time it takes to develop important new medical devices for patients with unmet medical needs and it will do so without ever lowering our standards.

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

FDA to Industry: Let’s Increase the Availability of Safe, Effective Animal Drugs

By: Martine Hartogensis, D.V.M.

Just as drugs for people benefit from FDA review to ensure their safety, effectiveness and quality, so do drugs for animals.

Martine HartogensisUnfortunately, this fact is ignored by some companies that sell unapproved animal drugs. By bypassing the FDA’s drug approval process, these firms potentially put the health of animals—and people—at risk. That’s why the FDA is working to get these products off the market.

There are different pathways to FDA approval and legal marketing of an animal drug product, but each pathway requires a drug company to expend both time and financial resources to generate the appropriate scientific evidence to support the approval. Companies that bypass the FDA drug approval process may be endangering the animals given unapproved drugs and people who either handle the unapproved drugs or eat food from animals treated with them. In addition, those who market unapproved drugs have an unfair competitive edge, and might prompt others to also break the law in order to compete in the marketplace. This slippery slope leads to a diminished supply of animal drugs that have been reviewed by the FDA for safety and effectiveness.

FDA’s rigorous review process also makes certain that the manufacturing process preserves the drug’s strength, quality and purity, and ensures that it has been consistently produced from batch to batch. FDA also requires that the product labeling is truthful and complete.

In some circumstances, the unapproved drug may be the only one of its kind available. In these cases, FDA often works with the company to develop the evidence that the product is safe and effective. Making innovative, FDA-approved animal medications legally marketable is an important part of FDA’s mission to protect the public health.

But while being helpful, FDA is also stepping up efforts to combat illegal animal drug sales, both on the ground and online.

We’ve recently issued warning letters to several marketers, distributors and manufacturers of unapproved animal drugs and expect to issue more in the coming year. Our enforcement actions could include seizures of violative products and/or injunctions against manufacturers and distributors of unapproved animal drugs. We also continue to regularly update the agency’s web page on unapproved animal drugs with information for veterinarians and industry.

We’ll continue to do all we can to make the animal drug approval process as straightforward and efficient as possible. But we need industry to do its part, so that we can continue to make more safe and effective drugs available to veterinarians, animal producers and pet owners.

Martine Hartogensis, D.V.M., is Deputy Director, Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine