Meeting Face-to-face Makes All the Difference

By: Heidi C. Marchand, Pharm.D.

While to many, the cherry blossoms in Washington, D.C., signal spring, for my office the season means bountiful opportunities to meet with groups in town for meetings and conventions in our capital city.

Heidi MarchandPatient and health professional advocacy groups that are some of FDA’s key stakeholders come to FDA Headquarters in nearby Maryland —or we go downtown to their meeting sites—for a mutual exchange of information that often has a profound influence on how we do our jobs protecting and promoting the public health.

So far, we have had informative discussions with groups as varied as the American Association of Nurse Anesthetists, the American Academy of Pediatrics, the American Celiac Disease Alliance, the ALS (Amyotrophic lateral sclerosis) Association, and Parent Project Muscular Dystrophy.

Because we are part of the Office of the Commissioner, we’re familiar with the agency across its various centers and are ideally positioned to connect stakeholders with the experts best suited to answer questions and offer assistance.

We hear from individuals on the front lines—parents of patients with heartbreaking childhood diseases, nurses who witness firsthand the consequences of a medical device that fails to work properly, patients who want to know where and how they can participate in clinical trials.

Many are experts in their area of advocacy—they’ve had to be—and their insights are invaluable.

Putting What We Learn To Good Use

For example, as we developed a rule, mandated by Congress, to define the term “gluten-free” for voluntary use in food labeling, we not only opened the proposed regulation up for public comment on two separate occasions, but we also conducted listening sessions with groups representing people with celiac disease, who must avoid consuming gluten but want a diverse and nutritious diet. They talked about the difficulties they face in trying to identify foods that won’t endanger their health, shared information about their understanding of challenges facing the food industry, and discussed the science that underlies this issue. This information helped us to ensure that the final rule was responsive to their needs. Now people with celiac disease can be assured that if they see “gluten-free” on food labels, that term has a specific, nationally uniform (and federally enforceable) definition.

Of course, our outreach efforts extend beyond these meetings. Our staff keeps in close touch with patient and health professional advocacy groups throughout the year, and through our FDA Patient Network website where we provide information on public meetings, current FDA draft guidances, clinical trials, and drug and device approvals. In addition, our patient newsletter keeps our stakeholders apprised of this and other important work FDA is doing.

But there’s nothing like meeting face-to-face across a table.

We listen to what our constituents have to say, we take it to heart, and we share it with our colleagues. What we learn through these conversations informs our work. It becomes part and parcel of the regulations we put into place to promote and protect the public health.

Heidi C. Marchand, Pharm,D., is Assistant Commissioner in FDA’s Office of Health and Constituent Affairs

Stroke Awareness Month: What’s New in Stroke Therapies?

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

Stroke is the leading cause of severe disability, and the fifth leading cause of death for all Americans. The burden is worse in minority communities; minorities have higher stroke risks, strokes at an earlier age, and more severe strokes. For example, African-Americans are twice as likely to die from a stroke compared to Whites.

Jovonni SpinnerOften this is because people do not know the warning signs (e.g., sudden numbness, confusion, or loss of balance), or the risk factors that lead to stroke, like high blood pressure, diabetes, and an irregular heart rhythm (atrial fibrillation, or AF). Some minority groups also suffer disproportionately because of cultural and language barriers- which can lead to a delay in treatment or not seeking treatment at all.

Aspirin Therapy: Who should use it?

Although there is broad agreement about the benefits of aspirin in secondary prevention of stroke, (the use of aspirin in people who have already had a stroke) there has been debate in the scientific community about the benefits and risk of using aspirin for primary stroke prevention, i.e., in people without a prior stroke. The Food and Drug Administration has not recommended that use.

To help dispel myths and provide accurate information, we have issued consumer and provider friendly guidance on the appropriate use of aspirin therapy.

Here is the latest evidence on who should and should not use aspirin for stroke prevention.

Primary prevention: In patients who have never had a stroke, aspirin therapy can increase their risk for bleeding in the stomach and brain and a reduction in strokes with aspirin has not been established.

Secondary Prevention: In patients who have already had an ischemic stroke, which happens when a blood vessel that supplies blood to the brain becomes blocked by a blood clot; aspirin therapy has been shown to decrease the risk of having a subsequent event. In general, the benefits may outweigh the risks for these patients.

Aspirin is, of course, readily available in drug stores and grocery stores. Before using it, however, patients should discuss with their healthcare providers whether aspirin therapy is the right course of action for stroke prevention.

Drug Trials Snapshot: Savaysa

On another note, In January 2015, FDA approved Savaysa, a drug used to reduce the risk of stroke in patients with AF, a type of abnormal heart rhythm. This is a blood thinning medication similar to several other recently approved anti-coagulants and an older drug, warfarin. All of these drugs reduce the chance of stroke in patients with this condition by more than 50%. But note, that for patients with kidneys that work really well, Savaysa did not work as well as warfarin.

More than 21,000 people with AF participated in the Savaysa clinical trial.  Clinical trial data, which are made available from the “Drug Trials Snapshot”, showed a large stroke reduction and no meaningful differences by sex, race (Whites versus Asians), or age (greater than 75 years) for the drug’s performance or side effects (e.g., major bleeding), a finding that is also true for the other anti-coagulants. Other minority groups were under-represented in this trial, so data are not available for those groups.

The Drug Snapshot is part of FDA’s transparency initiative that displays the clinical trial data analyzed by subgroup (e.g., sex, race, and age). This is an important initiative because it provides information on clinical trial participation among varying groups.

Here at FDA, we strive to make data transparent and easily accessible to our stakeholders. The Office of Minority Health is leading FDA’s efforts to encourage diversity of participants in clinical trials and assess possible differences in effects among varying groups. We know that demographic subgroups (e.g., minorities, women) can respond differently to medications and clinical trial participants should reflect the populations that will most likely use these products.

Visit our website or follow us on Twitter to find out more information about our research programs, outreach, and communications.

www.fda.gov/minorityhealth

@FDAOMH

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

Blue Bell and the Very Real Impact of the Food Safety Modernization Act

By: Michael R. Taylor

Could the deadly outbreak of illnesses tied to contaminated ice cream have been prevented? It’s an important question, one that is on the minds of many in the wake of the multi-state outbreak of Listeria monocytogenes tied to ice cream produced by Blue Bell Creameries.

Michael TaylorAbove all else, we need to acknowledge the tragic aftermath. Our hearts go out to the friends and family members of the victims – the 10 people who were hospitalized and the three who died.

Our mission in the face of such tragedies is to work to keep them from happening again, first by investigating the cause. If products are found to be contaminated with Listeria monocytogenes or other pathogens, we work with companies to recall anything that has the potential to cause illness. The FDA joins with other federal agencies, states, and industry, while also communicating directly with consumers — all in an effort to ensure that more people don’t get sick or worse.

But more needs to be done, and more is being done. Congress passed the FDA Food Safety Modernization Act (FSMA) in December 2010 because of outbreaks like this, because of a widespread concern among legislators, consumers and industry about foodborne illnesses that kill thousands each year.

Ultimately, the only way we will achieve the goals that we are focused on—the goals that consumers expect us to achieve, and that industry wants us to reach—is if we have a system in which industry is systematically, every day, putting in place the measures that we know are effective in preventing contamination. And it’s not only a domestic issue; it’s an import issue. We’ve got to build prevention into the food safety system globally.

There’s no magic wand here. This is the most sweeping regulatory overhaul in the agency’s history and we’ve got to work systematically to put the right regulations in place. In the four years since FSMA became the law, we have been actively establishing the regulations that we will be issuing in final form beginning later this year.

For example, the preventive controls for human food rule, if finalized as proposed, would require that companies like Blue Bell have a written food safety plan, based on an analysis of likely hazards, and companies would have to show us that plan during inspections. Listeria monocytogenes is a classic example of a hazard that a company should be controlling. Under the proposed standards, companies would be required to have the right controls in place to minimize hazards and would have to verify that their controls are working.

We have in FSMA not only new, enforceable standards, but much stronger inspection and enforcement tools to make sure the standards are being met, such as access to company records and mandatory recalls –authorities we didn’t have before. Most companies want to do the right thing; many are doing it now. Through this law we want to promote strong food safety cultures and create real accountability throughout the industry.

We see broad support for implementing FSMA throughout our stakeholder community and among many people we talk to in Congress. President Obama’s 2016 request for $109.5 million in new budget authority to implement FSMA is crucial. If we receive that funding, we can move forward to implement this new, modern system in an effective and timely way. If we do not get the funding, we will lose momentum, and implementation will be badly disrupted.

No law can guarantee zero risk, from contaminated ice cream or any other food that has come in contact with a dangerous bacteria or other harmful substance. But FSMA is about providing assurances that the food system is doing everything it can to prevent problems and to provide food in grocery stores and restaurants that is as safe as it possibly can be.

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

FDA Teams With National Forum to Reduce Deaths from Heart Disease: Program is first of its kind

By: Heidi C. Marchand, Pharm.D.

In the U.S., only about 1 in every 4 prescriptions is taken as directed by a health care provider – a problem that costs our nation more than 125,000 lives a year. Millions of Americans with heart disease – the nation’s No. 1 killer – are especially vulnerable.

Heidi MarchandTo stem that tide, FDA has teamed with the nonprofit National Forum for Heart Disease and Stroke Prevention to advance the cause of a heart-healthy and stroke-free society.

FDA’s Office of Health and Constituent Affairs has signed a Memorandum of Understanding with the National Forum to promote and increase the use of health knowledge, skills and practices by the public in their daily lives. The five-year agreement is a first-of-its-kind cooperative public education program to reduce the burdens of heart disease and stroke.

Heart disease, which kills 1 in 4 Americans, can be managed. To prevent heart attacks, transient ischemic attacks and other cardiac events, doctors prescribe medications and lifestyle therapies (e.g. heart-healthy diets). Because medication is not readily adhered to – and neither are lifestyle treatments – millions of people suffer from preventable cardiac episodes. As a nation, lack of medication adherence (which can be as simple as not getting a prescription filled or refilled) costs more than $100 billion annually in excess hospitalizations.

To confront this problem, FDA is taking the lead in support of Million Hearts®, a national initiative of the Department of Health and Human Services to prevent 1 million heart attacks and strokes by 2017. A key partner in that mission is the National Forum, whose members include more than 80 U.S. and international organizations representing public, private, health care, advocacy, academic, policy and community sectors.

Together we will:

  • Explore, demonstrate and evaluate innovative health promotion concepts.
  • Exchange information on nutrition, heart disease, and ways to increase the number of patients who take their medication and/or therapy.
  • Identify and systematize best practices in behavior modification education.
  • Develop concepts for community-based interventions.

Our goals are clear: create recommendations to improve compliance with prescribed medical therapies and implement the recommendations to improve the lives of patients living with heart disease.

FDA’s Dr. Helene Clayton-Jeter and Dr. Fortunato “Fred” Senatore are leading a diverse team in identifying strategies to help patients take their medicines as directed and follow the advice of their doctors.

Concurrently, the National Forum will recruit a Therapy Adherence Steering Committee, made up of experts and stakeholders from physician and nursing groups, pharmacy (retail/system), behavioral health, consumer/patient groups and others invested in complying with medical therapy.

We’ll then jointly develop action plans for high-probability, high-yield strategies to promote heart health by helping ensure that patients take their medicines and adopt healthier lifestyles. Our plan is to complete all steps in the next several years.

We cannot fix this problem overnight. But by addressing it strategically, we can move forward and improve the odds of preventing and surviving heart disease and stroke among Americans.

Heidi Marchand, PharmD, is Assistant Commissioner in FDA’s Office of Health and Constituent Affairs

Biosimilars: New guidance from FDA to help manufacturers develop more treatment options

By: Leah Christl, Ph.D.

FDA has taken important new steps to continue to help manufacturers develop biologic products called biosimilars. Biosimilars are highly similar to, and have no clinically meaningful differences from, an already approved biological product. Biosimilars can provide more treatment options for patients, and possibly lower treatment costs.

Leah ChristlIn early March, FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), used to help stimulate growth of white blood cells in patients with cancer and help them fight infection.

That’s a great start and we are pleased to see the progress. Manufacturers are working hard to develop more biosimilars for the U.S. market. By nature, biologic products are highly complex molecules, so developing biosimilar versions of these products is challenging. FDA is also working hard to help those manufacturers bring more biosimilars to the market.

Over the past few weeks, we have released four guidances for industry — useful tools to help manufacturers navigate the new terrain of biosimilar development.

  • One assists companies in demonstrating that a proposed product is indeed biosimilar to an existing biologic product, and is intended to provide clarity to manufacturers about the expectations for a biosimilar development program.
  • A second focuses on the analytical studies that demonstrate that the product is “highly similar” to an existing biological product, which supports the demonstration of biosimilarity.
  • A third guidance answers common questions about the biosimilar development and application process and contains information intended to provide a better understanding of the law that allows biosimilars development. 
  • A fourth, still in draft form — which means we are accepting public comment — answers a variety of additional questions that have arisen regarding the biosimilars development process.

Each of these guidances was developed to help industry more efficiently and effectively develop new biosimilars for patients in need.

Many of our most important, but also expensive, drugs are biological products. These products are used to treat patients who have a variety of serious and life-threatening medical conditions including rheumatoid arthritis, psoriasis, diabetes, and cancer.

Having more approved biosimilars is good for public health. FDA looks forward to continuing to help manufacturers develop these important products.

Leah Christl, Ph.D., is FDA’s Associate Director for Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research

The 2014 FDA Food Safety Challenge: And the Finalists Are…

By: Palmer Orlandi, Ph.D.

I am delighted to announce the finalists in FDA’s first Food Safety Challenge, a ground-breaking effort to better protect our food supply by fostering innovation in technologies that will more quickly detect pathogens in produce.

Palmer OrlandiLast September, we invited scientists, academics, entrepreneurs, and innovators from all disciplines to compete by submitting concepts that could improve and accelerate the detection of these disease-causing bacteria in foods. We received 49 submissions.

The five finalists whose proposals will enter the next phase of the Food Safety Challenge are teams of researchers from these companies and universities:

  • Auburn University, Auburn, Ala.
  • Pronucleotein Inc., San Antonio, Texas
  • Purdue University, West Lafayette, Ind.
  • University of California, Davis, Calif.; Dr. Bart Weimer; and Mars, Inc.
  • University of Illinois, Urbana-Champaign, Ill.; and Purdue University

(Purdue is represented twice, teaming with University of Illinois colleagues in one proposal and going solo in another, with different researchers on each team.)

Each team has developed ingenious new technologies for detecting food pathogens that could be real game changers in our ongoing fight against foodborne illness. They will each receive $20,000 and advance to the next stage in the Challenge. The winner or winners (there can be more than one) will share the remainder of the $500,000 total prize.

But before I describe the next step, let me remind you why this Challenge is vital to FDA’s mission to promote and protect the public health.

  • The Centers for Disease Control and Prevention (CDC) estimates that foodborne illness sickens 1 in 6 Americans  annually, resulting in about 3,000 deaths.
  • The overall negative economic impact of foodborne illness in the United States may be as high as $77 billion per year.
  • Salmonella is the leading cause of death and of hospitalization related to foodborne illness.

We believe that by reaching out through this Challenge to entrepreneurs, academia, and the larger scientific, innovation and problems-solving communities, we can view our food safety problems through a different lens. It’s a way to consider approaches, and possible solutions, through the eyes of innovative thinkers, and to use technologies we may not have considered.

What Happens Next?

Now that our panel of expert judges from FDA, CDC, and the U.S. Department of Agriculture has narrowed the competitive field down, we enter the Field Accelerator phase of the Challenge. With the guidance of FDA food safety and pathogen-testing experts, finalists will

  • refine their submissions,
  • clarify their concepts,
  • maximize their impact on food safety,
  • check that they are in line with FDA’s needs and capabilities,
  • and ensure that the proposed ideas can be reasonably executed.

The finalists will participate in a “boot camp” with FDA experts on May 13, 2015 to help strengthen their concepts and applicability to FDA’s testing process. “Demo Day” will be held on July 7, 2015 in College Park, Md. The finalists will present their improved proposals to the judges and a live audience in FDA’s Center for Food Safety and Applied Nutrition headquarters.

I, for one, can’t wait to see the solutions the finalists will come up with. We believe that by thinking outside the box, we can find new ways to help assure the American public that the foods they eat and serve their families are safe.

Palmer Orlandi, Ph.D., is Acting Chief Science Officer and Research Director in the FDA’s Office of Foods and Veterinary Medicine.

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

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