Working to Raise Awareness and Reduce Health Disparities

By: Jonca Bull, M.D.

Minority Health Month imageApril is National Minority Health Month and this year’s theme is “Bridging Health Equity Across Communities.”

FDA’s Office of Minority Health (OMH) is committed to the HHS mission of advancing health equity, and our office works year-round to advance FDA’s message of ensuring the safety and efficacy of our nation’s food supply and medical products to all communities, but with a focus on minority groups. The first HHS Office of Minority Health was established nearly three decades ago and FDA’s own office came into being in 2010.

Jonca Bull, M.D., is Director of FDA’s Office of Minority HealthIn the intervening years, we have made significant progress. But we are reminded daily that there is still more to be accomplished in the fight to reduce and eliminate health disparities.

Today, minority communities and those at the lower socioeconomic rungs still remain disproportionately burdened by chronic disease and are much more likely to succumb to certain illnesses.

Within the past year, we have worked diligently to connect our communities to resources to help educate and raise awareness about these issues. Highlights from our two programmatic teams include:

Outreach and communications –

Released English and Spanish language videos to encourage minority participation in clinical trials, with the most recent video being released this month;

  • Worked closely with the health fraud team in the Office of Regulatory Affairs to raise awareness about tainted and fraudulent products that target some ethnic groups;
  • Exhibited and presented at nearly a dozen conferences throughout the year; and,
  • Spearheaded the agency’s Language Access plan to help ensure that FDA materials are available to all consumers in their native language.

Research and Collaboration –

  • Worked with FDA centers and external partners to support research studies around minority health and health disparities. Projects included: Racial Disparities in Multiple Myeloma, Underutilization of Generic Medications in Underserved Patients, and Advertising and Promotional Labeling in Adult Immunization Disparities.
  • Funded multiple Centers for Excellence in Regulatory Research Science and Innovation (CERSI) projects with Georgetown University (Targeting triple negative breast cancer in African American women), University of California San Francisco/Stanford (Safer Labeling of Pediatric Medications: Reducing Literacy-related Health Disparities among Chronically Ill Adolescents), Johns Hopkins University (Workshop Clinical Trials: Assessing Safety and Efficacy for a Diverse Population);
  • Supported a genomics and health disparities fellow at Harvard University School of Medicine; and,
  • Hosted more than half a dozen fellows and pharmacy students from Howard University, the University of Washington, and Florida Agricultural and Mechanical University, among others.

In addition, last fall, OMH issued a draft guidance document titled, Collection of Race and Ethnicity Data in Clinical Trials-Guidance for Industry and FDA Staff with the goal to ensure that subpopulation data is collected consistently by industry. This document outlines FDA’s expectations for, and recommendations on, the use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated medical products conducted in the United States and abroad. We also hosted a webinar to walk through the document.

Working collaboratively within FDA and with external stakeholders, we will continue promoting and protecting the health of diverse populations through research and communicating of science information that addresses health disparities.

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

For more information read: The FDA Supports Research to Reduce Health Disparities

FDA Takes Action Against Fraudulent Cancer Products

By: Donald D. Ashley, J.D., and Douglas Stearn, J.D.

A cancer diagnosis often provokes a sense of desperation. Unfortunately, rogue operations exploiting those fears peddle untested and potentially dangerous products, particularly on the internet. FDA responds in two ways: with compliance and enforcement actions against unscrupulous companies and with consumer education to decrease demand.

Donald Ashley

Donald D. Ashley is director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research

Every one of FDA’s product centers and the FDA’s Office of Regulatory Affairs (ORA) has staff devoted to rooting out health fraud scams. These teams regularly investigate consumer complaints and monitor the stores and online marketplaces where such products are advertised. Recently the Center for Food Safety and Applied Nutrition and the Center for Drug Evaluation and Research teamed up with ORA to search the Internet and social media for bogus products that falsely claim to diagnose, treat or cure cancer, a violation of federal law.

It was a challenging assignment.

Those marketing fraudulent products – primarily or exclusively on the internet – attempt to subvert compliance and enforcement efforts by changing the names of their products, their companies, and/or their websites.

Nevertheless, today we are announcing that 14 companies peddling bogus cancer cures have received warning letters from FDA. Warning letters are a primary compliance tool that FDA uses to address violations of the Federal Food, Drug and Cosmetic Act.

Douglas Stearn

Douglas Stearn is director of the Office of Enforcement and Import Operations within FDA’s Office of Regulatory Affairs

These companies used slick ads, videos, and other sophisticated marketing techniques, including testimonials about miraculous outcomes. Often a single product was promoted as a treatment or cure for multiple diseases in humans and animals. Hoping to skirt the law on a technicality, some sellers made false claims and then in small print provided a disclaimer that their products are not intended to diagnose, treat, cure or prevent any disease.

Making such obvious claims and then saying later that you are not doing so might seem clever, but the technique does not comply with federal laws intended to protect public health.

Each of these companies has 15 working days to respond with a plan to come into compliance with the law.

If necessary, FDA also has authority to take further action, including criminal prosecutions, product seizures, and injunctions. Companies that fail to come into compliance after receiving a warning letter can for example, face criminal prosecution and court-ordered decrees that require them to recall products and get written permission from FDA before resuming operations. The violations identified in the warning letters, if not corrected, are punishable by up to one year in federal prison, five years’ probation and a fine of either $100,000 or twice the gain from the offense.

FDA works diligently to monitor and take action against companies marketing unsafe products online and has issued more than 90 warning letters over the past decade to companies marketing fraudulent cancer products.

image of fake cancer curesConsumer education is critical in combating the dangers posed by these types of products. Thus, our recent cancer fraud initiative includes a push to raise consumer awareness and thereby decrease demand. Efforts include contacting media outlets that reach millions of consumers, posting a Consumer Update article at FDA.gov, and encouraging consumer groups, trade associations, and others to help us spread this important “buyer beware” information.

The message to consumers is this: These products are untested. Some contain ingredients that may be a direct risk to your health. The ingredients may interact in a dangerous way with professionally-prescribed treatments. They are not a substitute for appropriate treatments. Using these products can waste your money, and, more importantly, endanger your health.

Donald D. Ashley is director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research

Douglas Stearn is director of the Office of Enforcement and Import Operations within FDA’s Office of Regulatory Affairs

Redefining the Term “Healthy” on Food Packages – Public Process Plays a Crucial Role

By: Susan Mayne, Ph.D., and Douglas Balentine, Ph.D.

When you see the word “healthy” used on a food package, what does that mean to you?

Susan Mayne

Susan Mayne, Ph.D., is Director of FDA’s Center for Food Safety and Applied Nutrition

It’s FDA’s job to make sure that terms like “healthy,” which many people rely on to make food choices for themselves and their families, are something that they can truly count on. And we’ve seen that the ability to include the claim “healthy” actually encourages food companies to produce healthier foods. Back in the 1990s, the agency used the best nutritional science available at that time to define what “healthy” meant. And so, over the past two decades, food packages could be labeled as healthy if they met certain criteria for the content of fat, saturated fat, sodium and cholesterol and contained certain minimum amounts of nutrients like vitamins and minerals.

But nutrition science has evolved. Whereas in the past we placed greater emphasis on total fat, we now know that not all fats are alike, and some are better for health than others.  And while the focus on ensuring that people are getting the right amounts of different nutrients still matters, other things matter as well, such as food groups or the combinations of different foods and beverages in the diet.

Doug Balentine

Douglas Balentine, Ph.D., is director of the Office of Nutrition and Food Labeling at FDA’s Center for Food Safety and Applied Nutrition

So the question is: Can FDA update the definition of “healthy” in a way that makes sense and reflects our most current understanding of nutrition science today? FDA’s answer is: We want to do that, and we want the public’s help to make sure we get it right.  We want to hear from food companies that make and market food, from experts who study nutrition, and from consumers who, after all, are the ones to whom “healthy” claims are directed.

That goal prompted us to hold a public meeting in March 2017 on the term “healthy” on food labels, and we were delighted that hundreds of participants joined in person or via webcast. But if we were looking for an easy answer and widespread agreement on the definition of healthy, we didn’t find it there! The range of opinions we heard underscores just how complex the process of revising the definition will be.

Let’s take, for example, the different views of four participants in a panel discussion on stakeholder perspectives.

  • Kind Snacks, which has petitioned FDA to change its “healthy” definition, proposed, in part, that foods be defined as healthy if they contain a “meaningful amount” of foods that comprise a healthy diet and that don’t contain low- or no-calorie sweeteners or synthetic colors.
  • ConAgra Foods presented a framework for defining “healthy” by ranking foods based on their nutritional makeup, an approach that permits greater flexibility. If higher amounts of “food groups to encourage” are present, then there is some room for a food to be listed as healthy even if there are some “nutrients to limit” as well.
  • The Center for Science in the Public Interest said that a “healthy label” shouldn’t be a marketing tool that helps marginally better processed foods compete with fruits, vegetables and other truly healthy foods.
  • And the Academy of Nutrition and Dietetics, after talking to its members, said it could not come up with a good definition for “healthy” that FDA should adopt.

There were different opinions on whether we should continue to define “healthy” based solely on specific nutrients that are considered to play a role in lowering the risk of chronic disease. In that regard, some favored having the new definition continue to include certain beneficial nutrients, such as vitamins, minerals and fat. Others suggested it be based instead on beneficial food groups to – such as whole grains, fruits and vegetables – while still others opted for a combination of the two.

Participants also urged us to consider the goal of redefining “healthy” before deciding the criteria. Is the term primarily an educational tool? If so, then we must be transparent about what the term means because people view the word healthy differently depending on their perspectives and values. Alternatively, is the definition intended to be a guideline for industry in making claims about their products, or, is it a way to spur product reformulation towards healthier foods?

We welcome the diversity of comments we received – they will be added to the nearly 900 we’ve received from the public since September 28, 2016 when we published a Request for Information on the word “healthy.” To give the public time additional time to comment after last month’s meeting, we are extending the comment period until April 26.

We will study the comments carefully as we consider how to move forward, knowing it will be a challenging task, given the diversity of opinions, as the public meeting demonstrated. But the meeting also showed that an updated, and appropriate, definition of healthy is important to the American people, industry, health care professionals, food scientists, and other experts. Towards that end, FDA is committed to continuing this important dialogue.

Susan Mayne, Ph.D., is director of FDA’s Center for Food Safety and Applied Nutrition

Douglas Balentine, Ph.D., is director of the Office of Nutrition and Food Labeling FDA’s Center for Food Safety and Applied Nutrition

Improving the Safety of Imported Foods Through Partnerships

By: Susan Mayne, Ph.D., Camille Brewer, M.S., R.D., and Donald Prater, D.V.M.

Susan Mayne

Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition

At FDA, we recognize that the partnerships we build with other nations are key to our success in giving American consumers confidence in the safety of the foods they choose to serve their families.

In passing the FDA Food Safety Modernization Act (FSMA), Congress provided FDA with new authorities to help ensure that domestic food is as safe as possible and that imported food meets U.S. food safety standards. These new authorities to enhance the safety of imported foods take into account a variety of food safety partnerships, including several that FDA has had in place for years.

FDA recently held a two-day public hearing in which we received input from domestic and international food safety experts on how we can build on these strategic partnerships. The safety of imported foods is of great interest to all of us and of utmost concern to the American public. About 15 percent of the U.S. food supply is imported, including nearly 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood. Those imports to the United States come from more than 200 countries and about 125,000 firms.

Camille Brewer

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

What we took away from this hearing, a call to action that will guide us going forward, was a clear message from experts: There are a range of partnership tools that can enhance the safety of imported foods – from capacity building, to credible third party audits and certifications, to sophisticated forms of regulatory cooperation – and each should be used in a way that ensures it is appropriate for its intended purpose.

Countries that export food to the U.S. represent a continuum of food safety capacities and capabilities, and for that reason, one size doesn’t fit all when it comes to partnerships. Experts shared their experiences on how we can work with trading partners that need help in building their food safety systems, which, in turn, can help improve the safety of food imported into this country. Attendees discussed how capacity-building programs can be implemented, and how we can make these programs accessible and useful to various regions in the world.

At the other end of the spectrum: How does FDA leverage the knowledge and best practices of countries that have robust food safety systems, and that we have officially recognized as providing a comparable level of public health protection? So far, FDA has completed official recognition with three such countries – New Zealand, Canada and, just this week, Australia.

Don Prater

Donald Prater, D.V.M., Acting Assistant Commissioner for Food Safety Integration in FDA’s Office of Foods and Veterinary Medicine

Imported foods must be produced in a way that provides the same level of public health protection as that required of domestic food producers. Some of the questions we considered included: How will it be decided that a measure or procedure used in lieu of an FDA requirement provides the same health protection? How are countries ensuring parity in audits, inspections, verification, and overall oversight?

We also discussed whether, and how, federal agencies might leverage activities and resources with the private sector. How can we consider the role of private entities, such as companies that audit against various private food safety standards, in our oversight of imports?  And we considered the value of export control programs that are specific to certain commodities in terms of risk-based surveillance and planning.

The bottom line? We can use a variety of approaches to enhance the safety of imported food.

Overall, the hearing provided us with a rich tapestry of ideas, opportunities, and challenges that FDA will consider as we enhance our partnership activities. The key is understanding that one size doesn’t fit all.

Click here for the hearing webcast, transcript and additional background. 

Click here for ‘A Conversation with Donald Prater’ on advancing the safety of imported food.

Susan Mayne, Ph.D., is Director of FDA’s Center for Food Safety and Applied Nutrition

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

Donald Prater, D.V.M., is Acting Assistant Commissioner for Food Safety Integration in FDA’s Office of Foods and Veterinary Medicine

America’s Got Talent – Regulatory Science Style

By: Stephen Ostroff, M.D.

Veni Vidi Vici. It translates into English as “I came, I saw, I conquered.” It also happens to be the name chosen by one of the winners of the recently held America’s Got Regulatory Science Talent Competition.

America's Got Regulatory Science Event

Dr. Ostroff and FDA staff discuss projects with students from the University of Maryland CERSI.

FDA recognizes that young scientists are our future. Now in its fifth year, America’s Got Regulatory Science Talent is one of a number of initiatives FDA supports to encourage young scientists to pursue careers in the rapidly maturing field of regulatory science.

Each year, teams from the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI), and the University of Rochester’s Clinical and Translational Science Institute (CTSI), compete by presenting their proposed solutions to a current challenge in regulatory science. The students identify the needs by consulting eight priority areas identified in FDA’s Strategic Plan for Regulatory Science.

Winners are decided by a panel of judges after evaluating each presentation for its quality and novelty, and the proposed solution’s potential significance and feasibility. The winning teams come to FDA to formally present their ideas and have discussions with Agency scientists who are working in their project area. The event, held on April 12th, was sponsored by the Office of Regulatory Science and Innovation (ORSI) which is located in the Office of Chief Scientist. The winning teams certainly came, saw, and conquered.

This year’s winners are:

University of Maryland CERSI

Dr. Ostroff with the University of Maryland teams

Dr. Ostroff with the teams from the University of Maryland CERSI

1st Place Team – Veni Vidi Vici

A high-visibility universal labelling system to communicate risks of hazardous drugs. Wonder if your prescription medication has some dangerous side effects that may be noted in “fine print” – or even nowhere – on the label? A universal symbol in red and yellow in a prominent place on the label is the “Veni Vidi Vici” Team’s solution.

2nd Place Team – Biomarker Boys

Platform to improve transparency for biomarker integration in Accelerated Approval pathway. Tackling a challenge experienced in this growing area of biomedical innovation, the “Biomarker Boys” created a form that facilitates transparent and structured integration of biomarkers into rare disease state drug development.

University of Rochester CTSI

Dr. Ostroff with the University of Rochester teams

Dr. Ostroff with the teams from the University of Rochester CTSI

1st Place Team – Simple English Explanation Directive (SEED)

Making clinical trial results more accessible and functional. Team “SEED” takes the incredibly complicated language that is often found when describing a clinical trial, and puts it in easy-to-understand form.

2nd Place Team – 3-Defining Patient Matched Implants

A streamlined process to test 3-D printed personalized implants. The “3-Defining Patient Matched Implants” Team decided that a quality systems approach is needed to streamline the process of validating the integrity of individual patient-matched 3-D printed implant systems. Their proposal introduces an alternative approach to the current method used in 3-D printing to ensure implants are safe for implantation.

This competition reminds us that good science makes for good regulation. And it was great to see the outside-the-box thinking and innovative approaches these contestants took in addressing some of the challenges that FDA faces with the products we regulate. It’s also a good reminder that the future of regulatory science depends on training and education – and we cannot underestimate the importance of educational activities like these.

The innovative approaches from this year’s teams also show the power of collaboration, mirroring the collaborative approach FDA takes in leveraging the brainpower of our teams of scientists, engineers, statisticians, social and behavioral scientists, medical officers, communicators, and others. The teams from the University of Maryland and the University of Rochester demonstrate just how teamwork produces great results.

Congratulations to the schools for organizing the competitions and to the FDA mentors who encouraged the competitors. Each year the quality of the work improves and I’m certain it will benefit patients and consumers over the coming years. Please check out this year’s talent –including a presentation from a freshman at Maryland. Who knows? Maybe one of these students will be FDA Commissioner some day!

To see the finalists present their innovative solutions to regulatory science challenges, visit FDA’s America’s Got Regulatory Science Talent web page.

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

FDA flickr photos from FDA’s America’s Got Regulatory Science Talent 

‘Organs-on-Chips’ Technology: FDA Testing Groundbreaking Science

By: Suzanne Fitzpatrick, Ph.D.

There are many things you might envision putting on a chip. It’s unlikely that a human organ is one of them.

Suzanne FitzpatrickBut creating human organ systems in miniature on micro-engineered chips about the size of a AA battery is a revolutionary testing technology that has captured the attention of food scientists at FDA. And FDA has a leading role in evaluating this science, designed to provide a more precise model for studying the effects of potentially harmful chemical and biological hazards in food, cosmetics or dietary supplements than is now available.

On April 11, 2017, FDA announced a multi-year research and development agreement with a company called Emulate Inc. to evaluate the company’s “Organs-on-Chips” technology in laboratories at the agency’s Center for Food Safety and Applied Nutrition, one of a number of FDA efforts to help evaluate this chip technology. The flexible polymer organ-chips contain tiny channels lined with living human cells and are capable of reproducing blood and air flow just as in the human body. The chips are translucent, giving researchers a window into the inner workings of the organ being studied.

Research will begin with a liver-chip but the agreement may expand in the future to cover additional organ-chips, including kidney, lung and intestine models. The ultimate goal is to predict how specific organs will respond to exposure to potential chemical hazards found in foods, cosmetics and/or dietary supplements with greater precision than other methods currently being used, such as cell-culture or animal-based tests.

Emulate Chip

Chip image courtesy of Emulate Inc.

Organs-on-chips have been the focus of a public-private collaboration between FDA, the federal Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH) since 2012. Millions of dollars in grants have been awarded to universities nationwide to advance this research, including Harvard University and the Massachusetts Institute of Technology. Emulate was founded by researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University.

The chips were first developed to evaluate the effectiveness of drugs but have come to be seen as a potentially useful technology in our efforts to ensure the safety of the foods and cosmetics we regulate. For example, they can be put to work to see how the body processes an ingredient in a dietary supplement or a chemical in a cosmetic and how a toxin or combination of toxins affects cells, information that ultimately can be used to help assess risks to human health.

In some ways, science is like a recipe in that both can go through a number of incarnations before they work. There’s a lot of experimenting and tweaking, collaborating and comparing. And that’s what we’ll be doing at FDA with the organs-on-chips research. Science is the foundation of FDA’s decisions but many people don’t realize how much scientific research is conducted by the agency. We’re excited to be at the forefront of this ground-breaking research, which may one day be routinely used to safeguard public health.

Wondering how this Organs-on-Chips technology works? Click here.

Suzanne Fitzpatrick, Ph.D., is the Senior Advisor for Toxicology in FDA’s Center for Food Safety and Applied Nutrition

PRISM Identifies Vaccine Safety Issues

By: Azadeh Shoaibi, Ph.D., M.H.S.

The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors.

Azadeh ShoaibiBut at FDA, it means a powerful, computer-based system that separates critical bits of information from vast streams of healthcare data in order to investigate adverse events and determine if there is a connection to a specific vaccine. And while the FDA prism–called Post-licensure Rapid Immunization Safety Monitoring System (PRISM)—might not have such a colorful name, it’s a bright light in the agency’s continual efforts to identify adverse effects in a timely manner.

PRISM is a cooperative effort between FDA’s Center for Biologics Evaluation and Research and its partners in the health care and medical insurance communities. It analyzes health insurance claims data from four national healthcare plans: Aetna, HealthCore (Wellpoint), Humana, and OptumInsight (United Healthcare).

Prism image

PRISM is a computer-based vaccine safety monitoring system that separates out critical information from vast streams of healthcare data. A part of the Sentinel Initiative of FDA, PRISM broadens the agency’s ability to monitor critical healthcare products in support of its mission to protect and advance public health.

Since it was first inaugurated in 2010, PRISM has made valuable contributions to public safety.

For example, FDA was able to use the system to reassure the public that there was no link between an influenza vaccine and increased risk of febrile seizure in children (convulsion or seizure brought on by a fever). Another PRISM study comprising more than 1.4 million doses of Gardasil doses found no evidence of venous thromboembolism after vaccination among females 9 to 26 years old. FDA also used PRISM to identify a link between a rotavirus vaccine (RotaTeq) and an increased risk of intussusception in infants.

These case studies, along with other information, were discussed at a public meeting in December called to discuss what the system has accomplished and how it’s used in the regulatory process. The purpose of the workshop was to describe the Sentinel Initiative (a national electronic system for medical product safety surveillance) and the PRISM program, illustrate how FDA uses PRISM for regulatory responsibilities, and discuss the future direction of PRISM, including its further integration into the regulatory review process.

Stakeholders, including manufacturers, academics, the public, and other federal agencies, who participated in the workshop had an opportunity to weigh in with their opinions about the system, discuss its limitations, and offer ideas for improving it.

PRISM is one component of FDA’s Sentinel Initiative, which monitors the safety of a variety of FDA-regulated medical products by examining information in electronic healthcare databases.

Sentinel performs what is called “active” surveillance, as opposed to “passive” surveillance. Passive FDA surveillance systems depend on industry, consumers, patients, and healthcare professionals to recognize and report suspected adverse events to an FDA web site, such as the Vaccine Adverse Event Reporting System (VAERS). This means that FDA might not become aware of potential problems related to a licensed product for months.

Unlike passive surveillance, Sentinel’s active surveillance lets FDA initiate its own studies using existing electronic healthcare data in a timely manner. Sentinel also lets FDA evaluate safety issues in targeted groups, such as children, or to evaluate specific conditions (e.g., heart attacks) that are not usually reported as possible adverse events of medical products through passive reporting systems.

So by adding an active surveillance capability to FDA’s toolbox, Sentinel broadens FDA’s ability to monitor the safety of a spectrum of licensed medical products in support of the agency’s mission to protect and advance public health.

Azadeh Shoaibi, Ph.D., M.H.S., is the Sentinel Lead at FDA’s Center for Biologics Evaluation and Research

A Shocking “Exercize”

By: Suzanne Junod, Ph.D., and John Swann, Ph.D.

Suzanne Junod and John Swann

Suzanne Junod, Ph.D., and John Swann, Ph.D., holding FDA artifacts.

In this second installment of FDA’s new history video series, the FDA’s historians venture into the “vault” to explore the Relaxacizor, originally sold in beauty salons as a device that stimulated and relaxed muscles, but subsequently marketed as a passive exercise machine.

Ads for the device assured users that they would lose weight while building muscle mass, a promise that was, of course, too good to be true. FDA took legal action against the company and by the early 1960s succeeded in having the devices removed from the market.

Keep an eye out for the reference to the TV show, “Mad Men,” which included a faux advertising campaign for Relaxacizor in the show’s first season.

Enjoy your visit to the FDA History Vault.

If you missed it, watch the first video – an introduction to the series here.

Suzanne Junod, Ph.D., and John Swann, Ph.D., are FDA Historians.