- Speech by
Deputy Commissioner for Policy, Legislation, and International Affairs - Food and Drug Administration ( March 2019 - January 2021 )
(Remarks as prepared for delivery)
Good morning. Thank you for that kind introduction.
As some of you may know, I’m the Deputy Commissioner for Policy, Legislation, and International Affairs at FDA. I began my tenure at FDA in 2017 after years of working on health care policy on the Hill and at the White House.
FDA is a very special place. It is a strong agency with a vital public health mission.
I am truly humbled to be able to serve alongside my FDA colleagues on behalf of patients and the public. I am constantly impressed with the agency’s world-class workforce made up of scientists, doctors, lawyers, policy makers, communicators, and so many others.
And so, it is a special pleasure to represent the FDA at this important conference spotlighting such a critical health issue.
Today, allergies are a growing public health and safety concern that affects millions of Americans. While more robust prevalence estimates of clinically confirmed food allergies in the US population are still needed, a 2010 NIH clinical food allergy guidelines found an overall population prevalence of about three percent, but recent studies have suggested a higher prevalence rate, with a rate as high as eight percent in children.
A gathering such as this one, which brings together a diverse group of scientists, policy makers, doctors, chefs, health and safety advocates, public figures such as athletes, developers and entrepreneurs, members of the media, and many others can play a very important role in advancing the ball forward in this important public health area.
It offers the opportunity to share the latest research and ideas, to focus on, and discuss opportunities for, supporting research into causes and cures, and to address the broad range of challenges that are part and parcel of the symptoms and treatment of allergens.
These challenges can and do, of course, include the physical manifestations of an allergic response, which can range from very mild to very severe.
But they also include an impact on individuals with allergies and their families that is sometimes overlooked, and that is the emotional and psychological toll.
That impact can, for instance, include undefined fears relating to the possibility of severe anaphylactic episodes. It can include questions of independence and security, particularly relating to children with allergies.
It can involve social challenges concerning the isolation and even resentment that children with allergies can experience in school and other group environments. This is also a challenge for those who run schools, day care centers, and other educational environments. According to the Centers for Disease Control and Prevention (CDC), 1 in 13 children—roughly two in every classroom—has food allergies. These institutions need to be prepared to support children who may face such challenges.
It should come as no surprise that the FDA -- as a science-based, consumer-focused agency with the mission to protect and promote the public health -- is very focused on this serious issue.
Our engagement covers a variety of areas, incorporating the different authorities and responsibilities we have. These can include conducting and analyzing scientific research necessary to study and approve new treatments, soliciting public input on proposed treatments, ensuring the availability and accessibility of existing treatments, developing and validating analytical methods to detect allergens and other harmful substances in products, and enforcing the law related to mislabeling of foods and other products to ensure the safety of consumers.
I’d like to talk about some of FDA’s work in several of these areas by bringing together our scientific expertise, our ability to disseminate information to the public, and our focus on consumer protection.
While most food allergies lead to relatively minor or mild symptoms, the greater risk and concern comes from those allergic reactions that can cause severe, and sometimes even life-threatening conditions.
To this end – in part because there currently is no cure for food allergies -- one of the most important strategies to help prevent serious health consequences is through strict avoidance of food allergens, combined with early recognition and management of allergic reactions to food.
The FDA plays a key role in this activity, through our responsibility for, and oversight of, proper labeling of food allergens in products. As the law makes clear (and is designed to prevent), food allergens present, but not declared on a product’s label may pose a potentially serious health risk.
The Federal Food, Drug, and Cosmetic Act requires that a food containing a major food allergen declare the source of the allergen. Major food allergens include any of the following: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
Although we don’t have the authority from Congress to alter the number of major food allergens, we can require some labeling of other food allergens so we regularly evaluate the potential that other food allergens may rise to this level and pose a risk to U.S. consumers.
The FDA also has the authority, in appropriate circumstances, to issue regulations requiring the disclosure of spices, flavorings, colorings and incidental additives that are, or contain, allergens other than these eight major food allergens.
Last year, the FDA issued a request for information on the prevalence and severity of sesame allergies in the United States. This was designed to inform next steps regarding sesame as an allergen, including possible labeling on packaged foods.
Currently, sesame is not required to be disclosed as an allergen, and in some circumstances, sesame may be exempt from being listed by name in the ingredient statement on food packages, for example, as part of a spice blend.
In addition to issuing these kinds of requests for information, the FDA regularly monitors the scientific literature and consumer complaint databases to identify emerging food allergen concerns and determine whether possible agency action is warranted.
Our goal in all of this – any action we might take on the classification or regulation of any product – is to ensure to the best of our ability the product knowledge and personal safety of any consumer who purchases a food product for consumption.
We are aware that some food labels are not as reliable as they should be. In fact, undeclared allergens on labels are the leading cause of food recalls requested by the FDA. This year there have already been 21 voluntary recalls for “tree nuts” alone.
To reduce the number of these recalls ... and the corresponding danger from these products … the FDA works on several fronts.
We conduct food facility inspections that include elements specific to food allergens as part of the examination of the firms’ adherence to Current Good Manufacturing Practices, the preventive controls that a factory puts in place, and requirements for labeling of the major food allergens. When necessary, we work with firms on recalls of products with undeclared major food allergens.
In addition, we regularly research the causes of manufacturing errors, and work with industry on best practices, and developing new ways to test for the presence of allergens.
One important piece of this effort is the role played by consumers themselves. It’s essential that when consumers experience a food allergy reaction they report them to the FDA consumer complaint coordinator, through our website. This will help FDA in determining which foods are the most affected, which allergens are the most prevalent, and how the labeling errors that led to the incident actually occurred.
We know, for instance, that the allergens most often involved in recalls are milk, wheat and soy. And the five food types most involved are bakery products, snack foods, candy, dairy products and dressings. For consumers who are interested, they can monitor on the FDA’s website which products have been recalled most frequently.
It’s also important that we understand why these recalls occur. Our research has shown several issues relating to either the use of the wrong label for products that are sold in packages that look similar, or as a result of new printing technologies that may reduce costs but also can lead to increased labeling errors. We continue to review more recent data, which may show other or additional reasons.
To address these challenges, we’re working with industry to raise awareness in understanding these labeling issues and to support them in efforts to make what can often be simple changes in handling, packaging and labeling. Those changes can make such a difference in the lives of every one of the millions of consumers with food allergies.
As we work to ensure that foods are properly labeled so that consumers are adequately informed and protected, we’re also engaged in efforts to fulfill the enormous promise offered by science.
As I mentioned, the FDA is a science-based agency. And a core focus of our mission is to transform today’s extraordinary scientific advances into new effective approaches, treatments, and cures.
One of the most promising approaches we are examining in terms of the treatment of food allergies is the clinical development of Allergen Immunotherapies. Our engagement in this work is strong and growing.
In our Center for Biologics Evaluation and Research (CBER for short) we now have four clinical reviewers committed to the review of allergenic products, and an entire laboratory devoted to investigating and testing products for the diagnosis and treatment of allergic disease that are based on this science. That lab is also creating a new senior leadership position for basic or translational research on food allergy.
And, I should point out that to further support this work, CBER communicates closely and regularly with our Center for Food Safety and Applied Nutrition (CFSAN) on a variety of issues relating to allergens.
Currently, scientists and reviewers in CBER are looking at two types of immunotherapy treatments.
I’m sure many of you are aware of Peanut Allergen Powder, manufactured by Aimmune Therapeutics. This powder was indicated for treatment to reduce the risk of anayphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy.
The objective is to develop immune treatments that return the individual to the normal tolerance for foreign food proteins – and raise the threshold for an accidental dose of peanut at which allergic reactions occur.
For those of you who are unfamiliar with this investigational treatment, the peanut flour is carefully prepared and supplied in capsules to be sprinkled onto a person’s food of choice. The dosing starts very low and is increased over a period of a few months. Once a person begins to take it, they must stay on it.
This past September we held a meeting of the FDA’s Allergenic Products Advisory Committee to examine and make recommendations on the safety and efficacy of this product. Some of you may have participated in this meeting. If so, I thank you for your input.
These developments in the immunotherapy world are very exciting. If approved, the product would be the first immunotherapy for any food allergy.
While this development could be a very important one – and I caution that it has not been approved – it’s also important to keep in mind, as with all allergen immunotherapy, that this product does not achieve tolerance of peanuts.
To this end, we also must recognize that children who are on the path to being protected from unexpected exposure to peanuts are being purposely exposed to it. So, while the ultimate result can have the important and significant effect of reducing the risk of accidental death from accidental exposure to small amounts of peanut, there are risks involved in the building up to the maintenance dose, even during the maintenance dose to allergic reactions caused by the product. These reactions can occur even in the most controlled situations.
That’s why it’s so important, should this treatment be approved, that the prescriptive regimen be closely followed and that auto-injectable epinephrine be available throughout the treatment course.
Research and development in this area is very exciting and heading in the right direction -- the prevention of peanut allergies or a complete cure of peanut allergy.
The bottom line is that we are living and working in very exciting and very promising times. And there is reason to hope that we will be able to advance more and better treatments for peanut allergies in the coming years.
Of course, immunotherapy is not the only field of science in which we see exciting advances taking place. We (as well as many developers) are looking at a variety of new ideas and technologies to support the development of innovative treatments.
For example, some scientists and developers are studying new biotechnologies that allow the use of genetic engineering or genome editing to either eliminate or lower allergens in plants and animals that are used to produce food. The goal of these efforts is, for example, to produce a hypoallergenic peanut or a wheat that has low levels of gliadin, a component of gluten.
For although genetic engineering poses exciting possibilities and potential, we must remember that some of this work is with respect to allergens is still in the earliest stages of exploration and will need more research.
Before I close I want to spend a few minutes talking about another very important role that the FDA plays in supporting the prevention and treatment of allergic reactions – ensuring the availability of essential life-saving treatments for allergic reactions.
Many people rely on epinephrine to treat life-threatening reactions to bee stings, certain foods, or other allergens. According to the Journal of Asthma and Allergy, approximately 5 to 7.5 percent of people will experience severe reactions to insect stings in their lifetime, and for them, epinephrine can be a life-saver.
In recent years we’ve seen a shortage of EpiPen, the vehicle for administering this treatment. Though there is currently no shortage, this remains a top priority for the FDA.
We understand that families and communities who face limited availability of this important product due to a disruption in supply may experience serious challenges.
That’s why manufacturers are required to report information about shortages to FDA, which we post on our website. And we monitor shortages through this and other means, including patient reporting and collaboration with the American Society of Health-System Pharmacists.
We also provide information to health care providers and patients that there are alternative epinephrine auto-injector products that can be used safely and effectively, and our Drug Shortages webpage includes a list of these products that are available from other manufacturers including their contact information.
In August of last year, the FDA approved the first generic version of EpiPen and EpiPen Jr auto-injector. This approval means patients living with severe allergies who require constant access to lifesaving epinephrine should have another approved product to help protect against potential drug shortages.
We also support efforts by manufacturers, to provide additional treatment options when drug shortages exist.
I hope you have gathered from this brief survey that the FDA is working on several fronts to address some of the most significant challenges surrounding reactions to allergens consistent with our vital mission to protect and promote public health.
As this organization understands well, the answers will not come from any one place, but from different sources.
They will come from the entrepreneurs and investors, and developers who provide additional new funding for research.
They will come from government agencies and the research, scrutiny, and oversight of new treatments and of existing products, as well as from the communication with, and education of the public on these issues.
And they will come from those individuals who themselves suffer from allergies, and their loved ones who are also impacted, and who play such a critical role in supporting the gathering and dissemination of statistics, information, and innovation.
It is a collaborative effort, and FDA looks forward to working with all of you as we move forward in this field to new successes on behalf of the millions of Americans impacted by food allergies.