Remarks by Stacy Amin to the DIA Advertising and Promotion Regulatory Affairs Conference March 1, 2019

Speech | In Person

• Speech by: Stacy Cline Amin

Remarks by Stacy Amin
Chief Counsel of the Food and Drug Administration
Drug Information Association
Advertising and Promotion Regulatory Affairs Conference

(Remarks as prepared for delivery)

Thank you for that kind introduction, Wayne, and thank you to DIA for inviting me to be here today.

I’m grateful to have the opportunity to talk about the important work the agency does to ensure medical product information is truthful, balanced, and accurately communicated—which is ultimately about ensuring medical products are used safely and with the greatest chance they will be effective. Before I do, I’d like to say a few words about what an honor it is to serve at the Food and Drug Administration, and to work alongside such a dynamic and passionate Commissioner.

Commissioner Gottlieb brings an energy and vision to FDA that is unmatched. I can say from personal experience that he cares deeply about the agency and its critical public health mission.

You had the pleasure of hearing from FDA’s Chief of Staff, Lauren Silvis, yesterday. Lauren works as hard as anyone I’ve ever served beside, and she bring the same energy and passion to the COS role that the Commissioner brings to the agency. We are fortunate to have Lauren’s leadership at FDA.

I also want to say what an honor it is to work with the rest of the Commissioner’s Office, the Centers, and to lead the brilliant and dedicated public servants in the Office of Chief Counsel. I’ve never before had the privilege of working with a group of people so talented and so dedicated to the singular purpose of improving and promoting public health. It’s a noble calling and so many people at FDA have dedicated their careers to it. Every day I think of how fortunate I am to work with the public servants at FDA.

I am also reminded every day of what an awesome—and I mean that in the traditional way—what an awesome responsibility we shoulder at FDA. We regulate a fifth of the U.S. economy and our work impacts every single person in this country. Everyone in this country eats food the FDA regulates, and everyone at some point in their lives will need medical products. I’m not sure there’s any other agency in the U.S. government that has such an immediate and significant impact on people’s lives.

The role of enforcement and compliance is particularly salient to the welfare of the public. We, the FDA and industry together, have a joint mission to ensure the safety of the food we eat and the medical products we use. That commitment to the public health is what brought me to the Chief Counsel job—the opportunity to work for a cause I believe in and to serve the public. And in my short time at FDA—I’ve been on the job less than 6 months—I’ve been impressed by the work I’ve seen and proud to be a part of it.

Since you’ve already heard from senior members of CDER, CBER, and CDRH, I’d like to focus the rest of my remarks by discussing a few areas they did not focus on: dietary supplements marketed as drugs, illegal opioid claims, e-cigarettes, and the agency’s guidance practices.

Dietary Supplements

On February 11, Commissioner Gottlieb announced a new plan to implement a significant modernization of dietary supplement regulation and oversight. That announcement was made against the backdrop of twelve warning letters and five online advisories to companies illegally marketing dietary supplements as unapproved new drugs.

The use of dietary supplements, such as vitamins, minerals or herbs, has become a routine part of the American lifestyle. Three out of every four American consumers take a dietary supplement on a regular basis. For older Americans, the rate rises to four in five. And one in three children take supplements, either given to them by their parents or, commonly in teens, taking them on their own.

In the 25 years since Congress passed the Dietary Supplement Health and Education Act (or “DSHEA,” as we call it), the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or more – different products available to consumers.

FDA believes that most players in this industry act responsibly. But as the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.

As part of our comprehensive efforts, in February we sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including Parkinson’s, heart disease, diabetes, and cancer. Products intended to treat Alzheimer’s and other diseases must gain FDA approval before they are sold in order to help ensure they are safe and effective for their intended medical use.

Three of the letters noted above were also sent in conjunction with the Federal Trade Commission (or the “FTC”). Specifically, FTC stated that the product advertisements claiming to treat Alzheimers and remediate or cure other serious illnesses may violate the FTC Act by making false or unsubstantiated health claims.

For example, one letter questions claims made for Melatonin supplements and three other supplements, which claim, “Many experiments have been conducted on this and it is proved that melatonin supplements are used to cure Alzheimer’s disease.”

Another letter identifies health claims made for five products, including one advertised as “[c]linically shown to help diseases of the brain such as Alzheimer’s and even dementia.” Other products claimed to treat or prevent some forms of cancer, Parkinson’s disease, human papilloma virus, and kidney stones, among others.

Another letter warns about claims for seven supplements that claim benefits for dementia, schizophrenia, Alzheimer’s, and Parkinson’s, among others.

Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer’s. Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions.

In recent years, we’ve also taken action against companies and dietary supplements making similar claims regarding treatment of serious conditions such as cancer and, as I’ll discuss next, opioid addiction.

Opioids

Tackling the opioid crisis continues to be a top priority for the agency and the administration. As part of its strategy to address this epidemic, FDA has pursued multiple compliance and enforcement efforts.

One area of particular concern is the illegal sale of prescription opioids online and through social media. Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. In many cases, products illegally marketed online as opioids are counterfeit drugs that can contain potentially lethal doses of illicit compounds like fentanyl.

In October 2018, as part of Operation Pangea XI, FDA sent warning letters to seven different networks that were operating a total of 465 websites offering misbranded and unapproved drugs to U.S. consumers, including four networks operating approximately 300 websites offering to illegally distribute opioids online. In addition, more than 450 domain names were brought to the attention of search engines and the appropriate domain name registries and registrars. This year’s Operation Pangea also took place at three of the nine international mail facilities in the U.S., as well as at other facilities around the world. Of the 626 packages examined, 794 products were refused entry into the U.S.

We have seen that entities can pose risk not only through direct unlawful sales of opioids, but also through the unlawful marketing of products with unsubstantiated claims to treat opioid use disorder and opioid addiction. This latter category of products have the potential to harm users based on known and unknown safety issues and based on the delay in use of legitimate treatments. As a result, FDA has focused new attention on such products. For example, in November, FDA issued warning letters to two companies whose products contained tianeptine, which has been associated with serious adverse events and which can have significant health effects.  Last May, FDA issued warning letters to three companies marketing kratom products with unapproved opioid cessation claims. And, last January, FDA and the FTC issued joint letters to the marketers and distributors of 12 different products marketed with unsubstantiated opioid cessation claims.

The agency will continue to monitor for companies engaged in this type of unlawful activity.

Tobacco

The agency’s work combatting the epidemic of youth addiction to e-cigarettes has been such a significant part of our work during my tenure, I’d be remiss if I didn’t discuss it here. And as many of you at this conference know, some of the most important court cases in FDA’s recent history have been in the tobacco space, including cases interpreting the First Amendment in the context of FDA regulation of tobacco marketing.

So, while this conference is focused on medical products, our work on tobacco matters can often be cutting-edge and impact all product areas the agency regulates.

For example, in 2012, the Sixth Circuit upheld the statutory provision that directs FDA to develop graphic health warnings for cigarettes, while the D.C. Circuit struck down FDA’s first attempt to do so. FDA has been actively engaged in the formidable task of developing a new proposal that appropriately accounts for the DC Circuit decision, while fulfilling our public health mandate to ensure the public is better informed of the health consequences of smoking.

Perhaps the most significant development in the last year has been FDA’s ongoing efforts to fight illegal sales of e-cigarettes to youth.

The FDA and the Centers for Disease Control recently published the 2018 National Youth Tobacco Survey showing astonishing increases in kids’ use of e-cigarette (or ENDS) products. From 2017 to 2018, there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students. Additionally, the data showed more than a quarter (27.7 percent) of high school current e-cigarette users are using the product regularly (on 20 or more days in the past month).

Secretary Azar has called this “a public health crisis that threatens an entire generation.” And Commissioner Gottlieb has pledged to use all available means to fight this epidemic of youth addiction to nicotine.

I’d like to highlight what I expect would be of most interest to this conference—our efforts to fight marketing that imperils youth.

In May 2018, FDA issued 17 warning letters, many in partnership with the FTC, for e-liquids with false or misleading advertising or labeling because they imitated kid-friendly food products, such as juice boxes, candies, and cookies. The products had names such as “One Mad Hit Juice Box,” “Candy King Sour Worms,” “Cookies and Milk,” “Twirly Pop,” and “Unicorn Cakes.” The products featured cartoon images and designs that resembled kids’ toys and popular kids’ food products. I’m happy to report that by August of 2018, all 17 of those products are no longer on the market with the misleading labeling and advertising.

FDA issued a similar warning letter in November to a company for selling e-liquids that resemble kid-friendly cereal, candy, and PB&J. These products follow a similar playbook as described above—the products feature cartoon characters that resemble the cartoon characters in popular children’s foods, like the Lucky Charms leprechaun and the Froot Loops toucan, and the packaging resembles food marketed to children. The company was also cited for illegally selling products to a minor, for failing to list its products with the FDA, and for selling e-liquids without the required FDA premarket authorization.

Nicotine in e-liquids is dangerous for children, and young children exposed to nicotine in e-liquids can experience severe harms such as death, seizure, and coma. FDA will continue to take vigorous actions to ensure these products are not marketed to children.

Guidances

Before concluding, I would also like to highlight some of the noteworthy guidances FDA has issued in the last year to help industry provide timely, accurate, and understandable information about medical products to consumers and to ensure industry has clarity regarding how FDA interprets its authorities:

• January 2019 -- Issued final guidance on labeling drugs and biological products approved under accelerated approval pathway
• October 2018 -- Issued draft guidance on Presenting Quantitative Information in Direct‐To‐Consumer Advertisements and Promotional Labeling for drug products
• September 2018 -- Issued final guidance on labeling of nonprescription drugs marketed without an approved application
• July 2018 -- Issued final guidance on labeling for biosimilar products
• July 2018 – Issued draft guidance on labeling indications and usage section of drugs and biological products
• June 2018 -- Issued final guidance on manufacturer communications with payors regarding drugs and devices
• June 2018 -- Issued final guidance on medical product communications that are consistent with FDA-approved labeling

This is an important topic because the executive branch’s use of guidance documents has been under scrutiny in recent years. FDA’s mission is not only to protect and promote the public health, but like all agencies in the federal government, we have a responsibility to use our enforcement authorities in a way that’s consistent with the rule of law.  I think of the “rule of law” as the principle that people should be governed by law and not by the arbitrary decisions of government officials. The rule of law allows people and businesses to know in advance what rules will govern them; it is not only about fairness but also about giving American industry a foundation of predictability and consistency to allow them to continue to innovate.

This Administration is committed to the rule of law, and one of the areas we’ve seen that is in the approach to guidance documents.  The Justice Department’s 2018 “Brand Memo” prohibits DOJ litigators from using agency guidance documents as a basis for proving violations of applicable law. The memo prohibits the use of agency guidance in a way that would effectively convert them into regulations, thereby making an end run around notice and comment rulemaking.

Earlier this week, the Solicitor General of the United States filed a brief with the Supreme Court arguing that significant limits should be put on the circumstances in which agency interpretations of ambiguous regulations, including those issued in guidance documents, should receive the heightened deference known by the courts as Auer, or sometimes Seminole Rock, deference.

I’m keenly aware of the scrutiny on agency guidance practices, and have made it part of my mission at FDA to ensure our guidances withstand that scrutiny. I have a practice of starting every briefing with one question—what does the statute say? I’m fortunate to have a team of disciplined lawyers that return to the text of the statute to ensure agency policy is always consistent with the law.

We also have a unique history with guidance documents at FDA—our governing statute contemplates the use of agency guidance documents in section 701(h) of the Act, and in many cases Congress actually writes into our statute instructions to the agency to issue guidance to the public.

Because of this unique history, FDA’s process for issuing guidances is in many ways a model of good practices. Pursuant to section 701(h), most FDA guidance documents are issued in draft form first to allow for a period of notice and comment before a guidance document is finalized. This is pursuant to section 701(h) and the Good Guidance Practices regulations FDA issued implementing that section, which require a notice and comment period and other procedural protections for many guidances. There is always room for improvement, but we believe our process promotes transparency and public participation in the process.

Guidance documents are important because they give industry notice of FDA’s regulatory policies, how FDA interprets its statutes and regulations, and where FDA intends to focus its finite enforcement resources. These guidance documents are not themselves binding—only the statute and the agency’s regulations can impose binding obligations. But non-binding guidance is an important component of the rule of law because it gives regulated parties notice of FDA’s policies and how FDA interprets its authorities.

Conclusion

In conclusion, I want to thank you for indulging me in a long speech. I’m so proud of the work FDA does and consider it the honor of a lifetime that I can be a part of it.

FDA continues to approve new medical products at a record pace, and we are very proud of that work as well. But our responsibility to appropriately assess the safety and effectiveness of these products goes hand in hand with the work that promotes innovation and consumer choice. I look forward to FDA’s continued, successful efforts in service of the public health. And I hope that industry will help to share and promote that mission.