Rebecca K. Wood, FDA Chief Counsel
FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
Good afternoon. It is a pleasure to be with you this afternoon at FDLI’s Annual Conference to talk about some of the key matters on our radar.
This conference has always been a forum for those who care about food and drug law to gather together and to discuss some of the most novel and complex legal issues facing our bar.
Indeed, our office is continually impressed by the high caliber of legal analysis we see from the food and drug bar, and—even when we do not ultimately agree with it—that quality is immensely helpful to our own thinking as we strive to provide the highest quality of legal advice to the agency.
I have served as Chief Counsel at FDA since last July. Over the better part of the last year, it has been a privilege to work closely with the Commissioner and Center leadership to provide legal counsel as the agency tackles some of the most challenging public health matters facing our agency and our nation.
Each day, I am extraordinarily grateful for the encyclopedic knowledge, practical wisdom, and good humor of my wonderful colleagues in the Office of Chief Counsel. I am deeply honored to lead this thoughtful and collegial group of lawyers. Our work load is vast, demanding, and growing, and we are all benefitted by the extraordinary depth of expertise and judgment of the lawyers in our office.
As you may know, our office is composed of about 160 people. In general, we divide ourselves into counselors and litigators. Our counselors tend to specialize in the work of a given Center—drugs, biologics, veterinary medicine, cosmetics, medical devices, tobacco products, food, and so on. Many of our lawyers also have cross-cutting knowledge which proves invaluable as we strive to discern the ways in which an interpretation of the law in one setting may reverberate into another. We provide legal advice on the day-to-day legal matters facing the agency: statutes, regulations, Good Guidance Practices, individual party matters, enforcement matters. We frequently partner with our clients early on as they explore innovative approaches to problem solving.
Our litigators work closely with the Department of Justice to defend litigation, to bring litigation, and to respond to inquiries. On many occasions, our litigators will partner with our counselors to assess potential litigation vulnerabilities of a potential course of action, to press whether a course of action is supportable, and to help our clients assess options and pathways that may accomplish important public health goals with less legal risk. And our counselors frequently provide essential perspective and analysis as our litigators navigate a particular legal action.
Our office strives to provide high-caliber legal analysis on complex constitutional issues. For example, our First Amendment Working Group meets regularly to analyze important First Amendment considerations across a variety of agency actions and matters, as these considerations arise in a range of regulatory and litigation settings. We are working hard to ensure that recent First Amendment developments in the courts are fully imprinted across the DNA of our office and our agency.
And we are continuing to develop cross-cutting expertise in our office to further enhance the advice we give regarding important matters of administrative law across our portfolio. We know that agency actions have significant interest, and we are working hard to build additional scaffolding around our analysis of these important structural issues. We also know the important role that appropriately cabined agency guidance documents can play in providing transparency, predictability, and a measure of granularity in highly technical areas that Congress has entrusted to an expert agency’s judgment.
As you no doubt could tell from his remarks this morning, Commissioner Gottlieb is incredibly devoted to advancing the agency’s public health mission and to pioneering innovative solutions to vexing public health challenges. Those of us who work closely with him have taken to measuring our time together in dog years—Dr. Gottlieb inevitably accomplishes more in a day than most people do all week. He brings a personal intensity and devotion, as a doctor, as a cancer survivor, as a husband and father to everything he does that is truly inspiring. He challenges all of us to re-think tired old patterns of analysis, and to imagine a better solution, a third way, a new way of thinking about the biggest challenges we face as an agency.
I want to focus my remarks this afternoon on several areas that are receiving considerable attention in our office.
One of the most important priorities for our agency has been eloquently addressed by our leadership: the opioids crisis confronting so many communities and families in our country. FDA has an important role to play in helping to solve this problem. And our office provides legal counsel across many fronts, including on the issuance of warning letters to companies who would unlawfully distribute opioids in violation of the FD&C Act, and pioneering innovative approaches to encouraging enhanced prescribing and packaging practices to reduce opioid addiction.
In the area of innovation and enforcement, our office has been focused on a variety of important legal issues. We know that we stand at an important pivot point for the agency and for public health. There is vast potential for the expansion of life-saving and life-enhancing public health developments. And FDA frequently has an important role to play in encouraging the free exchange of truthful and non-misleading information, while also checking unlawful conduct that poses serious risk to patients and consumers. As a litigator, my approach to enforcement matters naturally focuses on ensuring that we are adequately explaining, and building an appropriate record for, the matters the agency elects to pursue.
I have previously remarked on FDA’s approach to enforcement matters. As you know, FDA makes challenging decisions each day about how to use its resources to best protect the public health. That analysis takes into consideration the danger particular products and practices pose. FDA aims to use its enforcement tools wisely to focus on those matters that pose the greatest public health risk because of a failure to comport with manufacturing, labeling, sanitation, or approval standards.
A significant FDA enforcement priority has been targeting practices that put vulnerable populations, such as children, at heightened risk of harm.
In the setting of tobacco products, FDA has focused on enforcing provisions that make it illegal to sell tobacco products to kids and FDA continues to look for ways to make tobacco experimentation less attractive to children. FDA has previously announced that it is investigating ways to make tobacco products less toxic, less appealing, and less addictive when it comes to youth—such as exploring potential limitations on flavors and marketing that appeal to youth, child-resistant packaging, and product labeling to prevent accidental, unintended exposure by children to liquid nicotine.
Earlier this week, FDA and FTC announced a joint effort to send more than a dozen warning letters to the makers of certain e-cigarette liquid nicotine products that resemble children’s juice boxes, candy, and cookies. As these warning letters vividly illustrate, the products at issue closely resemble kid-focused products and contain imagery that misleads children into thinking that the product is appropriate to eat or drink. For example, one such product closely resembles a child’s apple juice box in its appearance and aroma. Another such product mimics candy, and even includes a lollipop along with the nicotine liquid. These marketing tactics are particularly concerning to FDA because even small amounts of liquid nicotine, if accidentally ingested, can be toxic to children.
So, while FDA is fully committed to exploring the important role that appropriately marketed novel nicotine products may play in encouraging adults to migrate from potentially riskier combustible products, special care must also be taken to ensure that these products are not targeting children, or leading to accidental ingestion by children with tragic consequences.
Our enforcement efforts also include continued vigilance in the important area of compounding. FDA continues to place particular focus on circumstances in which drugs that are intended to be sterile are compounded without adequate safeguards and under insanitary conditions. Compounded drugs can, of course, be critically important for patient care. But significant patient harm can be caused if there is contamination in injectable drugs that are meant to be sterile.
As you know, in 2012, the United States experienced a serious outbreak associated with compounded drugs that were contaminated, causing hundreds of patients to experience fungal infections, and resulting in dozens of reported deaths. Since that time, FDA has devoted significant effort to strengthening oversight and enforcement in this space, including through implementation of DQSA, the Drug Quality and Security Act of 2013.
Consistent with its risk-based approach, FDA is working to prioritize inspections of larger-scale facilities that ship compounded drugs across multiple state lines, where problems with sanitation and manufacturing practices can have particularly serious and widespread implications for public health.
We are working closely with the Department of Justice to bring enforcement actions against compounders that put patients at risk by failing to produce sterile drugs in compliance with the law.
For example, in the last two weeks, we announced the entry of a consent decree of permanent injunction against a 503B outsourcing facility. As alleged in the complaint, this compounder was manufacturing and distributing injectable drugs that were adulterated under the FD&C Act because they were made under insanitary conditions and in violation of current good manufacturing practice (CGMP) requirements. Under the terms of the consent decree, the compounder must cease operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure compliance with the FD&C Act and CGMP requirements.
FDA entered into a consent decree several months ago with another compounding pharmacy. In that matter, the complaint alleged that a pharmacy compounded purportedly sterile injectable and ophthalmic drugs under insanitary conditions. That consent decree also prohibits the firm from processing or distributing drugs until it comes into compliance.
These are but two recent examples of FDA’s continued oversight of practices in compounding facilities.
I want to touch also on the important role of preemption and preclusion in our work. We know that there are a number of circumstances that raise important questions about whether a party’s compliance with federal standards means that state law on the same matter must yield. One way in which this can arise is when Congress has reserved a particular issue to a federal agency, and a regulated entity has taken steps to ensure compliance with those federal standards. In that circumstance, what role does the Supremacy Clause play in preventing conflicting state actions?
In recent months, the agency has had occasion to file amicus briefs in multiple circumstances where its perspective may be helpful to a court navigating whether federal regulation fully addressed the matter at hand or left space for additional state law action. And we continue to consider other circumstances in which it may be appropriate for the agency to provide the benefit of its views and scientific conclusions to the relevant state agency or court.
For example, there may be circumstances in which state-law efforts to urge warnings with respect to a given matter—for example, that a particular substance causes cancer—will stand in sharp tension with the agency’s scientific judgment to the contrary or desire to take a risk-based, rather than a hazards-based, approach to regulation. We are actively evaluating multiple circumstances in which the agency’s voice may be helpful to the appropriate resolution of such matters.
In addition, we also carefully scrutinize circumstances in which it may be appropriate for the agency to assert its prerogatives to exercise statutory primacy in a particular matter. For example, we have had occasion in recent months to file a statement of interest and amicus brief in a matter in which a private party asked another agency—in this case, the International Trade Commission—to open a proceeding to determine a threshold question of FD&C Act law: namely, whether the product at issue should be regulated as a drug or dietary supplement where FDA itself had yet to make such a determination. And, in another recent matter, we had occasion to address whether a bankruptcy court, rather than an Article III court, was an appropriate forum in which to adjudicate public health questions regarding whether a regulated entity should be enjoined from marketing drugs that violate the FD&C Act.
In these types of circumstances, FDA carefully considers whether action is needed to properly support and protect the statutory prerogatives that Congress has entrusted the agency with exercising as the expert federal agency.
We know that the intersection of the First Amendment and FDA’s authorities is properly an area of sustained interest and perennial importance. As I have said before, there can be no question—especially following the United States Supreme Court’s decision in Sorrell, and myriad lower court decisions, including Caronia—that the First Amendment has a significant role to play in the agency’s regulatory work. Indeed, it is difficult to have a discussion in this area today without due consideration for the role of constitutionally protected speech.
We know there can at times be tension between the key public health mandates that Congress has entrusted to FDA and the imperatives of the First Amendment. For example, FDA’s imprimatur of safety and efficacy creates a gold standard of excellence that promotes robust research and development and gives confidence to doctors and patients that there is a high standard of scientific rigor behind the drugs that FDA has approved. And the First Amendment recognizes a critical role for the robust discussion of truthful and non-misleading scientific and medical information, and a measure of breathing room for such discussions. The extent to which the First Amendment requires a safe harbor for such information—even in the absence of FDA approval—presents important questions that the agency and the courts continue to wrestle with.
FDA’s cross-cutting First Amendment Working Group, led by senior career professionals, continues to take a hard look at many of these important and difficult issues across the many First Amendment issues that arise at the agency. Among the issues being considered are: Is there more that the agency should do to refresh its regulations to reflect the courts’ modern approach to the First Amendment and to bring additional certainty to its work? Can the agency do more through guidances published pursuant to the Agency’s Good Guidance Practices to enhance transparency on these issues? Can the agency improve training to equip those charged with carrying out its public health mission to identify and consider First Amendment issues with lasting and flexible tools to identify and address these important considerations? These are key questions that we continue to study closely.
For example, as FDA has previously noted, we have been working hard on these issues and look forward to taking actions that will address important issues in this space.
First, as to intended use, FDA published a final rule in March to delay the effective date of amendments to the intended use regulations that had originally published in January 2017. These regulations describe how the agency determines the “intended use” of medical products, a foundational concept in food and drug law. FDA previously announced that it took this action to allow more time for FDA to consider the feedback received, to make sure that our approach is guided by our public health mandate, and to ensure the clarity of our rules on the subject. The agency anticipates additional work on this important matter.
Second, FDA has previously announced a number of anticipated guidance documents that articulate FDA’s current thinking on manufacturer communications about their products. There has been great interest, for example, in the parameters of a firm’s communications about health care economic information (so-called HCEI) with payors, formulary committees, and similar entities. What effect does Section 114 of FDAMA, the amendments under the 21st Century Cures Act, and the overlay of recent First Amendment jurisprudence have on Section 502(a) of the FD&C Act? What is FDA’s recommendation about how firms should communicate HCEI with payors, formulary committees, and the like regarding prescription drugs—particularly in light of the sophistication and built-in skepticism of that audience? We anticipate having more to say on this important matter.
There has also been great interest in the parameters of a firm’s communications with respect to data and information about the approved or cleared uses of their products that are not contained in their products’ FDA-required labeling. How does FDA determine whether a firm’s product communication is consistent with the product’s FDA-required labeling, and how does FDA evaluate whether the communication is misleading?
In sum, we look forward to continuing to work with the FDA bar as we unpack these important and challenging questions.