Remarks at the FDLI Enforcement, Litigation, and Compliance Conference
December 5, 2017
Remarks by Rebecca K. Wood
Chief Counsel, FDA
FDLI Enforcement, Litigation, and Compliance Conference
Wednesday, December 6, 2017
I’m delighted to be here with you at FDLI’s Enforcement, Litigation, and Compliance Conference to talk about some of the important work we have been doing during my first months at FDA—as well as some key priorities as we look forward.
It is a privilege to work closely with such a dynamic Commissioner who is tireless in his efforts to advance FDA’s public health mission, to partner with leadership in the Centers and the Office of Regulatory Affairs as they tackle novel and complex public health challenges and opportunities, and to lead the incredibly talented and dedicated lawyers in the Office of Chief Counsel at FDA.
In his seven months at FDA, Commissioner Gottlieb has made significant progress across a number of important public health areas, including efforts: (1) to combat addiction to opioids and nicotine; (2) to bring enhanced innovation and competition to the market to enable more access to prescription drugs; (3) to empower consumers to make more informed decisions about their health and diet; (4) to strengthen regulatory science and efficient, risk-based decision-making to enhance food and medical product safety and to protect consumers; and (5) to recover from natural disasters—including the effects of the hurricane in Puerto Rico that has, in addition to the devastating effects on the local population including many FDA employees, had an outsized impact on the production of critical medical products.
FDA makes hard decisions every day in deciding how to best use its resources to protect the public health. Part of that consideration takes into account the danger particular products and practices pose to a great number of people. FDA aims to use its enforcement tools to focus on those parts of the industry that pose the greatest public health risk to the greatest number of people because of a failure to comport with manufacturing, labeling, sanitation, or approval standards.
I want to focus first this morning on several enforcement areas that have garnered particular attention in recent months at FDA. Confronting the addiction crises threatening the health of American communities and families has been a key focus at FDA. Indeed, the Commissioner has made issues related to opioid addiction his top priority since coming to FDA. And he has expressed significant concern about the risks associated with the growing trade in illicit and often synthetic opioids, such as fentanyl, that we see entering the United States. We know that the synthetic opioid drug market is constantly evolving and growing, and it has been a challenge to track and to enforce against it. Many illicit drugs are entering our country through the global postal system and reach our country through International Mail Facilities. FDA has been working to increase staffing in these facilities and to improve our ability to inspect packages that are suspected to contain illicit drugs. And FDA has been working with federal and international partners to enhance a number of enforcement efforts.
For example, FDA has worked in partnership with international regulatory and law enforcement agencies to obtain convictions against a former police officer and pharmacist who operated online pharmacies illegally importing unapproved drugs, including opioids, to American consumers. More generally, we know that many foreign, unapproved drugs are purchased from online pharmacies and distributed through the mails. Combating the unlawful sale and distribution of foreign, unapproved, and counterfeit drugs remains a significant task for the agency to help ensure that Americans have access to safe and effective medical products that do what they are supposed to do.
In the area of compounding, FDA is devoting significant effort to enforcement, particularly in the setting of sterile drugs that are compounded without adequate safeguards and under insanitary conditions. As you know, compounded drugs can be critically important to patients, but they also can pose serious risks. Significant patient harm can be caused when there is contamination in drugs that are meant to be sterile because they are being introduced into the spine, the bloodstream, or the eye. 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 our oversight and enforcement in this space, including through implementation of the Drug Quality and Security Act (DQSA) of 2013. Consistent with a risk-based approach, FDA is working to prioritize inspections of larger-scale pharmacies that ship compounded drugs across multiple state lines, where breakdowns in sanitation and manufacturing practices can have serious and broad public health implications. We are partnering 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, there have been multiple, notable consent decrees in this area in recent months. One such case, for example, alleged that a pharmacy compounded purportedly sterile injectable and ophthalmic drugs under insanitary conditions. The consent decree prohibits the firm from processing or distributing drugs until it comes into compliance.
FDA also has been particularly focused on enforcement against those who would attempt to deceive or to take advantage of vulnerable patients with unsupported claims. As a cancer-survivor himself, Dr. Gottlieb has spoken out against firms that “deliberatively prey on sick people with baseless claims that their substance can shrink or cure cancer.”
Such claims can be particularly worrisome from a public health perspective in emerging areas where the agency wants to encourage a science-based approach to developing new technologies and treatments. In this vein, the Commissioner has spoken about one of the most promising new fields of science and medicine being the use of cell therapies in regenerative medicine—and the corresponding danger of unsupported drug claims in this setting. The field of regenerative medicine holds great promise for transformative and even curative treatments across a range of vexing medical conditions that touch so many American families, including cancer, diabetes, and Parkinson’s disease. Medical advances have created a real opportunity for the development of clinically important and life changing treatments. At the same time, FDA has noted the danger of unscrupulous and unsubstantiated claims in this setting. In recent months, for example, FDA has announced several actions against stem cell clinics that fail to comply with federal law. This includes a recent seizure action with respect to five vials of Vaccinia Virus Vaccine (Live)—a vaccine reserved for people at high risk of smallpox, such as some members of the military—that was being used by clinics to create an unapproved stem cell product that was injected intravenously and directly into the tumors of patients with cancer. Another action involved issuing a warning letter to a firm that was administering a stem cell product intravenously or directly into the spinal cord of patients to treat a range of serious diseases including Parkinson’s disease and ALS, and was failing to follow written procedures designed to mitigate the risk of microbiological contamination of sterile products and the attendant risk of patient infection. These kinds of actions underscore the importance of a science-based approach to claims and compliance with appropriate product development processes.
Another FDA enforcement priority has been to target practices that put vulnerable populations, such as children, at heightened risk of harm. In the context of tobacco, for example, FDA has focused on vigorously enforcing the law that makes it illegal to sell tobacco products to kids and is exploring 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 kids—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.
In the medical diagnostics setting, FDA has issued a health alert and warning letter against a firm for marketing lead testing kits that may provide inaccurate results, giving falsely low test results. Lead poisoning, of course, can be particularly dangerous for infants and young children.
In the food context, FDA has taken action to stop the sale of products where the facility is contaminated with listeria, a pathogenic bacterium that can cause listeriosis, a rare but potentially life-threatening illness. People with compromised immune systems, the elderly, pregnant women, and developing babies can be most susceptible to listeriosis. Whole genome sequencing technology can link isolates of bacterial pathogens in the environment and a food source or a person who became ill from eating contaminated food. In several recent actions, for example, the court entered a consent decree of permanent injunction precluding the defendant from preparing, processing or packing FDA-regulated food products until they show that their facility equipment and sanitation controls are suitable to prevent future listeria contamination. In addition, FDA is making use of its administrative detention and food facility registration tools to take swift action to intervene and prevent potential outbreaks of food-borne illnesses.
As FDA continues to review a risk-based approach to enforcement actions, I anticipate that we will see additional actions across a range of circumstances where regulated entities are attempting to deceive or take advantage of vulnerable populations or placing patients and consumers at significant risk of harm.
Finally, I want to touch on an enforcement area that has received some significant interest over the years. Questions have long been raised about the possibility of what some have called “vicarious” criminal liability in the setting of FDA-regulated products. The issue is often framed as whether it is possible that a person’s liberty could be put in jeopardy where that person did not personally commit a wrongdoing. In other words, in what circumstances if any should FDA pursue what some have called “strict liability” crimes where apex personnel could be held not only civilly responsible, but also criminally responsible, for serious acts or omissions done by subordinates at their firm? Is it possible to clarify further the circumstances in which a legal obligation stems from the duties and responsibilities—to seek out and correct or prevent violations—assumed by the individuals themselves. In this regard, we are exploring whether, consistent with the agency’s risk-based approach and public health mission, there are additional ways that we can bring added clarity to this issue. For example, are there ways, we could make clearer the circumstances in which criminal charges should be pursued against an individual in a supervisory role? And could we clarify, consistent with the requirements of Due Process and the special public health risks inherent in many FDA-regulated products, whether a breach of a duty to act or to correct violations must occur before criminal charges should be brought? These are important questions that we will be carefully considering.
In closing, we know that we stand at an important inflection point for the agency and for public health. There is unbounded potential for extraordinary, life-saving and life-enhancing public health developments. And FDA’s enforcement efforts will play an important role in checking unlawful conduct that diminishes that progress and poses serious risk to patients and consumers.
We know that we have the finest Food and Drug Law Bar, many of whom are assembled here, to help regulated entities conform their conduct to lawful requirements and to help foster this historic progress. Thank you for your time and it has been a pleasure talking with you this morning.