Source: United States Department of Justice Criminal Division
Thank you, Maya, for that introduction and to the Food and Drug Law Institute for inviting me to open the Enforcement, Litigation and Compliance conference today. It’s an honor to be here with colleagues, from both government and industry, to discuss the accomplishments of the Justice Department’s Consumer Protection Branch.
I am proud to represent the more than 120 attorneys and staff of the branch that work each day to protect Americans’ health, safety, economic security and identity integrity and to obtain justice for those harmed by unlawful products or practices.
We do not do this work alone. The branch works closely with lawyers and investigators from the Food and Drug Administration (FDA), Federal Trade Commission and Offices of Inspectors General from around the federal government, as well as our colleagues at FBI, Drug Enforcement Administration, Bureau of Alcohol, Tobacco, Firearms & Explosives (ATF), U.S. Marshals Service (USMS), U.S. Postal Inspection Service and Homeland Security Investigations (HSI), among others. Working alongside these partners, as well as the Justice Department’s 94 U.S. Attorneys’ Offices, the branch brings civil and criminal enforcement actions to hold accountable those who threaten the safety of Americans.
A large part of this work involves partnering with public health agencies like FDA to enforce laws relating to the regulation of products, including tobacco, food, medical devices, pharmaceuticals and dietary supplements.
Among other actions, the branch pursues civil or criminal actions against:
- those who fail to maintain sanitary facilities or distribute tainted food products;
- drug and medical device manufacturers who sell adulterated and misbranded products;
- fraudsters who sell fake cures or counterfeit drugs; and
- clinical research personnel who fabricate or falsify clinical trial data in ways that can adversely impact FDA’s drug approval decisions.
Driving this work is the steadfast belief that the medical and scientific judgments of FDA’s experts should be respected. Every day, millions of Americans rely upon FDA’s expertise when consuming food, taking prescription drugs, or using medical devices. The branch is dedicated to ensuring that these consumers can have faith that the products they are using or the medicines they are taking are being marketed and sold to them, and to their medical professionals, consistent with the science and with the law.
I’d like to spend a minute talking about a few recent developments from the past year that highlight this principle. In May of this year, a federal court sentenced Endo Health Solutions for violating the Food, Drug and Cosmetics Act (FDCA) in the distribution of its opioid medication Opana ER with INTAC. The sentence included over $1.5 billion in fines and forfeiture, the second-largest set of criminal financial penalties ever levied against a pharmaceutical company. The sentence followed a guilty plea in which the company admitted that its sales representatives marketed Opana ER by touting its purported drug abuse deterrence and crush resistance despite a lack of clinical data supporting these claims. The truth was that rather than deter opioid abuse, the proliferation of Opana ER and other similar drugs fueled the Nation’s opioid crisis. The consequences were devastating for millions of families across the country. The branch will continue to prioritize investigating and prosecuting drug manufacturers who, like Endo, went beyond the science to boost their profits.
Another area where the branch is committed to ensuring that FDA’s medical judgment is heeded is the sale, distribution, and marketing of electronic nicotine delivery systems, or ENDS — commonly known as e-cigarettes or vapes. According to the most recent National Youth Tobacco Survey, nearly 6% of middle and high school students — about 1.63 million children — report using e-cigarettes. Though this is a significant decline from pre-pandemic numbers, the number of children putting their health at risk with these products remains far too high; of the students who report using, more than one-third reported using e-cigarettes regularly and more than one-fourth did so on a daily basis.
We know that many of these e-cigarette products are specifically designed to attract underage users. The Youth Survey indicated that more than 87% of students who use e-cigarettes, use flavored products such as candy or fruit flavored varieties. And e-cigarettes are now being designed to allow users to play video games, receive text messages or even play music — much like a smartphone — in order to maximize their appeal to youth.
To date, FDA has approved only 34 vaping products, and yet many companies continue to distribute or sell unauthorized products in violation of FDCA requirements. In addition, the Prevent All Cigarette Trafficking (PACT) Act requires tobacco sellers, including e-cigarette sellers, to comport with certain reporting, registration, packaging and delivery requirements, including requiring proof of age at the time of delivery. But many online retailers ignore this requirement and put youth at risk as a result. The branch is currently working with U.S. Attorneys’ Offices across the country to help stop the distribution of illegal e-cigarettes.
But we know this fight is too big to go it alone. So last summer, the department and FDA launched a multi-agency task force to combat the illegal distribution and sale of e-cigarettes. Members of the task force include the ATF, USMS, Postal Inspection Service, HSI and Customs and Border Patrol (CBP), among others. Recently, our colleagues at CBP and FDA announced the result of an operation in which they seized nearly 3 million unauthorized e-cigarette products at the border worth about $76 million. And this fall, the Task Force met with members from offices of 15 different state attorneys general as well as the leadership of the National Association of Attorneys General to discuss ways we could collaborate, and amplify each others’ efforts to stop unauthorized tobacco vaping devices from being sold and distributed.
Our commitment to ensuring respect for FDA’s medical and scientific expertise extends beyond enforcement to our work defending suits challenging the agency’s actions. One notable example has been a set of cases seeking to displace FDA’s judgment regarding the medical abortion drug mifepristone. In the leading case, Alliance for Hippocratic Medicine vs. FDA, the plaintiffs sought, among other remedies, to set aside FDA’s initial approval of the drug, an approval first granted more than two decades ago. Earlier this year, the Supreme Court held that the plaintiffs in Alliance lacked standing, and the case was remanded back to the District Court. Alliance, and a few other cases also involving mifepristone, remain pending. In each of them, the Consumer Protection Branch — in collaboration with our colleagues in the Federal Programs Branch, Civil Appellate, and the Office of the Solicitor General — has argued that FDA’s decisions are grounded in the relevant medical and scientific data. And we will continue to emphasize that the law and the facts require courts to defer to, and not countermand, FDA’s expert scientific judgment that mifepristone is safe and effective.
The mifepristone cases are not the only examples of the branch’s commitment to defending FDA’s medical and scientific expertise this past year. In October, in Jazz Pharmaceuticals v. Becerra, the branch successfully defended FDA’s judgment that a particular narcolepsy drug was “clinically superior” to another drug and thus qualified for approval under the terms of the Orphan Drug Act. This past summer, in Ipsen Biopharmaceuticals v. Becerra, a unanimous panel of the D.C. Circuit affirmed FDA’s determination that a medicine used to treat certain hormonal disorders was a “drug” regulated under the FDCA, rather than a “biologic” subject to the Public Health Service Act. And in Novartis Pharmaceuticals v. Becerra, the branch persuaded the district court to reject a challenge to FDA’s approval of a so-called “skinny label” for the generic version of Novartis’s heart failure drug Entresto. In its opinion granting the branch’s motion for summary judgment, the district court expressly recognized the common thread that runs through each of these cases: judicial review of FDA’s judgment must be “limited” so that courts are not “unduly second guess[ing]” the agency’s “scientific judgments.”
I want to turn now to another principle that guides our work: the commitment to holding accountable companies and individuals who put particularly vulnerable Americans at risk by not meeting their obligations under our nation’s public health and safety laws. Our recent action against Family Dollar Stores represents perhaps one of the most notable recent examples of our work to hold accountable a company failing to abide by its public health obligations. Family Dollar Stores pleaded guilty last February in the Eastern District of Arkansas to violating the FDCA by holding food, drugs, medical devices, and cosmetics under insanitary conditions. As outlined in the plea, in August 2020, the company began receiving reports of mouse and pest issues with products being shipped from an Arkansas distribution center to 400 different stores across six states. Despite these reports, the company continued to ship from the Arkansas warehouse for another year-and-a-half when an FDA inspection revealed live rodents, dead and decaying rodents, rodent feces, urine, and evidence of gnawing and nesting throughout the facility. As a result of its guilty plea, Family Dollar Stores agreed to pay fines and forfeiture of $41.675 million — the largest ever in a food safety case.
The branch and its agency partners have also recently held accountable companies and executives who fail to ensure the safety of medical devices. In April, we secured a consent decree resolving a complaint against Philips RS and some of its executives for manufacturing and distributing sleep and respiratory devices — including CPAP and BiPAP machines — in violation of FDCA requirements. This resolution followed a 2021 recall due to foam used in many of the devices that could degrade and be inhaled by the machines’ users. Thanks to the consent decree, Philips agreed to cease production of its devices at its three Pennsylvania facilities, with some limited exceptions, until the company has completed a set of specific measures designed to ensure their safety going forward.
The branch also actively pursues medical professionals who betray their patients and the public trust by violating federal public health and safety laws. In April, the branch secured the conviction at trial of a Dallas anesthesiologist for tampering with consumer products and intentional adulteration of a drug. The defendant, Raynaldo Riviera Ortiz Jr., surreptitiously injected the stimulant epinephrine and other drugs into IV bags of saline that he knew were going to be used in his colleagues’ surgeries. In just one summer, numerous patients at the facility where the defendant worked suffered cardiac emergencies as a result of Ortiz’s crimes. Another anesthesiologist died while treating herself for dehydration with an IV bag. Last month, a court sentenced the defendant to 190 years’ imprisonment for his crimes. I am incredibly proud of the lawyers and agents who worked tirelessly to ensure that Ortiz never hurts another patient.
As the Deputy Assistant Attorney General for the Consumer Protection Branch, I have the privilege of working alongside the dedicated career attorneys and staff who commit themselves to protecting Americans from consumer threats.
I am incredibly proud of the work they have done over the past year to tirelessly defend FDA’s medical and scientific judgments, and to hold accountable those who ignore those judgments.
I am fortunate to call them my colleagues, and the American people are fortunate for their continued service.