In supporting its claim that America faces an opioid epidemic, the Centers for Disease Control and Prevention (CDC) stated in 2014 that:
In 2009, some 15,500 Americans died from opioid overdoses, a 300% increase over the previous 20-year period (and that figure has risen every year since). For each of those 2009 deaths, there were an additional ten treatment admissions, 32 emergency department visits, and 825 nonmedical users of these drugs. Opioid users also die from improper drug interactions and other causes. In 2012, healthcare providers wrote 259 million prescriptions for painkillers — or more than one painkiller prescription for every single adult living in the U.S.[vi]
The obvious question is how did America become “addicted” to a class of drugs that originally was meant to be helpful to persons suffering with chronic intense pain, such as nerve pain and pain caused by cancer, and not persons suffering from arthritis and other such common ailments. The answer, of course, has many facets, but one of the more evident issues concerns the marketing of these drugs by the pharmaceutical companies that manufacture them.
While the pharmaceutical industry is highly-regulated in many ways,[vii] laws and regulations concerning marketing and other practices relating to the distribution of opioids is a mishmash of silence, statutory law and regulatory law at both the state and federal levels, and governmental guidelines and policy pronouncements that do not have the force or effect of law. In addition, lawsuits concerning opioid sales can be filed by state attorneys general, state and federal agencies, and other political subdivisions. Finally, criminal actions sometimes are instituted by various prosecuting authorities against current and former employees of pharmaceutical companies accused of criminally promoting opioids.
“Silence” means the absence of law governing specific behaviors; in other words, where a behavior is not prohibited, it is permitted. But while the behavior may be in that sense permitted, it would not necessarily be a wise course of action, the situation thus potentially resulting in self-regulation. While the pharmaceutical industry indicates in various ways that it engages in serious self-regulation,[viii] the evidence is mounting that, in the case of opioids at least, too little meaningful or significant self-regulation is occurring.[ix]
At the federal level, the Food & Drug Administration (FDA) has regulatory authority concerning the advertising and promotion of prescription drugs. The FDA’s authority is based on a number of federal laws, including the Food, Drug, and Cosmetic Act (FDCA), which, inter alia, addresses prescription drug advertising. It requires that advertisements for prescription drugs be accurate and not misleading. The FDA’s authority begins once an advertisement becomes public. If the FDA objects, it sends a letter to the drug maker asking it to pull the advertisement. If the dispute is not resolved at that level, it can escalate to a lawsuit using the relevant sections of the FDCA as the basis for formally complaining about the content of the advertisement.[x]
In addition to the FDA, the CDC now plays a role in trying to stem the opioid crisis. In March, 2016, the CDC released the 2016 Guideline for Prescribing Opioids for Chronic Pain (the Guideline). The Guideline, which is voluminous, set forth 12 recommendations for determining when to initiate or continue opioids for chronic pain. As a guideline, it does not carry the force or effect of law but the underlying idea is that the pharmaceutical industry should pay close attention to it lest the Guideline become a formal part of the federal statutory or regulatory framework.[xi]
And it isn’t just the drug makers who face governmental scrutiny. The wholesale distributors of opioids have faced civil actions from the Drug Enforcement Administration (DEA) in recent years. In 2008, the DEA, along with six states, sued McKesson, the nation’s largest drug wholesaler, for supplying hundreds of suspicious hydrocodone orders to rogue pharmacies. McKesson settled, paying more than $13 million in fines and agreeing to closely monitor its pill supply. In later actions, the wholesaler ultimately paid $150 million in fines and had distribution centers suspend operations in four states, but “a civil penalty of a few million dollars or tens of million dollars means nothing when you’re making potentially billions of dollars,” a former DEA official explained. In 2016, the state of West Virginia sued McKesson. Discovery in the case has revealed that, in a five-year period, the wholesaler delivered nearly 100 million doses of opioids in a state with a total population of 1.8 million people. The suit alleges that “while West Virginia was drowning in painkillers, McKesson continued to incentivize sales...with bonuses for the sale of oxycodone and hydrocodone.”[xii]
At the state level, most if not all of the states currently have some form of consumer protection act. These laws are enforced by the Attorney General (and/or district attorneys) of each state. Similar to the FDCA, consumer protection laws prohibit deceptive practices aimed at consumers, including false and misleading advertising.
In July, 2014, “[a]ttorneys for Santa Clara and Orange counties…filed a complaint on behalf of the People of the State of California alleging that five of the largest opioid manufacturers — Purdue Pharma, Cephalon, Janssen Pharmaceuticals, Endo Health Solutions and Actavis — deceived physicians and patients alike by exaggerating the effectiveness of opioids for the treatment of long-term, non-cancer pain and withholding information regarding the dangerous, addictive effects of the drugs. The complaint claimed that there is no reliable scientific evidence for the benefits of opioids in this regard and that the pharmaceutical companies were deliberately deceptive in order to increase their profits. As a result, according to the [suit], a rise in opioid addiction has led to a myriad of deleterious social effects in California.”[xiii]
“Pfizer, the world’s second-largest drug maker, [recently] agreed to adhere to strict standards for marketing and promoting prescription opioids to treat common chronic pain conditions, such as arthritis and back pain. The company made the agreement with the City of Chicago, which [had] sued five other opioid manufacturers over alleged misleading marketing of opioids. Pfizer [had not been] named in the lawsuit.”[xiv]In the criminal sphere, prosecutors are weighing in. For example, “[t]he arrests of two former pharmaceutical salesmen for allegedly paying doctors to prescribe fentanyl, the powerful painkiller that caused pop singer Prince’s fatal overdose, drew a strong reaction from law enforcement and some doctors, who note that pharmaceutical companies have aggressively marketed risky and addictive painkillers in recent years and have paid more than $1 billion to settle charges of illegal marketing. Fentanyl is the most powerful of all opioids and can be up to 100 times more potent than morphine.”[xv]Clearly, there is a huge problem. Equally clearly, the answer to the problem is not so clear. In a titanic clash of capitalism, differing opinions concerning the nature of opioids and the effect they are having on Americans, and differing views of responsibility, law should bridge the gap. To some extent, it is likely that the law is inadequate in some areas, and even where the law may be forceful as written, it may not be adequately enforced or even in some cases enforceable. With demand for opioids at an all-time high, the problem grows.The responsibility of the industry is to follow the law — in letter and in spirit. And while some would argue that the industry’s responsibility ends with its legal responsibility, others would argue that profit should be sublimated to humanity if non-legal responsibility is to mean anything.
[ii] Dina Gusovsky, “Americans Consume Vast Majority of World’s Opioids,” CNBC, April 27, 2016, http://www.cnbc.com/2016/04/27/americans-consume-almost-all-of-the-global-opioid-supply.html
[iv] Meredith Tracey, “Five Pharmaceutical Companies Sued in Response to Opioid Addiction Epidemic,” PM360, The Essential Resource for Pharma Marketers, July 15, 2014, quoting a CDC publication, https://www.pm360online.com/five-pharmaceutical-companies-sued-in-response-to-opioid-addiction-epidemic/
[vi] FDA’s Efforts to Address the Misuse and Abuse of Opioids, Feb. 6, 2013, https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337852.htm
[vii] Dr. N.M. Graham Dukes, The Law & Ethics of the Pharmaceutical Industry, Elsevier Science, 2005, https://www.elsevier.com/books/the-law-and-ethics-of-the-pharmaceutical-industry/dukes/978-0-444-51868-2
[viii] Brandan Shaw and Paige Whitney, “Ethics and Compliance in Global Pharmaceutical Industry Marketing and Promotion: The Role of the IFPMA and Self-Regulation,” 18 Pharmaceuticals Policy and Law 199 (2016), http://www.ifpma.org/wp-content/uploads/2016/11/17.-Ethical-Business-Practices.pdf
[ix] http://fox2now.com/2017/03/29/sen-claire-mccaskill-launches-federal-probe-of-opioid-industry/ and http://www.cnn.com/2017/03/28/health/senate-opioid-manufacturer-investigation/index.html
[xii] Jim Axelrod & Ashley Velie, CBS News, May 25, 2016, http://www.cbsnews.com/news/drug-distributor-mckesson-faces-lawsuit-in-effort-to-stem-opioid-painkiller-epidemic/
[xiii] Supra, Note iv.
[xiv] “Doctors, Drug Companies Responsible for Opioid Crisis,” Partnership for Drug-Free Kids, July 13, 2016, http://drugfree.org/learn/drug-and-alcohol-news/doctors-drug-companies-responsible-opioid-crisis-drug-policy-director/
[xv] Liz Szabo, “Drug Salesmen Arrested for Paying Doctors to Prescribe Fentanyl,” USA Today, June 15, 2016, http://www.usatoday.com/story/news/2016/06/15/drug-salesmen-arrested-paying-doctors-prescribe-fentanyl/85803100/
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