U.S. Face Opioid Epidemic. By now, it is well known that the United States is facing an opioid epidemic. Thousands of individuals—many of whom have had legal prescriptions for opioids—have lost their lives to opioid overdoses. A recent article from Lexology explores the matter further and analyzes many of the legal issues that stem from the opioid crisis.
First, a few facts about the opioid problem in the United States:
- A few irresponsible doctors in the medical field are disproportionately liable for prescribing opioids.
- Most opioid overdoses are due to mixing drugs.
- In those who take their opioids exactly as prescribed, the annual addiction rate falls between 1 and 2 percent.
- In nearly 25 percent of drug-related malpractice claims, medical mistakes that involve opioids are cited.
- Those who abuse opioids are likely to suffer mental illness, mood disorders, and depression.
- Those who have a history of illegal drug use are more likely to misuse opioids.
Off-label Use of Prescription Drugs
When a drug is not used for its original purpose, it is called “off-label use.” The off-label use of substances is completely legal according to the Federal Food, Drug, and Cosmetic Act, or FDCA. The FDCA is a group of laws that provides authority to the United States Food and Drug Administration (FDA) to supervise the safety of drugs, food, and cosmetics.
The FDA does not have the authority to stop doctors from prescribing drugs that have been approved by the FDA—including opioids—for an appropriate course of treatment. This is true regardless of whether the indication is printed on the substance’s FDA-approved labels and pamphlets.
The United States Supreme Court has even held that “‘off-label usage…is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”
However, surely there must be some limitations on physicians’ ability to prescribe off-label uses—if the FDCA legalizes off-label uses, how is it regulated?
Each state has its own medical boards and agencies that regulate the practice of medicine. In one United States Supreme Court case, Barsky v. Bd. of Regents, the court held, “It is elemental that a state has broad power to establish and enforce standards of conduct within its borders relative to the health of everyone there. It is a vital part of a state’s police power. The state’s discretion in that field extends naturally to the regulation of all professions concerned with health.”
Further, in Goldfarb v. Virginia State Bar, the United States Supreme Court concluded, “We recognize that the States have a compelling interest in the practice of professions within their boundaries, and that as a part of their power to protect the public health, safety, and other valid interests they have broad power to establish standards for licensing practitioners and regulating the practice of professions.”
Numerous Other Courts Have Reached Similar Conclusions
In general, these rules govern the use of controlled substances, including opioids. However, the states have not interfered much with a physician’s ability to prescribe a drug for off-label uses. The states have interfered in only a few instances, including matters that involve diet drugs, performance-enhancing substances in athletics, and abortion.
Lawsuits Filed by States Against Drug Manufacturers: A Hypocritical Move?
Many states have resolved claims with drug manufacturers after accusing them of perpetuating the opioid crisis. Others remain entangled in contested litigation with these companies. Several states have also filed claims against wholesalers and other individuals in the line of the sale of opioid substances.
These claims involve drugs that were approved by the FDA. They were prescribed by licensed physicians and were filled by licensed pharmacists. Where were the states when this was happening? As declared by the United States Supreme Court, the states can ban off-label uses of certain drugs, such as opioids, but they have chosen not to.
The off-label use of opioids is allowed under state law. If certain states are concerned that off-label uses of prescription opioids are too dangerous for consumers, they can make these uses illegal. If the FDA has approved certain uses for certain drugs, that is different—the states would be unable to make such uses illegal because they are trumped by federal law. However, when the FDA has not approved a specific use of a specific drug, the states are free to prohibit it if they wish.
Some legal scholars argue that such a lack of action on the part of the states could result in a claim of failure to mitigate damages in a lawsuit. Drug manufacturers and others accused of harming the public with the off-label use of opioid substances could respond to these lawsuits and argue that the states never outlawed off-label uses; therefore, they should not be able to pursue claims against the defendants for the same actions.
In a New England Journal of Medicine article, the authors wrote, “the risk-benefit profile of opioids used for chronic pain remains unknown” because “no studies lasting longer than 1 year…evaluated pain, function, or quality of life as a primary outcome.” If this is true, it may be some time before the FDA approves opioids for long-term use. To gain such approval, drug manufacturers generally must provide “results from two well-designed clinical trials.”
The FDA has also stated that the use of analgesics in most pediatric patients is also an off-label use. Along with the long-term use of opioids, pediatric use could also be another area where the states could step in and regulate off-label use of opioids.
Other Agencies Are Cracking Down on the Use of Opioids
The Drug Enforcement Administration (DEA) has shared that it would be watching physicians in matters involving opioids. In an alert from the Academy of Integrative Pain Management from November of 2017, the authors said:
“The Drug Enforcement Administration has recently taken criminal and administrative action against physicians who prescribed transmucosal immediate-release fentanyl (TIRF) off-label for the treatment of breakthrough pain. Historically, prescribing medications off-label has been a decision left to the discretion of the prescriber based on the specific needs of the patient; therefore, physicians prescribing these products off-label for non-cancer breakthrough pain should be aware of this increased scrutiny.”
However, it is ultimately up to the states to regulate their own medical doctors. If the states are convinced that opioids are a danger to society—and there is much evidence that suggests this is the case—then they need to step up and take action. The states should not just sit back and file lawsuits over events that they are well within their ability to prevent.
Thousands of individuals will die this year after overdosing on opioids that they legally obtained from their physicians. If the United States wants to see these numbers decline, then proper steps must be taken to curb the improper use of these substances. Otherwise, the number of opioid-related deaths may continue to increase.