FDA Mandates Further Research from Drug Makers Into Long-Term Effectiveness of Opioids

Opioids were responsible for over 47,000 overdose deaths in 2017, according to the Center for Disease Control and Prevention (CDC). Over one-third of those deaths involved medications obtained with a prescription. Doctors often prescribe opioids for pain management, but the use of opioids for long-term management has reportedly never received adequate scientific review. In February 2019, the U.S. Food and Drug Administration (FDA) directed drug companies that manufacture approved opioid pain medications to conduct further research on their long-term use. This directive came after widespread criticism of the agency regarding its handling of the opioid epidemic. Manufacturers of well-known prescription opioids have also faced extensive criticism for allegedly pressuring the FDA to modify drug labels and inserts to allow expanded marketing and prescribing.

The term “opioid” refers to a class of drugs used in pain management. It includes illegal drugs like heroin, as well as controlled substances that are available for medical use like morphine, codeine, oxycodone, and hydrocodone. Opioids are different from opiates, in the sense that while opiates are derived from naturally-occurring chemicals in the opium poppy, “opioid” describes any substance that binds with opioid receptors in the human body. It therefore includes synthetic compounds like fentanyl.

Heroin is classified as a Schedule I controlled substance under federal law, meaning that the federal government has determined that it has “a high potential for abuse,” “no currently accepted medical use,” and “a lack of accepted safety for use…under medical supervision.” Numerous other opiates and opium derivatives, including certain forms of codeine and morphine, are also listed in Schedule I. Other opiates and opioids are listed in Schedule II, which allows for medical use. These include fentanyl and substances that are “chemically equivalent or identical with” substances listed in Schedule I, such as oxycodone.

Much of the controversy surrounding prescription opioids involves OxyContin, a brand name for oxycodone. In 2001, the FDA changed the labeling requirements for OxyContin to indicate use of the drug when “around-the-clock opioid analgesic is needed for an extended period of time.” Critics contend that this allowed vastly expanded marketing of the drug, contributing significantly to opioid addiction and overdose deaths. The FDA’s original approval for the drug, according to a former FDA commissioner, was based on scientific research showing it to be effective only for short-term use.

A lawsuit filed last year, Pharm. Manuf. Research Svcs. v. FDA, challenged the entire basis for the FDA’s decisions about labeling of OxyContin and other opioids. The plaintiff was a drug manufacturer who had submitted a new drug application (NDA) for an opioid painkiller. The main point of the lawsuit was to compel a hearing after the FDA denied the NDA. The court dismissed the complaint for lack of jurisdiction in January 2019, but the case brought attention to the issue. The plaintiff’s president went on the show 60 Minutes in February to discuss concerns about opioid labeling. The FDA issued its research directive shortly afterwards, although it is not clear whether the negative publicity from the 60 Minutes appearance played a role in that decision.

If you or a loved one or friend has suffered injuries because of a dangerous or defective medication, the experienced New York injury attorneys at the Law Offices of Mark A. Siesel are available to help. Please contact us online or at 914-428-7386 today to schedule a free consultation to discuss your legal rights and options.