A new report by researchers at Johns Hopkins University shows that the Food and Drug Administration (FDA) failed to adequately address the opioid epidemic that has caused enormous suffering throughout the United States. The documents show the FDA failed to appropriately conduct oversight of the pharmaceutical industry and did not adequately train doctors to handle opioids and the associated risk of addiction. These failures contributed to the rise of opioid addiction in the United States, which kills around 72,000 people per year.
The report concerns the FDA’s efforts, beginning in 2012, to address the opioid crisis and reduce the rate of addiction and overdose. The Risk Evaluation and Management Strategy (REMS) they created to try to address the opioid crisis was meant to make opioid manufacturers train doctors in the appropriate use of their products. It was also intended to make those manufacturers conduct oversight to ensure the training was followed and report back on the results they found.
The central issue, however, is that the FDA allowed manufacturers to create their own training without input or oversight from government authorities. Additionally, these training programs were considered voluntary, not mandatory, meaning many doctors didn’t go through what meager training programs did exist. The result is inadequate training across the board that fails to properly address the risks of opioid dependency, where that training was even conducted at all. The FDA responded to the report, noting that the REMS was just a part of its overall response to the opioid crisis, but that is little comfort to those who have suffered with the consequences of opioid addiction.
If you or someone you know has become addicted to prescription painkillers or has suffered injury or died from an accidental overdose, you may be entitled to compensation for your pain and suffering. Seeking the advice from an attorney experienced in medical malpractice and products liability will help assure you get the compensation you deserve. The lawyers at Levine and Slavit, PLLC assist clients in collecting the damages they need to cope with opioid addiction. For more information or to schedule a consultation with our New York medical malpractice or products liability lawyers, call (888) LAW-8088 or fill out our contact form.