If there is one thing people agree on in today’s world, it is that the United States is suffering from a severe opioid crisis. As addictions and overdoses continue to skyrocket, many researchers and others are searching not only for solutions to current problems, but also looking back to examine how the problem reached such epidemic proportions. Surprisingly to many experts, that answer may lie with the Food and Drug Administration, the very agency in charge of regulating and protecting consumers from these very dangers. As more research has been conducted, it appears as if the FDA unwittingly may have ignited the opioid crisis.
Based on the statements from certain individuals within the drug manufacturing industry, it is possible the FDA lit the fire for the opioid crisis in the United States by simply changing some wording on the packaging inserts found in Oxycontin. According to Ed Thompson, a high-ranking drug manufacturing executive who has recently come out against the practices of Big Pharma, the current crisis can be linked to when the popular opioid Oxycontin first appeared on the market in 1995. According to Mr. Thompson, when initially approved by the FDA, Oxycontin was approved only for short-term use. However, as its popularity increased, Big Pharma, doctors, and even patients lobbied for changes as to how the drug could be used.
Thus, in 2001, the FDA made what Mr. Thompson and others now look upon as the decision that may have opened the floodgates for the current opioid crisis by choosing to change the wording on the drug’s packaging insert to state Oxycontin was approved for daily, around-the-clock, long-term treatment. In doing so, Mr. Thompson alleges these changes were made illegally, since the drug never received formal FDA approval for use in this manner.
While changing only a few words on a label sounds harmless enough, Mr. Thompson states it is changes such as these that can have a significant impact on whether a drug manufacturing company can make $10 million on a drug or perhaps as much as $1 billion. Making this change allowed all drug manufacturers to market opioids in a much different fashion, leading doctors to prescribe larger numbers and doses of pills to patients much more frequently than in previous years.
Based on data provided by Mr. Thompson, the major problem with the label changes is the fact that there is no data to support the label’s recommendation that Oxycontin was ever safe for long-term use. To ensure something such as this cannot happen again, Mr. Thompson is now suing the FDA in federal court in an effort to force the agency to change its labeling and classification of opioids.
If the lawsuit is successful, it would set a new precedent, since drug manufacturers would then be forced to change their labeling and marketing of opioids. In doing so, Mr. Thompson estimates it would cost Big Pharma as much as $10 billion annually in sales and profits, which would greatly impact the industry.
According to addiction specialists such as Dr. Andrew Kolodny, who has acted as an expert witness against Big Pharma in numerous cases, the FDA’s decision to change the labeling on Oxycontin essentially set the stage for numerous patients to become drug addicts. However, the drug’s manufacturer, Purdue Pharma, continues to maintain that Oxycontin was approved for long-term use based on numerous clinical trials. Thus, as the debates and lawsuits play out over the coming months and years, everyone from Big Pharma executives and manufacturers to doctors and patients will wait to see what decisions are made by the courts.
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