The opioid epidemic has ravaged the United States, claiming hundreds of thousands of lives and leaving countless others grappling with addiction and devastation. At the heart of this crisis is OxyContin, a powerful prescription painkiller that was once marketed as a revolutionary solution for patients suffering from chronic pain. However, as the body count and amount of suffering from the drug continue to rise, questions have emerged regarding the role played by the U.S. Food and Drug Administration (FDA) in approving OxyContin for widespread use.

OxyContin was introduced to the market in 1996 by Purdue Pharma, and the drug was marketed as a groundbreaking pain reliever with a unique time-release formula that allowed for 12-hour pain relief. Purdue Pharma's aggressive marketing tactics led to the widespread prescription of OxyContin for a range of pain conditions, including moderate to severe pain. The promise of effective pain relief raised high hopes for patients and medical practitioners.

The FDA plays a crucial role in ensuring that pharmaceuticals are safe and effective before they reach the market. In the case of OxyContin, the approval process fell into the hands of FDA officer Curtis Wright. Wright joined the FDA in 1989 and by late 1996, had attained his maximum position as acting director of its Division of Anesthetic, Critical Care, and Addiction of Drug Products, which was responsible for protecting and promoting public health through the control and supervision of prescription pharmaceutical drugs. However, Wright was hesitant to approve OxyContin because critics argued that the clinical trials conducted for OxyContin did not adequately address the potential for abuse and addiction. Nevertheless, Purdue Pharma had already spent 30 million dollars on developing it, and if they did not get their drug approved, the company would soon go out of business; they needed the FDA to approve OxyContin by any means necessary. 

Based on Purdue documents cited in the investigation, Wright engaged in meetings with Purdue Pharma representatives held behind closed doors at a hotel near the FDA offices in Rockville, Maryland from January 31 to February 2, 1995. During these meetings, he permitted Purdue Pharma representatives to actively contribute to the drafting of his medical officer's review (MOR) of OxyContin, which included approving the wording of certain text to be used in OxyContin's package. Notably, the initial approved label for OxyContin included the statement, "Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.” This allowed the company a broader consumer base as the opioid could be marketed as less addictive, and therefore suitable for a wider range of patient pain than any previously FDA-approved opioids of similar strength.

OxyContin's approval marked the beginning of the opioid epidemic in the United States. By the early 2000s, it had become clear that OxyContin was being widely abused, as shown by deaths by overdose and a surge in opioid addiction cases. Purdue Pharma and its executives faced legal action for misleading marketing practices, ultimately declaring bankruptcy in 2019. 

While the FDA’s approval process is often seen as an objective and systematic way of testing drugs, OxyContin's approval serves as a haunting reminder of the critical need for enhanced scrutiny, transparency, and accountability in the pharmaceutical industry. Furthermore, Curtis Wright’s story is proof that the corruption and extortion of D.C. politics often have a profound impact on all Americans.

Information retrieved from the National Institutes of Health, Financial Times, Wikipedia, and Business Insider