Purdue Reformulates OxyContin as "Abuse-Deterrent" After 14 Years, Drives Users to Heroin

On April 5, 2010, the FDA approved Purdue Pharma’s reformulated OxyContin designed to make it more difficult to crush, snort, or inject—14 years after the original drug’s launch and three years after the company’s guilty plea to criminal misbranding. Purdue ceased shipping the old formulation on August 5, 2010, and began exclusively shipping the reformulated version on August 9, 2010.

Too Late: Epidemic Already Established

The reformulation came far too late to prevent the opioid epidemic. By 2010, millions of Americans were already addicted to prescription opioids. OxyContin had been aggressively marketed based on false addiction claims since 1996, and Purdue had pleaded guilty to criminal misbranding in 2007. The 14-year delay between launch and reformulation allowed widespread addiction to take hold across the United States.

Unintended Catastrophic Consequences

When Purdue reformulated OxyContin to make it “abuse-deterrent,” the change had disastrous unintended public health impacts. The reformulation accelerated a nationwide spike in heroin use and hepatitis C infections as opioid users switched to injecting illicit heroin after 2010.

In states with above-average OxyContin use, hepatitis C infection rates increased 222 percent after 2010. Separate studies showed the OxyContin reformulation also drove a spike in heroin-related deaths. The reformulation essentially pushed addicted Americans from prescription opioids to more dangerous street drugs, worsening rather than improving the crisis.

Questionable Effectiveness

A decade after the reformulation, U.S. health officials found insufficient evidence to show an overall benefit. Fatal overdoses involving prescription opioids including OxyContin, Percocet, and generic pills rose more than 30 percent to about 14,500 in 2017—seven years after the supposedly “abuse-deterrent” formulation was introduced.

Patent Extension Scheme

The reformulation served Purdue’s financial interests regardless of public health impact. The patent on original OxyContin would have expired in 2013, opening the market to generic competition. By reformulating the drug, Purdue extended its patent until 2030. Since 2010, OxyContin has generated more than $21 billion in U.S. sales, demonstrating that the reformulation was primarily a business strategy disguised as a public health measure.

Regulatory Failure

The FDA’s approval of the reformulated OxyContin as “abuse-deterrent” without requiring evidence of actual reduction in abuse or overdose deaths represents another regulatory failure. The agency allowed Purdue to market the new formulation’s supposed safety benefits without long-term studies proving effectiveness, repeating the same pattern of inadequate scrutiny that enabled the original OxyContin approval in 1995.

This case demonstrates how “reforms” implemented years too late, without adequate evidence, and serving corporate patent extension strategies can actually worsen public health crises while generating billions in continued profits for pharmaceutical companies responsible for the original harm.