This is not your father's FDA.
Oxycontin Approval, 1995
Much has been made of Purdue Pharma's "aggressive marketing campaign" for OxyContin as a reason for the explosion of OxyContin sales following its introduction. It was Purdue and its officers that were found guilty of a felony.
But what was the impact on prescribing physicians of the initial FDA product labeling information for OxyContin?
That labeling stated, "Delayed absorption, as provided by OxyContin tablets is believed to reduce the abuse liability of a drug.”
Remember, physicians had lagged behind the recommendation of medical authorities that chronic non-cancer pain should be treated more aggressively. There was increasing pressure to treat pain with opioids, but physician concerns about addiction retarded use of opioids.
The FDA statement provided a strong endorsement for what physicians were looking for: a new, safer drug they could more comfortably prescribe to pain patients.
OxyContin Abuse Begins.
By 2000, reports came in to Purdue Pharma that OxyContin tablets were being ground into a fine powder in order to defeat the controlled release feature, and then taken nonmedically.
Quickly these reports turned into a new OxyContin reality.
Congressional hearings were held in Dec., 2001, and Feb., 2002.
FDA Response to OxyContin Abuse
If this was the FDA of the thalidomide era, OxyContin would have been withdrawn from the market.
But that's the past, not the new FDA.
In July, 2001, the FDA changed the labeling of OxyContin, removing the phrase about "reduced abuse liability."
The FDA also initiated work on a risk management plan.
The FDA also committed to developing guidance on risk management plans by 2004.
How effective were the FDA's actions?
The FDA's actions were useless in stemming the tide of prescription opioid abuse and prescription opioid deaths.
Subsequent to the FDA actions, the number of past year nonmedical users of OxyContin increased each year until 2010, when the abuse-deterrent formulation of OxyContin entered the market.
From 1999-2001, the number of prescription opioid overdose deaths increased from 4,041 to 5,538.
From 2001-2010, the number of prescription opioid overdose deaths increased each year, from 5,538 in 2001 to 16,651 in 2010.