FDA Says No To Generic OxyContin
April 17, 2013 by UPI - United Press International, Inc.
WASHINGTON (UPI) — The U.S. Food and Drug Administration said generic drug companies may not produce the patent-expired version OxyContin due to its use as a street drug.
The decision could be considered groundbreaking since it is the first time the FDA has ruled a tamper-resistant version of a narcotic drug trumped the health benefits of a cheaper product that more patients could afford, the FDA’s Dr. Douglas Throckmorton said.
Had the FDA approved the production of a generic OxyContin, it would have been allowing companies to produce a drug with a decade-long track record of abuse.
OxyContin was first produced in 1995 by Purdue Pharma under the expectation its time-release properties would make it safe.
But it was quickly discovered that crushing the pill allowed abusers several choices for ingestion that were dangerous and addicting, The New York Times reported Wednesday.
Purdue then developed a form of the pill that turns into a jelly-like goo when crushed. But that gave rise to accusations drug companies will wait until the last minute to introduce tamper-proof versions of their blockbuster drugs to extend their monopolies.
The patent for OxyContin in its original form expired Tuesday. The patent for the tamper-proof version does not expire until 2025.