FDA weighs OxyContin patent decision

April 15, 2013 at 4:54 PM
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WASHINGTON, April 15 (UPI) -- The U.S. Food and Drug Administration is weighing whether or not a dangerous painkiller would serve the public's interest, experts said.

On Tuesday, the original patent for the painkiller OxyContin expires, The Wall Street Journal reported.

But the painkiller is widely known to be frequently abused, as it can be crushed and then smoked, snorted or ingested, which circumvents the time-release components, making for a strong, opioid-like high, the newspaper said.

Because of the abuse problems, Purdue Pharma LP, which owns the patent for the painkiller, developed a formula that is much harder to crush, which serves as a deterrent.

This puts the FDA between a rock and a hard place. If it allows the generic companies to produce the painkiller in its original, easy-to-abuse form -- a painkiller with $2.8 billion in annual sales -- it will be allowing millions more people in pain access to effective pain relief at a much lower cost. It currently costs $7.60 per pill or $450 per prescription. A generic version would be up to 40 percent cheaper than the brand name version, RBC Capital Markets pharmaceutical industry analyst Shibani Malhotra said.

On the other hand, Purdue's patent for the abuse deterrent version does not expire until 2025. That means, the FDA could be serving the public's need for cheaper pain medicine while making a dangerous drug more affordable at the same time.

The issue pits a profit-oriented company, politicians and addiction counselors against generic drug companies, which have a track record of helping make important blockbuster drugs cheaper.

"It's going to mean more dead kids," Jeffrey Reynolds, executive director of the Long Island Council on Alcoholism and Drug Dependence told the Journal.

Rep. Hal Rogers, R-Ky., co-chairman of the Congressional Prescription Drug Abuse Caucus, said the FDA would face "consequences" if it did not make the right call.

"Purdue does not think that the public safety will be served by an influx of opioids from multiple sources that do not employ abuse-deterrent technology," company spokesman James Heins said.

On the other hand, banning the more crushable version of the drug would mean "leaving behind the millions of patients who stand to benefit from access to lower-cost versions" of OxyContin, said David Gaugh, a senior vice president at the Generic Pharmaceuticals Association.

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