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FDA urges drug companies to make a safer pain killer

Dan Gorenstein Jan 29, 2013

FDA urges drug companies to make a safer pain killer

Dan Gorenstein Jan 29, 2013

The Food and Drug Administration has a prescription painkiller epidemic on its hands. More than 16,000 people died in 2010 from overdosing on painkillers like OxyContin and Opana.

That’s why the FDA is considering a proposal to restrict access to the drugs making it harder to get a prescription.

But that’s just part of the plan to tackle the problem. The agency is playing a bigger role in the $8.5 billion dollar painkiller market, challenging the drug industry to build a painkiller that’s harder to abuse.

“The federal government is going to be a player as never before in this market,” says Dan Carpenter, professor at Harvard University and author of the book “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA.”

Historically, Carpenter says that once the agency approved drugs, it didn’t mettle after with them again. But, it’s different with painkillers.   

“The federal government is actively shaping the way in which the drug is consumed.”

The FDA wants new drug formulations that make it very hard to get high, like pain pills you can’t crush into a powder to shoot or snort, as well as more rigorous, independent testing.   

The FDA is wading into the marketplace because addiction to painkillers, both prescribed and taken illegally, is soaring.  

IHS analyst Gustav Ando says the FDA is dangling a sweet carrot. “The rewards here are pretty big,” says Ando

If a drug maker comes up with a tamper-proof drug, the FDA will label it “proven to reduce abuse,” which could lead to more prescriptions — or as Ando says, gold.

“Pharmaceutical companies really go where the money is,” he explains. “Providing the next generation painkiller — you can’t ask for much more than that.”

Right now, the painkiller market is dominated by generics. A new safer pill would let Big Pharma grab a chunk of that back.

“This is one of these ironic circumstances, in which…the big line companies will actually do better, even though they are being heavily regulated,” says Harvard’s Dan Carpenter.

Philadelphia doctor Aviva Fohrer treats opioid addicts. She likes the idea of a safer painkiller, but there are tradeoffs.

“They’ll get a cheaper, easier drug, which is generally heroin. And the ramifications of that are it’s not produced by a pharmaceutical company. You don’t know what the doses are, you don’t know what’s in it,” Fohrer says.

Fohrer points out the new generation of pills — if developed — are still dangerously addictive. That’s why the doctor says the solution has to be more than yet another pill, albeit one that’s harder to abuse.

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