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Drug Companies Want Ban on Generic Painkillers, Arguing Safety is at Stake

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Drug companies that manufacture the painkillers OxyContin and Opana are trying to block generic drug makers’ efforts to produce cheaper versions of the drugs. They argue these newer drugs will not have the tamper-resistant designs used in making the brand-name pills, according to The New York Times.

Generic versions of the two painkillers are expected to be significantly less expensive than the brand-name drugs.

Purdue Pharma, which makes OxyContin, and Endo Pharmaceuticals, which manufactures Opana, produce versions of the drugs that are more resistant to melting or crushing, which makes them more difficult to abuse. The companies say generic versions of the drugs without these safety features will increase demand for the drugs and lead to a rise in painkiller abuse.

Both companies support state and federal legislation that would require many opioids to be tamper-resistant, the article notes. The manufacturers are also asking the Food and Drug Administration (FDA) to differentiate between drugs with tamper-resistant features and those without such qualities.

A bill introduced in the U.S. House this summer would require most painkillers to have safeguards to prevent abuse. Under the provisions of the bill, most prescription painkillers would have some form of abuse deterrence, such as being more difficult to crush or inject. If pain medications did not adopt the safety features outlined in the bill, they would be removed from the FDA’s approved list of generic drugs.

In December, a federal judge threw out a lawsuit by Endo that aimed to block the FDA from allowing generic versions of Opana. The newspaper quotes court papers filed in response to Endo’s lawsuit, in which the FDA called the company’s action a “thinly veiled attempt to maintain its market share and block generic competition.”

1 Response to this article

  1. Norma Norris / January 3, 2013 at 4:30 pm

    The drug manufacturer has a point, but it is not out of any safety concerns. This just may be the ticket to cover what they will lose when the patent expires this year. Afterall, their pediatric trials for OxyContin only gave them a 6 month patent extension. I wonder if a report on the number of kids addicted to OxyContin after these trials will be released?

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