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Schumer Says FDA Should Require Generic Versions Of Addictive Pain Killers To Have Same Protections As Branded Versions

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Location: New York, NY

U.S. Senator Charles E. Schumer today announced that he is urging the Food and Drug Administration (FDA) to take steps to prevent a potentially significant increase in violent prescription drug thefts and addiction that could be caused by the release of a generic version of Oxycodone next month. A generic version of the highly addictive painkiller loses patent protection in April. There is currently no requirement that generic versions have the "anti-abuse" features currently used in the branded version. The branded versions of the pills turn to gels or chunks when broken, making it impossible to inject or snort the contents. Currently the FDA doesn't require the generic version to have such features, making them vastly more appealing to drug addicts. According to law enforcement, anti-abuse features make the pills far less valuable, and thus less likely to be the target of deadly pharmacy robberies.

Schumer today urged the FDA to require the same security features on generic versions of highly addictive painkillers as they do on the branded versions. He said that New York and the United States are going through a significant prescription drug abuse epidemic and allowing the market to be flooded with easily abused pain pills would be a huge step backwards. Schumer stood at a pharmacy that was the target of a violent pharmacy robbery last year.

"We are in the midst of a prescription drug abuse epidemic and allowing these pills on the street with no anti-abuse mechanisms would open the floodgates even further," said Schumer. "Pills that are easily crushed or altered are far more valuable than the versions that can't be tampered with, making pharmacies and people that carry them a target for violent thieves. The FDA should ensure that these generic pills have equivalent protections as their branded counterparts, for everyone's safety."

Oxycodone is a highly addictive prescription painkiller and dominates, along with hydrocodone, the targeted pills sought in prescription drug robberies. According to the federal Centers for Disease Control and Prevention (CDC), since 2003, there have been more overdose deaths involving opioids than those involving heroin and cocaine combined. Prescription drug overdoses killed 20,444 Americans in 2008; of these, 74 percent involved opioid pain relievers.

Two months ago, the FDA issued a draft guidance to assist prescription drug manufacturers developing technology to thwart prescription drug abuse. However, the FDA is not requiring drug makers to develop and use abuse-deterrent painkillers, which are designed to prevent people from crushing and then snorting. This month, 48 Attorney Generals from around the country, including New York, sent a letter to the FDA urging the FDA to assure that generic versions of opioids have abuse-deterrent features.

In 2010, OxyContin released a new and "anti-abuse" version of the drug which turns into a gummy gel when you attempt to crush it, making it much more difficult or nearly impossible to snort. Prior to the existing version, the pill turned into a fine powder and has since been discontinued and no longer available in the United States. According to law enforcement, the street price for the crushable version is much higher than the "anti-abuse" version, since it can provide a better high to addicts.

The FDA recently approved a generic form of one of the most widely abused opioid painkillers, Opana ER, made by Endo Health Solutions. The highly addictive pain medication Oxycontin loses patent protection this coming April and FDA will soon have to make a determination on how to approach generic versions of this drug. Schumer said that the first step in balancing generic access to this important medication while preventing drug abuse is for the right abuse deterrent technology to be established.

Schumer today urged the FDA to require that the generic version of Oxycontin have similar and effective "anti-abuse" technology that will make the drug much more difficult for addicts to snort or inject, thereby making it less of a target for violent thieves. Schumer plans to introduce legislation that will address the use of abuse deterrent technology and will encourage the FDA to be responsible in balancing generic access to necessary medications while combating prescription drug abuse.

Schumer explained that the FDA must be specific about which abuse deterrent technology is effective and establish a standard for all pharmaceutical companies. Schumer made the case that a generic version, without "anti-abuse" technology could make the painkillers more valuable to thieves and addicts, leading to more violent pharmacy robberies.


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