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Editorial: Rules for tamper-resistant drugs should be applied to generics, too

Mar. 14, 2013 @ 11:53 PM

Attorneys general from 48 U.S. states and territories made it clear this week that they support the U.S. Food and Drug Administration's efforts to make drug manufacturers more accountable for preventing abuse of powerful opioid drugs.

But the coalition also pointed out a potential gap in the FDA's efforts and asked that the federal agency takes steps to plug it. The FDA should listen.

In its letter, the National Association of Attorneys General praised the FDA's plan to adopt rules encouraging manufacturers to develop opioids that are difficult to crush or dissolve -- two steps often used by abusers of the drugs. Early this year, the FDA released draft guidelines which suggested studies drug companies would have to conduct to show that their opioid products actually deterred abuse.

However, the attorneys general noted, those draft guidelines did not include how the developing standards would apply to generic versions of painkillers. They said they were concerned that if generic painkillers are approved without the same tamper-resistant features, abusers of the drugs will shift to the generic versions so they can more easily be abused.

In announcing his participation in the request to the FDA, West Virginia Attorney General Patrick Morrisey noted the extent of the prescription drug abuse problem in the Mountain State. He cited a study from the Centers for Disease Control that found West Virginia had one of the highest drug overdose death rates in the country. About 25 of every 100,000 people in the state died from an overdose in 2008. Morrisey's counterparts in Ohio and Kentucky also signed the letter.

The fact that so many state representatives joined the request suggests the problem is widespread. About three of every four drug overdoses involve an opioid, according to a CDC study of data from 2010. The number of deaths from opioids has steadily increased over the past 11 years, reaching 16,651 in 2010, the study found.

Both manufacturers of brand-name drugs and makers of the generic formulations have their own perspectives on the issue, and both no doubt will raise questions that could stall implementation of the tamper-resistant rules. For example, last year Purdue Pharma asked the FDA to deny the pending applications by generic drugmakers for their versions of OxyContin unless they met "rigorous" testing for deterring abuse, according to a report by Thomson Reuters. The FDA denied that petition in January. Generic manufacturers say tactics like that are aimed at allowing the brand manufacturer to keep its patent on a drug. Likewise, the generic manufacturers say trying to duplicate recently employed tamper-resistant features could put them afoul of patent law.

Despite the respective issues put forth by the brand-name and generic drug manufacturers, the FDA should move forward with a plan to require both segments to produce abuse-deterrent formulations. It's been a slow process to get the brand-name manufacturers to take greater accountability for the prescription-drug abuse problem. There shouldn't be any backsliding on that progress, and generic manufacturers should be held to the same standards.



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