Generic Drug Makers Await FDA Decision on OxyContin

Generic drug makers are waiting for the Food and Drug Administration (FDA) to decide whether they must make tamper-resistant forms of OxyContin, or if they can produce the original version, The Wall Street Journal reports. OxyContin’s first patent expires Tuesday.

In making its decision, the FDA must weigh the significant problem of prescription drug abuse against the need for generic painkillers that are effective and inexpensive. The FDA’s decision could influence proposed federal legislation that would require most prescription painkillers to have tamper-resistant formulas.

Annual sales of OxyContin, at $2.8 billion, represented about 30 percent of the painkiller market last year, according to the newspaper.

The original version of OxyContin was easy to heat or crush, allowing users to inject, snort or smoke the drug. In 2010, the drug’s manufacturer, Purdue Pharma, introduced a tamper-resistant formula that made the pill harder to crush.

The FDA could allow generic drug makers to produce the original version, which would be inexpensive to make. The agency might decide generic companies could only make versions that use Purdue’s abuse-deterrent formula, which does not come off patent until 2025. Or it could allow generic drug makers to make their own versions of abuse deterrents.

Last month, the group representing the nation’s attorneys general called on the FDA to require manufacturers and marketers of generic prescription pain drugs to develop versions of their products that are resistant to tampering and abuse.

In a letter, the National Association of Attorneys General told the FDA, “In our states, nonmedical users are shifting away from the new tamper-resistant formulations to non-tamper-resistant formulations of other opioids as well as to illegal drugs. There is great concern in our law enforcement community that many non-tamper-resistant products are available for abuse when only a few products have been formulated with tamper-resistant features.”