Less than a month after the White House warned of a potential influx of painkillers from Canada that government officials say are easier for addicts to abuse, the U.S. Food and Drug Administration has approved a similar pill for distribution nationwide.
Amid growing concerns of abuse of their products, Purdue Pharma and Endo Pharmaceuticals reformulated OxyContin and OPANA so that the pills were more difficult to abuse by prescription painkiller addicts. Abusers typically crushed those generally time-released pills into a powder and injected them, allowing their bodies to get the full dosage at one time.
Developed in 2010, the new, tamper-resistant pills are designed to break into non-injectable chunks or gels, making them harder to abuse.
But late last year, Canada approved generic forms of OxyContin that uses its earlier formula, prompting the Obama administration to alert law-enforcement agencies to be on the lookout for illegal trafficking of the drugs.
"The potential exists for diversion into the United States because the old formulations, which are easier to abuse, are unavailable in the United States," the alert, issued in December, said.
But in a seeming reversal, the FDA approved a generic form of OPANA early this year that critics, such as Rep. Bill Keating (D-Mass.), say represents a "complete contradiction" from the Obama administration. In April, a generic form of OxyContin will become available unless the FDA decides to step in.
Keating is the sponsor of the Stop Tampering of Prescription Pills Act, a 2012 bill that would require generic drug manufacturers to meet the same safety requirements that brand-name manufacturers have. He says he plans to reintroduce the legislation during this legislative session.
"To not be doing something about this is an outrage," he says.
The Centers for Disease Control says that 15,000 people die annually from prescription drug overdoses. Impax Laboratories, who makes the generic OPANA, announced Jan. 4 that it had begun shipping its pills.
Michael Barnes, a spokesperson for the Center for Lawful Access and Abuse Deterrence, a nonprofit group that works to stop prescription drug abuse, says the move is a step backward.
"The FDA's actions have proved they're not really committed to fostering a transition to tamper-resistant drugs," he says. "The FDA has allowed generic manufacturers to bring the old, abusable formula back."
Libby Holman, a spokesperson for Purdue Pharma, says that early studies on the new pills suggest that they are abused less frequently and that the company "reformulated OxyContin in hopes that it would be harder to abuse."
"We started working on reformulation with hopes of it being harder to abuse a decade ago," she says. "We think it's important for public health and safety."
Law enforcement officials say that the new formulas have had an impact on the street. In Florida, which has one of the country's worst prescription-pill addiction problems, there has been a premium placed on black-market pills that utilize the old, crushable formula. David Gross, a special agent supervisor with the Florida Department of Law Enforcement, says the old formula is "much easier to manipulate and abuse."
"The street price for the crushable version of [the drug] is much higher, it's more desired because it has the ability to be misused," he says. "The tamper-resistant versions are more of a last resort. The supply of the crushables are down, but the demand is still unfortunately there."
Gross says that new generics from Canada "haven't filtered down" to Florida yet, but that his team has begun looking for them, and that the new FDA approval of generic OPANA could bring a new supply of cheap pills from within the United States.
The FDA says it has received a number of "Citizens Petitions" to reverse its decision on generic OPANA and that it could not comment on the "substance, details or timing of our deliberations on these petitions," but that it is "actively reviewing" them. Requests for comment from the White House were not returned.