On April 16, in a win for Purdue Pharma, the maker of OxyContin, the FDA issued a decision approving updated labeling for Purdue’s reformulated, abuse-resistant OxyContin tablets. The decision places drug makers on notice that the FDA will not accept or approve any abbreviated new drug applications (generics) that rely upon the agency’s December 1995 approval of Purdue’s original OxyContin formulation.
The FDA’s decision was issued just as Purdue was set to lose its patent on the original formulation of OxyContin. Loss of this patent would have opened the opioid-painkiller market to competition from generic drug makers. But now, going forward, new applications for generic “copycat” forms of the drug must meet Purdue’s approved, abuse-resistant standard, without infringing upon Purdue’s patent for reformulated OxyContin, which lasts until 2025.
Concern over abuse of the well-known painkiller was central to the FDA’s decision. The agency explained, in a press release accompanying its decision: Purdue’s “labeling indicates that the [reformulated] product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).” The press release further stated that: The original formulation of OxyContin “was abused, often following manipulation intended to defeat its extended-release properties. Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death.”
According to the New York Times, the FDA’s decision was pushed by some state attorneys general, as well as pain treatment experts, who argued that the release of generic versions of OxyContin would feed street demand for the narcotic. Critics, however, have argued that the decision will result in higher prices for OxyContin, as the reformulated drug will not face generic competition.
An FDA official acknowledged to the New York Times that the agency is “looking at new territory” with respect to the standards under which it will allow claims for abuse-resistant narcotics.
The FDA’s decision raises questions regarding the extent to which drug makers can, in the future, protect their patents via claims regarding abuse-resistance. In comments made to the FDA, the Generic Pharmaceutical Association contended that if the FDA blocked generics relying on the original formulation of OxyContin, the agency would create a “clear path” for other companies to develop abuse-resistant drugs in order to stifle competition. However, according to Katie Reilly, a Husch Blackwell attorney and antitrust law expert, the FDA’s decision is unlikely to limit competition.
OxyContin and similar opioid painkillers are unique given their rampant abuse. I do not believe generic manufacturers should be concerned because the FDA’s decision is unlikely to be expanded outside of this narrow market,” said Reilly.
Further developments within this new regulatory territory will clarify this debate, particularly as makers of generic opioid painkillers recalibrate their efforts to win FDA approval for OxyContin alternatives.