The decision, which was accompanied by FDA approval of two generic versions, caps a long-running controversy over the Reckitt strategy to maintain its Suboxone franchise. The drugmaker, which is based in the UK and best known for household cleaning products, has used various tactics to convince the FDA that lower-cost generic versions could raise safety issues for children, while bolstering sales of a newer product with a longer patent life.
Since 2010, Reckitt has aggressively promoted its new sublingual Suboxone Film, a newer version of its drug that dissolves under the tongue and can only be accessed by tearing open individual blister packaging. The patent on Suboxone tablets expired three years ago, while the patent on Suboxone Film expires in 2022. And Reckitt has gradually raised the price of Suboxone Tablets in order to switch patients to the newer version (back story).
Meanwhile, Reckitt asked the FDA not to approve generics unless the risk of accidental pediatric exposure was addressed and child-resistant, unit-dose packaging was used, and not until establishing Reckitt was withdrawing Suboxone tablets due to safety issues. Toward that end, Reckitt provided specially commissioned data showing rates of accidental unsupervised pediatric exposure was eight times greater than with its newer Suboxone Film.
In rejecting the citizen's petition, however, the FDA maintains that Reckitt failed to provide sufficient evidence that specific educational measures and unit-dose packaging caused a verifiable decline in accidental pediatric exposures. As a result, the agency determined there is insufficient justification to require such specific steps from generics. Suboxone tablets, by the way, were never sold in unit-dose packaging.
After dispensing with these points, the FDA then laces into Reckitt. For one, the agency notes the drugmaker has not yet withdrawn Suboxone tablets, so that determining whether the tablets are being withdrawn is simply not necessary at this time. And "Reckitt's own actions undermine, to some extent, its claims with respect to the severity of the safety issue," the FDA writes (HERE IS THE LETTER FROM THE FDA TO RECKITT).
Although its own citizen's petition cites data showing an increasing rate of accidental pediatric exposure through early 2010 and the death of a child in June 2010, Reckitt did not seek to halt marketing of multi-dose containers of Suboxone tablets for more than two years. And the FDA then adds that as of last August, Reckitt indicated the Risk Evaluation & Mitigation Strategy, or REMS, had been "successfully implemented" and no changes were planned.
Then, the FDA takes up the anticompetitive complaints from generic drugmakers. "The timing of Reckitt's September 2012 announcement that it would discontinue marketing of the tablet product because of pediatric exposure issues, given its close alignment with the period in which generic competition for thie product was expected to begin, cannot be ignored," write Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research.
There is more to this, however. As we reported previously, generic drugmakers were told by the agency to work with Reckitt on developing a class-wide REMS for their tablets. But the effort stalled, and Reckitt was accused of failing to give any indication that it will cooperate in designing such a REMS and has not shared some of the specifics with the generic drugmakers.
The shared REMS requirement "established a perverse incentive structure and allowed Reckitt to engage in... mishcief," wrote lawyers for Actavis (ACT). "...We are aware of no other context in which a New Drug Application holder has been given direct control over the approvability of Abbreviated New Drug Applications for follow-on generic products" (here is the Actavis letter; read more from the Amneal Pharmaceuticals response here and its latest statement here. The FDA aproved generics from both drugmakers).
The FDA did not actually deny the petition over this issue, but Woodcock did write that the matter is being referred to the FTC, "which has the administrative tools and expertise to investigate and address anticompetitive business practices." And so, instead of getting the FDA to take its side, Reckitt not only lost agency backing, but must now also contend with an FTC probe into its actions.
As we noted the other day, Reckitt already faces lawsuits filed by Suboxone customers, including the Rochester Drug Cooperative, which charge Reckitt acted in an anti-competitive manner by conspiring to suppress generic competition and maintain high prices for its newer Suboxone film (you can read two lawsuits here and here).
"It seems that FDA’s response will dovetail nicely into the private antitrust lawsuits already filed against Reckitt Benckiser for its transparently illegal and monopolistic behavior," says one source familiar with the FDA and its deliberation over citizen's petitions, but who asked not to be named. We asked Reckitt for comment and will update you accordingly.