The rule, which took effect last month, allows opioid treatment programs to dispense the drug without various take-home restrictions. "He is a godsend to them and a huge loss to the federal government, and to anybody who wants to come up with another, cheaper alternative" to Suboxone, Knopf says. "He knows the regulations by heart, for OTPs and for... laws allowing physicians to get waivers to treat opioid addicts with an opioid. He is an encylopedia."
His arrival may not help Reckitt with all of its myriad issues surrounding Suboxone, but the timing is certainly fortuitous. Apart from combating problems with diversion and abuse, the company is working furiously to promote a newer sublingual, or film version, of its drug, while preventing generic drugmakers from selling low-cost versions of its older tablet, which is being withdrawn from the US market.
Toward this end, Reckitt has argued that children could be accidentally harmed by easy access to tablets that are marketed in bottles as a justification for withdrawing its tablet. Reckitt recently cited specially commissioned data showing higher rates of "accidental unsupervised pediatric exposure” with Suboxone tablets than with Suboxone Film, which can only be accessed by tearing open individual blister packaging but was never used for its tablets.
At the same time, Reckitt filed a Citizen’s Petition with the FDA, asking the agency not to approve any generic versions of Suboxone tablets unless manufacturers implement "national public health safeguards" to reduce pediatric risk (back story). The FDA asked Reckitt to work with generic drugmakers to develop a Risk Evaluation & Mitigation Strategy, or REMS, but has been accused of feigning cooperation as a delaying tactic to build Suboxone film sales.
These various moves have, in turn, generated pushback. Generic drugmakers have asked the FDA to deny the Citizen's Petition (read more here). And lawsuits have been filed by Suboxone customers who 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).
Indeed, as Knopf notes, Reckitt still has "major hurdles - transitioning everyone to film, fighting off generics, ... what the FDA is doing with their citizen's petition, huge problems with diversion and abuse, DEA breathing down their necks, getting it paid on formulary - and some serious problems with uninformed politicians who think people should not be on maintenance medications forever."
Nonetheless, Reuter, who also worked as a consumer safety officer in the FDA Office of Health Affairs, can clearly offer some relief. "He's got a wealth of experience working at FDA and SAMHSA," says Mark Parrino, president of the American Association for the Treatment of Opioid Dependence, which works with federal agencies and state substance abuse authorities on opioid treatment policy. "It is a very smart move for Reckitt to have brought someone on with his knowledge of federal regulatory and policy rulemaking."