Points offers a post summarizing the history of Suboxone up to the present.
Including the role of NIDA in helping Reckitt:
Reckitt brought Subutex and Suboxone to market with part of the costs of development absorbed by NIDA “to ease the burden to Reckitts” (Campbell and Lovell 2012: 135). They note that Reckitt had also obtained “orphan drug status” using the Cost Recovery principle “that the company risked not recuperating what it invested” given relatively high manufacturing costs, even though the size of the target market was greater than the 200,000 potential patients for so-called “orphan” drugs. This status resulted in seven years of patent exclusivity.
Their maneuvers to maintain control of the drug:
Ed Silverman, in an article at Forbes.com, noted that Reckitt was manipulating the cost of the tablet to encourage insurers to switch patients over to the film. According to his data, Reckitt raised the price of the bottle of 30 tablets from $140 to $1
61.70 for the 2 mg dose and from $252 to $289.80 for the 8 mg dose, while the film version cost $117.85 for 30 2 mg films and $211.15 for the 8 mg version. They also offered a $45 monthly subsidy (Bloomberg reported it as a “Coke-style coupon”) for a patient’s typical $50 co-pay for the film. Within six months of the introduction of the film, 40% of patients had been switched over to this new formulation, and by the end of 2012, it was 64%.
Hours after announcing their plan to take the tablets off the market, Reckitt announced in a press release that they had filed a “citizen’s petition” urging the FDA to “require all manufacturers of buprenorphine-containing products for the treatment of opioid dependence to implement national public health safeguards involving pediatric exposure educational campaigns and child resistant, unit-dosed packaging to reduce the risk of pediatric exposure.” They asked the FDA to reject any new drug applications for generic suboxone tablets.
And their future plans:
Reckitt continues to look for greener pastures, including trying to develop an injectable, long-acting depot version of buprenorphine (they also just hired a veteran of SAMSHA to help them navigate the federal regulations). Their story is testament to the new pharmaceutical economies built up around managing the poor and the sick. It also speaks to the booming business of addiction treatment and the increasingly larger part that Big Pharma wants to play in shaping and legislating notions of risk, safety, and public health. Would this situation have been possible if Reckitt had not been able to play on the unique cultural and moral attitudes that our country has towards drug addiction, such as the fear of children overdosing on drugs meant for drug addicts?
- Reckitt loses bid to change US drug packaging rules (telegraph.co.uk)
- Generic drug makers get green light to make Reckitt’s heroin substitute (guardian.co.uk)
- Reckitt hurt as rivals steal heroin march (independent.co.uk)
- Reckitt Benckiser faces inquiry over move to block heroin substitutes (guardian.co.uk)