This week’s issue of Alcohol and Drug Abuse Weekly ran a front page article about the FDA’s recent ruling on Reckitt Benckiser’s requests. Reckitt, the manufacturer of buprenorphine (Suboxone and Subutex), had submitted a Citizen’s Petition to the FDA, asking them to refuse to approve any form of buprenorphine that didn’t have additional child-resistant safety measures.
Last year, Reckitt said they were taking the tablet form off the market because of increased risk for pediatric exposure with tablets as compared to the newer film form of Suboxone. Cynics (like me) said this was an attempt to hide profit motives behind claims of concern for children. The film is still under patent, while the patent for the tablet form had already expired. This Citizen’s Petition was felt by some (like me) to be an additional smokescreen, invented to prevent the release of a generic competitor.
In their ruling at the end of February of this year, the FDA said the scientific and regulatory concerns raised by Reckitt’s petition weren’t valid. They said there was no proof of Reckitt’s claim that the unit-dose packaging of the film reduced pediatric exposures. The FDA noted that the new REMS (Risk Evaluation and Mitigation Strategy), put in place for buprenorphine and other opioids, could have caused the decline in pediatric exposures. The FDA has also made efforts to educate physicians about overdose potential in children. The FDA also pointed out that many drugs dangerous to children are packaged in bottles, rather than unit –dose packaging. Also, the FDA pointed out that Reckitt received the pediatric overdose information two years before they announced they would voluntarily stop making the tablets due to pediatric overdose concern. This delay undermined their claim of making the change for patient safety.
The FDA criticized Reckitt for making these safety claims, yet still selling the tablets. In fact, the FDA has asked the Federal Trade Commission, the FTC, to investigate the United Kingdom-based Reckitt-Benckiser for possible anticompetitive business practices.
I admired Reckitt Benckiser when they first released Suboxone. At last, a drug company was willing to take a chance on manufacturing a medication to treat addiction. Since drug addicts often don’t have insurance or money, this is not usually a lucrative market. They took a financial risk. They funded, or helped to fund, many of the training programs doctors needed to get licensed to prescribe Suboxone. Reckitt provided free treatment for a few indigent patients per doctor with their Here to Help program. They provided telephone support to addicts entering Suboxone treatment, at no cost, though few addicts used this benefit.
But over the last few years, Reckitt Benckiser has lost credibility with me. I feel they’ve become heavy-handed, and have pressured doctors to prescribe only the films, saying it’s less likely to be sold on the black market and less likely to be misused than the tablets. That may be true, but some patients don’t like the film, and would leave treatment if it’s the only available medication. And many addicts have written in to this blog, claiming to be able to dilute and inject the films more easily than the tablets. At the same time, the prices of the Suboxone tablets skyrocketed, in an attempt to force patients to switch to films. Reckitt of course also discouraged doctors from prescribing the less expensive generic monoproduct buprenorphine, which costs less than half of the name brand manufactured by Reckitt.
Then there was that whole pediatric overdose issue. After that, my opinion of Reckitt fell. They lost credibility with me.
The two drug companies that make the generic form of Suboxone say their tablets should be available in pharmacies within a month. Actavis, based in New Jersey, is the third largest manufacturer of generic medications. The other manufacturer, Amnel Pharmaceutical, is also based in New Jersey and is the 7th largest generic manufacturer. Amnel’s press release describes their tablet as being cheaper than Suboxone, with a “pleasant orange flavor.”
I can’t wait to see how much these generics will cost. I’d expect them to be a little more expensive than the generic monoproduct buprenorphine. In my area, that generic sells for around three to four dollars per pill, less than half what the name brand Suboxone costs now.
The release of these two generics will likely mean more patients will be able to afford addiction treatment. The more affordable treatment becomes, the more patients will take advantage of help for their addiction.
Huzzah for the FDA! This was a good decision.