Reckitt Benckiser's expert questions moves to withdraw suboxone tablets
|
Version 0 of 1. Plans by Reckitt Benckiser to bounce US doctors and drug regulators into migrating addicts on to its patent-protected heroin substitute drug have been called into question after comments from one of the company's independent experts. Reckitt, which is better known for making household goods such as Vanish, Finish, Dettol and Cillit Bang, still generates more than 20% of its operating profit from a legacy pharmaceuticals division which sells opioid dependency treatments – substantially to Medicaid-funded programmes in America. After 10 years marketing its suboxone pills in the US, the company said last week it had voluntarily decided to withdraw the tablets from the market. Reckitt told investors it had "received an analysis of data" indicating the pills were more likely to be accidentally taken by young children than an alternative version of the product – an under-the-tongue strip – also owned by Reckitt. Strip suboxone is protected from competitor products by patent, but the tablet version lost its exclusive marketing rights in the US two years ago. Before the move last week, Reckitt had repeatedly warned investors to expect a fall of up to 80% in sales and profits from the tablets when a generic copycat pill reached the market. Hours after announcing it was to withdraw the tablets, Reckitt revealed it had simultaneously submitted a so-called "citizen petition" to the Food and Drug Administration, urging the US regulator to ban any future competitor pills to its suboxone tablets that were insufficiently "child resistent". A company spokesman has insisted commercial motives played no part in Reckitt's decision to withdraw suboxone tablets from the market. However, Martin Deboo, an analyst at Investec Securites said: "We view these moves as consistent with Reckitt's strategy of protecting the suboxone franchise by hastening migration to [strip] and raising barriers to entry to generics." The FDA has so far chosen not to ban the pills. "We can't comment on this issue as the agency has not yet reviewed the data leading to the sponsor's [Reckitt's] decision," a spokeswoman said. Reckitt told the Guardian it had previously urged the FDA to impose such a ban but had been frustrated. "They were not prepared to accept our assertion that we thought that there was a paediatric exposure benefit of the [strip] without us providing scientific data to prove it." Under US law, the regulator is however obliged to review a citizen petition – though one US healthcare expert said the process often takes years and few such actions started by drug companies have been successful. The Guardian has learned that the data analysis cited last week by Reckitt as the reason for withdrawing the tablets was commissioned by the company itself – a fact omitted from its statement. Dr Rick Dart, executive director of Denver-based drug addiction monitoring group Radars, recruited by Reckitt to carry out the study, confirmed that the statement had accurately highlighted a significantly higher incidence of young children accidently exposed to suboxone pills when compared with child exposure rates linked to suboxone strips. He said this appeared to be because each strip dose was packaged individually in a wrapper that was difficult for a child to open, while the pills came loose, in a bottle of 30. Asked if Reckitt might have considered other alternatives than discontinuing the pills, Dart said: "There are other things they could do, certainly … They could put it [suboxone] in a blister pack. Every study shows that decreases exposure to small children". A spokeswoman for Reckitt said: "We did look at the US suboxone tablets going into the new child-resistent blister packaging technology, but with the formulation of suboxone in the US we have not been able to develop a robust enough solution on which to submit a change. Even if we resolved these technical issues today, we would still have to go through the validation and regulatory registration change approvals process, which could take a minimum of another 9-12 months. "We were not prepared to wait on something yet unproven to implement the needed safety initiative." The group pointed out there had been four child deaths in five years because infants had accidentally managed to get hold of its pills. "This is not a theoretical risk. It is real." The latest official figures show about 2m Americans abused or were dependent on prescription opioid painkillers in 2010, with a further 400,000 people using heroin. Last year, in a saga unrelated to suboxone, Reckitt was fined £10.2m by the Office of Fair Trading in the UK after it was found to have engaged in anti-competitive behaviour following the expiry of a patent on its Gaviscon heartburn treatment. The penalty followed whistleblower revelations which helped prove Reckitt had hoped to prosper by removing Gaviscon Original Liquid from a list of prescription drugs available to NHS patients shortly after the expiry of a patent. This delisting, the OFT concluded, was designed to make it harder for chemists to identify cheaper generic alternatives and to boost sales of Reckitt's new variant Gaviscon Advance Liquid. The Advance Liquid product was in patent and therefore not subject to generic competition. After initial denials, Reckitt did admit abusing its dominant position in the market for heartburn medicines. However it has not settled a parallel £90m civil claim brought by the Department of Health and filed more than 18 months ago. There is no suggestion that moves to withdraw suboxone tablets from the US market risks breaching competition law, in America or elsewhere. "The RB Gaviscon case is in no way similar to that of suboxone and is irrelevant in this context," the company said. "This [suboxone] issue involves serious child safety risk." |