P&G, which along with Sanofi-Aventis markets rival osteoporosis drug Actonel, sued Boniva marketers Hoffman-La Roche and GlaxoSmithKline in January, claiming that ads, sales materials and sales raps falsely said or implied that Boniva, which need be taken only once monthly, was as effective as Actonel, which must be taken weekly, at preventing bone fractures beyond the spine.
The Food and Drug Administration has approved Actonel for prevention of spinal and some non-spinal fractures, but it did not specify treatment of non-spinal fractures for Boniva. P&G contended its surveys showed Boniva ads from Publicis Groupe's Saatchi & Saatchi, New York, led consumers to believe the two drugs work the same, and that Roche sales materials and pitches led doctors to believe likewise.
The court ruled P&G's surveys inadmissible, noting a sample size of only 63 doctors for the professional survey and several flaws in the consumer research, including potentially leading questions and the fact that some interviewers were teenagers. But it also questioned whether the drugs have significant differences beyond their dosing.
U.S. District Court Judge Paul A Crotty took P&G to task for not revealing until midway through hearings on the injunction, after a break for Memorial Day weekend, that the FDA on May 4 had rejected as misleading P&G's own proposed ad suggesting Actonel works better than Boniva on bones beyond the spine.
Actonel's own ad problems
"The proposed TV ad misleadingly suggests that Actonel is superior to Boniva, when such has not been demonstrated by substantial evidence," according to the FDA letter cited by the court. "Actonel failed to reduce fractures better than placebo at leg and hip and in fact was worse than placebo at collarbone," the letter continued.
"The document was withheld from two key witnesses for P&G," the court said in its ruling, "allowing them to testify without knowledge that the FDA had questioned, in effect, the entire basic premise of P&G's argument to the court." The FDA letter figured heavily in the court's rejection of P&G's arguments.
While early Boniva sales efforts aimed to persuade doctors that all the bisphosphonates -- such as Actonel and category leader Fosamax from Merck & Co. -- had similar effects, Roche had dropped such wording from sales materials 10 months ago, the court said. The ruling appears to open the door for Roche to make that argument again, noting that the FDA letter would make it difficult to find such a claim false or misleading.
"P&G's primary concern is not the public health and safety, but its market share," the ruling said, noting that Actonel's share appears to have declined in the $3 billion osteoporosis drug market as Boniva achieved a 5% to 8% share since its launch last year. But the court said it wasn't clear P&G was financially harmed, because the market may have grown sufficiently to make up for the loss of share.
The ruling also noted that P&G had tried and failed three times to get the FDA to halt Boniva ads and portrayed the lawsuit as part of an effort, citing a P&G document, to stop Boniva "in the starting blocks."
"Our intent is to ensure patients and their physicians are aware of both the importance of non-vertebral fracture protection and the evidence supporting this benefit for the medications they are taking," P&G said in a statement. "We are disappointed the court declined to intervene in this case."
"We believe this preliminary ruling confirms what we've always known -- our advertising is truthful and appropriately reflects the available information about Boniva," Richard Hinson, VP-commercial operations at Roche, said in a statement.