CLARITIN: GAO Report Helps Patent Extension Effort
Fueling the epic battle on Capitol hill over whether blockbuster drug Claritin deserves a patent extension, a recently released General Accounting Office report claims that the FDA "took longer than usual" to approve Schering-Plough's antihistamine drug, the Wall Street Journal reports. The report states that Claritin's application was submitted in October 1986 and approved 77 months later, "almost three years longer than the average 42.5 months for similarly classified" medications. According to the report, the FDA said the delay was a result of concerns surrounding the drug's safety and insufficient materials submitted by Schering-Plough. The patent, which prevents low-cost generic versions of Claritin from entering the market, expires in 2002, but could potentially be extended by bills currently under debate in Congress. The pending legislation would give drugmakers the opportunity to petition the U.S. Court of Claims for patent extensions. Schering-Plough spokesperson Denise Foy said of the GAO report, "It's not the company's intent to criticize the FDA or suggest it should not be cautious, but when a company is diligent and a review is unusually long, the company should not be penalized by the loss of effective patent life." A patent extension would give Schering-Plough a huge financial boost in the coming years, as Claritin's sales totaled $2.3 billion during 1999. Schering said that during the drug's six-year long FDA approval process, the agency "needlessly delayed" the approval by "rehashing debates that ... had been settled." Schering also argued that an FDA reorganization "resulted in inefficiencies and delay when new reviewers reexamined data that had been accepted by the first reviewers." Schering-Plough claims that the FDA's reevaluation of data that indicated the drug might cause cancer in laboratory animals resulted in the loss of "about four years of effective patent protection." The FDA countered that it was "uncertain that Claritin met the safety requirements ... and investigated the drug until they were convinced" (Adams, 8/14).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.