GENERIC DRUGS: Industry Sues U.S. Over Pediatric Policy
Two trade groups representing the generic drug industry have filed suit against the federal government, alleging that new FDA regulations on pediatric testing of drugs allow large pharmaceutical firms to unfairly extend patent and exclusivity rights. As part of the FDA Modernization Act of 1997, the government agreed to give "companies that study a drug's effect in children the right to keep generic versions of their product off the market for an extra six months." The move was an effort to bolster knowledge of the effects of drugs on children, which many warned had been lacking. However, generic drugmakers argue that the FDA is allowing companies to "extend their marketing exclusivity on entire lines of products rather than on just the one drug studied for pediatric use." For example, Glaxo Wellcome is researching the effects of an injectable form of Zantac for infants. However, the FDA has extended its patent for all forms of Zantac, including its popular over-the-counter product. G. Thomas Long, legislative counsel to the National Pharmaceutical Alliance, one of the groups bringing the suit, said, "This raises the question of what the incentives really are."
The Wall Street Journal reports that the average drug company spends between $250,000 to $1 million to research a drug's effects on children. An extra six months of patent protection, however, could mean a windfall of about $50 million. Timothy Westmoreland of the Elizabeth Glaser Pediatric AIDS Foundation sees no problem with such an arrangement. He said, "We went in knowing we were rewarding the drug companies too richly. But our past history shows that was the only way of motivating them." Thus far, the agency has granted permission to conduct studies on 39 drugs and issued exclusivity extensions for five of them -- Zantac, Motrin, Advil, Versed and Ziagen (Sharpe, 2/23).