The AP reports that for the first time the biotechnology drug industry via its trade association, the Biotech Industry Association, signalled its willingess to accept a law that creates a pathway for generic versions of biological drugs. The AP article suggests however that it is unlikely that such a law will be enacted this year. The generic drug trade association, the Generic Pharmaceutical Association, is not rushing for a deal this year because it expects a more favorably disposed Congress next year.
On February 15, the Food and Drug Administration published a proposed rule providing prescription drug manufacturers with guidance on “Good Reprint Practices” which explain the difference between appropriate distribution of scholarly articles on off-label uses of prescription drugs and illegal marketing of off-label uses. An AP report explains that “Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.” The proposed rule will fill a gap in the law created when a law governing the practice expired in 2006. Rep. Henry Waxman (D Calif) plans to examine the proposed rule.