Drug development is risky and expensive, thanks to the long testing and approval process. That’s why in 1984, the U.S. Congress struck a bargain with pharmaceutical companies. If they brought a new therapy to market, they won exclusive rights to sell that product in the U.S. for a limited amount of time. After that, generic drugs could be made by competitors — at competitive prices. But increasingly, makers of branded drugs are using a variety of tactics to extend their exclusive rights. They’re using “pay-for-delay” agreements, citizen petitions, restricted distribution schemes, and legal challenges to delay the introduction of cheaper generic drugs. (Generic drug makers aren’t helping themselves by having issues with manufacturing quality.) These delay tactics are costing consumers billions of dollars a year. The federal government should clamp down on these loopholes.
