One of the hottest topics in the pharmaceutical industry today is the so-called "pay-to-delay" ban that is working its way through Congress. Basically, the bill would prevent drug companies from paying generic drug makers to delay the introduction of generic drugs that would compete with name-brand drugs that have expiring patents. The Federal Trade Commission (FTC), chaired by Jon Leibowitz, is pushing for this ban as a means of lowering drug costs to consumers. So far, the record is mixed and passage of the bill is by no means certain. Big Pharma, of course, is lobbying hard to scuttle the bill entirely or at least water it down.
Big Pharma is increasingly embracing settlement deals in which generic makers receive compensation for delaying competition. The FTC has found that, typically, these deals keep generics off the market for 17 months longer than deals without payments. However, recent court decisions have not ruled these deals illegal, although results are mixed. The US Second Circuit Court of Appeals recently upheld the legality of pay-for-delay deals, but also invited drug purchasers to seek review by the full circuit court, due to the affect a contrary decision would have on antitrust regulations. A federal district court judge in Philadelphia is allowing an FTC suit to go forward against Cephalon over pay-to-delay. Also, the FTC recently lost a case against Solvay Pharmaceuticals for delaying competition of its testosterone-replacement medication.
Even as the trial record is mixed, the Senate appears to be backing away from the ban approved by the House. So the future of this practice is still an open question.
How does this controversy affect the average drug consumer? For example, let's take the case of John Q., a New Yorker and chronic sufferer of repeating lower back pains. After unsuccessfully trying a range of over-the-counter analgesics, he decided to visit a pain clinic to gain a respite from the endless discomfort. He chose Pain Clinic Atlanta due to its excellent reputation, and is looking forward to his first visit. But he is concerned; if he will need to take pain medications, will there be generic versions available so that he can more easily afford them? And is there a potential generic medication that would be especially appropriate to his ailment but is being suppressed by a pay-to-delay deal? These are the questions on his mind as he prepares for his first visit. The pharmaceutical industry is currently wrestling with the same questions.