This article originally appeared in STAT on 28th September 2016.
Banning “pay-for-delay” deals that postpone the production of less-expensive generic drugs is a key action point in Hillary Clinton’s comprehensive plan to lower prescription drug costs. Eliminating these deals, she says, could save Americans billions of dollars on medications. But an even more productive strategy would be to stop drug makers from producing so-called authorized generics. (I tried to examine Donald Trump’s thoughts on this issue. While his website says he will remove “barriers to entry into free markets for drug providers,” no details are provided and no mention is made of pay-for-delay deals.)
A patent on a new therapeutic molecule is granted for 20 years, though its validity can be challenged at any time. Much of that 20-year window is often spent formulating the drug and testing it in animal studies and clinical trials. Acknowledging this delay, the Hatch-Waxman Act provides an incentive for drug development by granting the patent holder five years of market exclusivity during which no competitor can file to produce a generic variant. Not surprisingly, the price of the drug is high during this period.