Wouldn a short period of data exclusivity for biologic drugs inhibit innovation?
No. A shorter period of exclusivity would actually lead to more innovation in the biologics industry. Since the birth of generic competition with the enactment of Hatch-Waxman in 1984, there has been unprecedented savings for consumers and investment in new drug research and development, which in turn has led to a period of unparalleled pharmaceutical innovation. It’s important to note that Hatch-Waxman provides five years of data exclusivity for innovators – well under the 12 years being considered now for biologics. Innovator companies argue for long exclusivity periods for their products, saying that the cost of developing biologics is so expensive that they need more time without competition to gain back their expenses and save jobs for their workers. But a recent study by AARP’s Public Policy Institute reveals that manufacturers of many top-selling biologic drugs have recouped average research and development costs several times over in the past six years, often within a single ye