Orrin Hatch: “I rise to commend our colleagues, Senators Gregg, Burr, and Coburn, for their introduction today of the Affordable…”

“I rise to commend our colleagues, Senators Gregg, Burr, and Coburn, for their introduction today of the Affordable Biologics for Consumers Act, S. 1505. As my colleagues are aware, I am the original author with Representative Henry Waxman of the Drug Price Competition and Patent Term Restoration Act, a law which gave rise to today's generic drug industry. And so, I have a long-standing interest in making certain that consumers have access to affordable medications and that we provide the appropriate incentives for development of the new products that are eventually to be copied. We must rectify the fact that there is no clear pathway for follow-on copies of biological products, such as human growth hormone or insulin, to take two easy examples. And it must be rectified on a priority basis. That the Hatch-Waxman law did not cover these biologic products was not a simple omission. Indeed, the market for biologicals really did not develop until after enactment of Waxman-Hatch in 1984. For many years, I have worked toward development of a pathway for these 'follow-on' products, but it was not until recently that I believe we have developed a public consensus that there is the scientific and regulatory underpinning necessary to write a good law. Comes now the Gregg-Burr-Coburn bill, which must be seen as an important contribution to the necessary dialog on follow-on biologics.”