BIO Supports 14-Years of Exclusivity that Runs Concurrent with Patent Term; Repeats Call For Timely Action on FOB’s Bill WASHINGTON, D.C. (Tuesday, April 01, 2008) - In light of recent news reports in which the generic drug industry’s lobby group has mischaracterized the Biotechnology Industry Organization’s (BIO) position on follow-on biologics, BIO issued the following statement today:
“The generic drug industry’s lobby continues to grossly mischaracterize BIO’s position on follow-on biologics. Regrettably, rather than engaging in a debate based on facts and credible data, the generic drug industry’s lobby keeps pushing misinformation to the news media, policymakers, and others that is flat out wrong. We are taking this opportunity to set the record straight.
“The generic industry drug lobby has tried to muddy the conversation by erroneously claiming we are seeking 14 years of market exclusivity beyond the patent term. Our position has long been consistent and clear: any legislation to create a regulatory pathway for follow-on biologics should provide 14 years of data exclusivity for the pioneering product, a period that runs concurrent with a drug’s patent term. Data exclusivity is the time period after approval of the innovator’s product during which the Food and Drug Administration may not approve a follow-on biologic (FOB) product relying to any degree on the safety and efficacy of the innovator product.
“Some in the generic drug industry lobby seek to delay follow-on biologics legislation until the next Administration in the hopes of securing a better deal. A generics industry lobbyist was recently quoted as saying, ‘Now, if you ask [generics] if they'll cut the same deal [as 2007], the answer is, ‘Hell, no.’ They’ll say, ‘Let’s wait a year and screw Big PhRMA [and BIO] really hard.’*
“BIO strongly supports bipartisan efforts to pass legislation to create a pathway for approval of follow-on biologics this year. This issue is too important to subject to special-interest politics and misinformation campaigns. Patients, employers, and public programs such as Medicare have waited long enough. The time for responsible follow-on biologics legislation is now.”
*Politico, January 16, 2008