Although they continue to support bipartisan congressional efforts to enact legislation streamlining FDA approvals of biogenerics, leaders of the generic-drug industry voiced "significant concerns" about the effect of amendments added to the pending Biologics Price Competition and Innovation Act of 2007. Specifically, officials at the Generic Pharmaceutical Association (GPhA) expressed opposition to language that would extend the 12 years of market exclusivity that this legislation grants brand biotechnology companies.
"Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more importantly would unjustifiably delay access to affordable competition and choice for consumers and businesses alike," said GPhA President and Chief Executive Officer Kathleen Jaeger. She also raised objections to "another flawed provision" of the bill that would permit brand companies to make a minor change to their product and receive an additional 12 years of exclusivity.
"This provision could allow brand companies to make multiple minor changes to their products and receive 12 years for each change, in effect maintaining their monopolies in perpetuity," Jaeger maintained. "This practice, commonly known as evergreening, would essentially prevent safe and affordable lifesaving biogenerics from ever reaching patients."
Significantly, Senate staff members responsible for hammering out a final version of the legislation have assured GPhA that the intent of the compromise language is not to provide permanent patent protection for branded biologics. The association is hopeful that further revisions will clarify this issue.
"We are confident that working together in good faith with all stakeholders ? the Congress can and will produce a workable legal and regulatory pathway for biogenerics," Jaeger said. "None of us want to participate in a process that produces little more than an empty promise."