FTC Commissioner Speaks Out on Follow-On Biologics – Current Initiatives and Long-Term Goals

November 4, 2008

By Kurt R. Karst –      

Commissioner Pamela Jones Harbour of the Federal Trade Commission (“FTC”) recently gave a speech, titled “The Federal Trade Commission’s Perspective on Biosimilars: Current Initiatives and Long-Term Goals.”  This is at least the second speech in which Commissioner Harbour has address the topic of Follow-On Biologics (“FOBs”).  In June 2007, she gave a speech, titled “The Competitive Implications of Generic Biologics,” in which she stated her hope and expectation that the FTC would play an important role in the debate over FOBs.

Commissioner Harbour’s recent speech largely follows up on the FTC’s May 2, 2008 comments provided in response to an April 3, 2008 letter from the House of Representatives Energy and Commerce Committee Subcommittee on Health.  As we previously reported, the letter was sent a to a diverse group of  stakeholders soliciting feedback on how to establish a pathway to allow FDA to approve FOBs.  The FTC’s response and Commissioner Harbour’s recent comments focus primarily on the lessons that can be learned from experience with the Hatch-Waxman Amendments and caution Congress to take care to avoid any “unintended consequences” that could limit or eliminate the benefits of any FOB legislation.  

Commissioner Harbour’s recent speech also follows up on the FTC’s recent announcement and Federal Register notice on the Commission’s plans to hold a workshop concerning “competition provided by developing an abbreviated regulatory approval pathway for follow-on biologic drugs.”  The workshop is scheduled to take place on November 21, 2008 in Washington, D.C.  The FTC plans to issue a report in spring 2009 analyzing the potential impacts of FOBs on the marketplace. 

In her recent remarks, Commissioner Harbour states that “the Commission supports the development of an abbreviated approval pathway for follow-on biologics, balanced by an appropriate recognition of consumer safety and incentives to innovate,” but cautions that “policymakers should tread carefully, to ensure they fully understand the likely competitive implications and long-term consequences of their decisions.”

Categories: Drug Development