2009 is shaping up to be a big year for debate on Follow-On Biologics (“FOBs”). Earlier this year, Representative Anna Eshoo introduced FOB legislation and the House Energy and Commerce Committee Subcommittee on Health requested comment on various FOB issues. The legislation and comments submitted in response to the subcommittee’s request are expected to provide a platform for debate in the 111th Congress – once it convenes in January 2009. Now the Federal Trade Commission (“FTC”) plans to weigh in on the issue – from a competition perspective.
On August 27, 2008, the FTC announced plans to hold a workshop concerning “competition provided by developing an abbreviated regulatory approval pathway for follow-on biologic drugs.” According to the FTC’s Federal Register notice, a date for the workshop has not yet been set, but the FTC plans to issue a report in spring 2009 analyzing the potential impacts on the marketplace of FOBs. As part of the FTC’s analysis, the Commission requests comment on two sets of questions (18 questions in all). The first set deals with regulatory exclusivities and FOB competition and focuses on “whether, or to what extent, these regulatory incentives should be adopted in creating a pathway” for FOB approval. The second set concerns patent dispute resolution issues and asks, among other things, about the lessons that have been learned from Hatch-Waxman incentives to encourage early resolution of patent issues.
In what might be a sign of the FTC’s recommendation in any report that is issued, it is noteworthy that earlier this year, the Commission submitted a letter to the House Energy and Commerce Committee Subcommittee on Health noting that “Congress should consider the risks and rationales of establishing a period of generic exclusivity in the context of biologics,” and that:
to the degree Congress determines that exclusivities to branded or generic companies are beneficial, it should limit companies’ ability to game those exclusivities at the expense of consumers by (1) disconnecting the FDA approval process for generic biologics from patent litigation, and (2) ensuring there is no opportunity for brands effectively to lengthen their exclusivities through insignificant changes to a branded biologic product or through excessive procedural delays.
In addition, in June 2007, FTC Commissioner Pamela Jones Harbour stated during a speech that “it would be incorrect to assume that Hatch-Waxman [patent and exclusivity benefits] can simply be imported from the pharmaceutical realm to biologics. There are too many critical differences . . . . For example, I would be very skeptical of a follow-on biologic approval pathway that included an Orange Book-like system of patent listings.”