House Commerce Committee Posts Responses to its Questions on Biogenerics; Not Surprisingly, the Views Run the Gamut

June 19, 2008

On April 3, 2008, Representatives Frank Pallone, Jr., (D-NJ), Chairman of the House Energy and Commerce Committee Subcommittee on Health, and Nathan Deal (R-GA), ranking Republican of the Subcommittee on Health, sent a letter to a diverse group of 35 stakeholders, such as AARP, PhRMA, GPhA, and General Motors, soliciting feedback on how to establish a pathway to allow FDA to approve so-called biogenerics.  According to the letter:

Members of the Subcommittee on Health are committed to [creating a biogenerics pathway] and several have introduced legislation to establish an abbreviated approval process.  We have found it challenging, however, to reach consensus on a single bill that would accomplish this goal.  In order for the Subcommittee to better evaluate the merits, benefits, and costs of a biosimilars bill, we wish to understand more fully the range of perspectives, concerns, and objectives that might be addressed in such a legislative proposal.  We are also interested as to where consensus exists within the biotechnology community and among other stakeholders.

Earlier this year, Rep. Anna Eshoo (D-CA), who is a member of the Subcommittee on Health, introduced the Pathway for Biosimilars Act (H.R. 5629).  In February 2007, Rep. Henry Waxman (D-CA), who is also a member of the subcommittee, introduced the Access to Life-Saving Medicine Act (H.R. 1038).  Energy and Commerce Committee member Jay Inslee (D-WA) also introduced a bill in April 2007 – the Patient Protection and Innovative Biologic Medicines Act of 2007 (H.R. 1956).  None of these bills have moved very far along in the legislative process.  Although there was speculation earlier this year that Congress might pass legislation before the conclusion of the 110th Congress, that now seems highly unlikely.  Instead, this issue will probably be taken up by the 111th Congress when it convenes in January 2009.  Nevertheless, stakeholder feedback on the Subcommittee on Health letter could help Congress craft a consensus bill.

The April 2008 Subcommittee on Health letter includes 6 pages of questions divided among several general areas, including science/safety, regulatory/administrative, interchangeability, patents, incentives/exclusivity/investment, and economic impact.  Earlier this week, the Subcommittee on Health announced the availability of the stakeholder responses.  The stakeholder responses provide a wide range of views on the topic of biosimilars.  For example, the Association of American Universities suggests that “the proposed legislation should avoid the unintended consequence of encouraging patent challenges that unnecessarily involve our researchers in patent litigation, diverting institutional resources away from scientific research,” and that “[t]he longer the data exclusivity period, the more likely it is that a university’s patent will expire before FDA approval of the biosimilar, and thus the less reason for [a biogeneric] applicant to challenge the university’s licensed patents.”  Conversely, GPhA “believes that five-year market exclusivity, along with intellectual property and the patent restoration provisions included in the Hatch-Waxman amendments, provides a reasonable balance between innovation and access and should be used for biogenerics.”  Clearly, as Congress moves forward on biogenerics there will be no dearth of debate on the various issues they raise. 

By Kurt R. Karst

Categories: Drug Development