Representatives Oppose President's Attempt to Reduce Data Exclusivity Period

By Donald Zuhn --

Last week, 51 members of the House of Representatives sent a letter to President Obama, opposing the President's continued efforts to reduce the data exclusivity period under the Approval Pathway for Biosimilar Biological Products section of the Patient Protection and Affordable Care Act (PPACA).  The President's latest attempt at reducing the data exclusivity period came last month, when he released his plan for economic growth and deficit reduction, which included a proposal to "award brand biologic manufacturers seven years of exclusivity rather than 12 years under current law" (see "President's Deficit Reduction Plan Seeks to Reduce Exclusivity Period for Biologics and Prohibit Pay-for-Delay Deals").

In their letter, the House legislators noted that the biosimilars regulatory pathway of the PPACA had "overwhelming bipartisan and bicameral support."  As indicated in the letter, amendments to the health care reform bill providing a licensure pathway for biosimilar biological products were passed 47-11 by the House Energy and Commerce Committee (see "House Committee Approves Health Care Reform Bill Calling for 12-Year Exclusivity Period") and 16-7 by the Senate Health, Education, Labor and Pensions (HELP) Committee (see "Senators Champion 12-Year Data Exclusivity in Senate").

The Representatives contend that because biologic drugs can be expensive, an approval pathway was needed in order to put generic options within reach of patients.  The authors argue, in fact, that the biosimilar regulatory pathway of the PPACA "was the single most significant provision in the Affordable Care Act to lower the cost of drugs in our country."  However, the letter explains that "[t]o establish a new pathway, it was critical to balance the need for patient access with incentives for innovation," noting that "[t]oo much protection for an innovator would leave patients with high-costs; too little protection, and innovators would leave the U.S. for friendlier regulatory environments like the European Union."  According to the legislators, the biosimilar regulatory pathway of the PPACA "struck that balance by establishing 12·years of data exclusivity for the innovator product."  In support of this assertion, the letter notes that the Congressional Budget Office (CBO) determined that 11.5·years is the average period of time all drugs are marketed under patent.

The letter also notes that "[i]t's important to remember that the pathway established in the Affordable Care Act reduced the years of data exclusivity for biologics from infinity to 12-years" (emphasis in original), adding that this reduction will reduce the cost of healthcare by $6 billion over the next ten years.  The Representatives argue that the President's proposal to reduce the data exclusivity period from 12-years to 7-years "will undermine the legislation, leaving Americans in the dust," and they predict that as a result, "[b]iotechnology companies will move overseas where other regulatory environments, like the European Union, recognize the importance of fostering innovation" (emphasis in original).  The letter concludes that "[t]welve years of data exclusivity for biologics is settled United States law," adding that "[r]epeated attempts to weaken this provision, and for a time period with no legitimate basis, [are] unacceptable" (emphasis in original).  (The letter's reference to repeated attempts likely refers to the President's economic growth and deficit reduction plan as well as his 2012 budget, unveiled in February, which specified that the exclusivity period be reduced to 7 years (see "President's Budget Proposal Increases Funding for Basic Research But Seeks to 'Trim' Data Exclusivity Period and Pay-for-Delay Agreements").)

The 51 House members who signed the letter were Representatives Anna Eshoo (D-CA), Joe Barton (R-TX), Jay Inslee (D-WA), Leonard Lance (R-NJ), Joe Pitts (R-PA), Donna Christensen (D-VI), Gene Green (D-TX), G.K. Butterfield (D-NC), Joe Courtney (D-CT), John Larson (D-CT), John Campbell (R-CA), Charlie Gonzalez (D-TX), Laura Richardson (D-CA), Michael Capuano (D-MA), Howard Coble (R-NC), James McGovern (D-MA), Tammy Baldwin (D-WI), Robert Brady (D-PA), Zoe Lofgren (D-CA), Michael Honda (D-CA), Jim Matheson (D-UT), Edward Markey (D-MA), Mike Thompson (D-CA), Dutch Ruppersberger (D-MD), Jackie Speier (D-CA), Michael Michaud (D-ME), Brian Bilbray (R-CA), Gary Peters (D-MI), Susan Davis (D-CA), Martin Heinrich (D-NM), Robert Latta (R-OH), Rush Holt (D-NJ), Doris Matsui (D-CA), Loretta Sanchez (D-CA), Bill Pascrell (D-NJ), Jim Himes (D-CT), Michael Burgess (R-TX), Gerald Connolly (D-VA), Jason Altmire (D-PA), Joe Crowley (D-NY), Jerry McNerney (D-CA), Barney Frank (D-MA), Ron Kind (D-WI), Richard Neal (D-MA), Chris Murphy (D-CT), John Barrow (D-GA), Adam Smith (D-WA), Chaka Fattah (D-PA), Bruce Braley (D-IA), Sam Farr (D-CA), and Mary Bono Back (R-CA) -- a total of 42 Democrats and 9 Republicans.

Comments

[Dan Feigelson]

Lamar Smith, Henry Waxman and Xavier Becerra didn't sign? Shocking.