By Donald Zuhn --
Reuters reports that the White House sent a letter to Rep. Henry Waxman (D-CA), the Chairman of the House Energy and Commerce Committee, on Thursday stating that a follow-on biologics regulatory pathway providing a 7-year data exclusivity period would "strike the appropriate balance between innovation and competition." According to the Reuters report, the letter was signed by Peter Orszag, Director of the Office of Management and Budget (OMB), and Nancy-Ann DeParle, director of the Office of Health Reform.
Three follow-on biologics bills have been introduced in the 111th Congress so far: H.R. 1427, which was introduced by Rep. Waxman on March 11 and which provides up to 5.5 years of data exclusivity; H.R. 1548, which was introduced by Rep. Anna Eshoo (D-CA) on March 18 and which provides up to 14.5 years of data exclusivity; and S. 726, which was introduced by Sen. Charles Schumer (D-NY) on March 26 and which is the Senate companion to H.R. 1427. With respect to the two House bills, a search of thomas.gov indicates that H.R. 1427 currently is backed by 12 co-sponsors and H.R. 1548 enjoys the support of 107 co-sponsors.
According to the Reuters report, Rep. Waxman (at left) stated that the Obama administration "has made clear that the president does not support the lengthy monopoly periods sought by the drug industry and instead wants a bill, as I do, that will bring real competition and will not unduly prolong the monopolies on biotech drugs."
In a statement issued by the Biotechnology Industry Organization (BIO), President and CEO Jim Greenwood said that while BIO "continues to support strongly the development of a pathway for the review and approval of biosimilars," the organization was "extremely concerned that the seven years of data exclusivity called for by the administration in the letter points to a risky short cut to biosimilars." He added that BIO "believe[s] this abbreviated period will undermine the incentives necessary for continued biotech research into breakthrough medicines and cures for diseases such as cancer, multiple sclerosis, Alzheimer's and HIV/AIDS as well as unmet medical needs," and that "any pathway to biosimilars should provide a fair period of time for innovators to protect their proprietary data from competitors in order to promote the continued development of breakthrough medicines, therapies and cures."
Mr. Greenwood (at left) stated that BIO "continue[s] to believe that fourteen years of data exclusivity will strike the appropriate, reasonable and fair balance between our common desire to expand access to breakthrough biotech medicines and the need to preserve the protections necessary to promote further biomedical advances." He also noted that the bill providing such a period, H.R. 1548, enjoyed the support of more than 100 House co-sponsors as well as the support of "more than 105 patient advocacy, physician, academic and innovator groups."
Mr. Greenwood said that BIO was "disappointed the administration chose to base its policy upon the Federal Trade Commission (FTC) report," which he argued "was based upon highly selective assumptions and has been rejected by many members of Congress as fundamentally flawed" (see "No One Seems Happy with Follow-on Biologics According to the FTC"). The BIO release asserts that "[f]ollowing the recommendations in the report will place at risk the more than 7.5 million high wage, high-quality American jobs supported by the biotech industry and jeopardize our nation’s global competitive advantage in biomedical innovation."
For additional information on this and other related topics, please see:
• "Future Drug Sales Predictions Highlight Importance of Follow-on Biologics Legislation," June 21, 2009
• "AEI Believes Advantages of Longer Data Exclusivity Period Outweigh Disadvantages," June 18, 2009
• "No One Seems Happy with Follow-on Biologics According to the FTC," June 14, 2009
• "Uncertain Future for Waxman Follow-on Biologics Bill," June 9, 2009
• "CHI CEO on Patent Reform and Follow-on Biologics Legislation," April 28, 2009
• "Follow-on Biologics in the News - No. 3," April 27, 2009
• "Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics Legislation," April 22, 2009
• "Third Follow-on Bioligics Bill Introduced in 11th Congress," April 1, 2009
• "Second Follow-on Biologics Bill Is Introduced in House," March 18, 2009
• "Waxman Introduces Follow-on Biologics Bill," March 11, 2009
• "Former House Ways and Means Economist Claims 7-Year Data Exclusivity Period Is Sufficient," November 20, 2008
• "BU Economics Professor Releases Report on the Impact of Marketing Exclusivity on Biologics Innovation," Sptember 18, 2008