By Donald Zuhn --
On Friday, the House Committee on Energy and Commerce approved a health care reform bill by a narrow three-vote margin (31-28). The bill (H.R. 3200), entitled "America's Affordable Health Choices Act," was originally introduced in the House on July 14, 2009 by Rep. John Dingell (D-MI).
According to a statement released by the Committee, the bill will "build on what works in today's health care system, makes important insurance market reforms to protect consumers, encourages competition among insurance plans to improve choices for patients, and expands access to quality, affordable health care for all Americans." Committee Chairman Henry Waxman (D-CA) called the passage of the bill "a historic moment for the House of Representatives and a defining moment for our country," adding that the bill "will deliver the results the nation's health care system so desperately needs: lower costs, better quality, and broader coverage." Chairman Waxman said that he hoped that the House would pass the bill when it returns from recess. The Energy and Commerce Committee's bill will be merged with provisions reported by the Committees on Ways and Means and Education and Labor for consideration by the full House of Representatives.
The Committee also announced a series of mark-ups to the bill that were introduced prior to the Committee's vote. One of the mark-ups was an amendment offered by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) that is similar to the follow-on biologics legislation (H.R. 1548) Rep. Eshoo (at left) introduced in March. In particular, the amendment outlines a licensure pathway for biosimilar biological products that includes a provision preventing the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed. The amendment was passed by the Committee by a comfortable 41-11 margin. Voting against the amendment were Chairman Waxman and Representatives Dingell, Frank Pallone, Jr. (D-NJ), Lois Capps (D-CA), Janice Schakowsky (D-IL), Anthony Weiner (D-NY), Kathy Castor (D-FL), John Sarbanes (D-MD), Betty Sutton (D-OH), Peter Welch (D-VT), and Nathan Deal (R-GA). The votes by Representatives Pallone, Capps, Schakowsky, and Sarbanes were not altogether surprising, given that the four Committee members are co-sponsors of Chairman Waxman's H.R. 1427, which provides up to 5.5 years of exclusivity (as of Friday, Chairman Waxman's bill had the support of 14 co-sponsors while Rep. Eshoo's bill enjoyed the support of 142 co-sponsors).
The Committee's passage of H.R. 3200 marked the second victory this month for organizations, trade groups, and companies seeking a longer (12 to 14-year) exclusivity period. On July 14, 2009, the Senate Health, Education, Labor and Pensions (HELP) Committee approved -- by a 16-7 vote -- an amendment providing a 12-year exclusivity period for biologic drug makers (see "Senators Hatch and Enzi Champion 12-Year Data Exclusivity in Senate").
In a statement released by the Biotechnology Industry Organization (BIO), BIO President and CEO Jim Greenwood observed that "[t]he strong bipartisan support in the Energy and Commerce Committee for a fair and balanced pathway for the approval of biosimilars is a decisive win for the patients of today and tomorrow," and contended that the Eshoo-Inslee-Barton amendment "strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical innovation." Mr. Greenwood noted that the amendments approved this month in both the House and Senate Committees had the support of the ALS Association, Alliance for Aging Research, Association of American Universities, National Venture Capital Association, AIDS Institute, National Minority AIDS Council, Children's Tumor Foundation, National Kidney Foundation, and Vietnam Veterans of America.