Washington, DC (June 20, 2013) – The Biotechnology Industry Organization (BIO) applauds Sens. Max Baucus (D-MT) and Orrin Hatch (R-UT) and Reps. Jim Gerlach (R-PA) and Richard Neal (D-MA) on the passage of H.R. 475 to update the existing excise tax to cover the newest seasonal influenza vaccines.
The excise tax on seasonal influenza vaccines helps fund a no-fault compensation program for those injured by covered vaccines. The vaccine excise tax law must be updated to include the newest FDA-approved seasonal flu vaccines.
Currently, the law which imposes the excise tax on seasonal influenza vaccines applies only to trivalent (3-strain) vaccines, and excludes any non-trivalent vaccines. In February, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) selected the appropriate strains for the 2013-14 influenza season, including a fourth strain for quadrivalent vaccines. The first quadrivalent (4-strain) influenza vaccine was approved by the FDA in December 2012 and two other vaccines have been approvedsince that time. Without coverage by the VICP, the newest vaccines would not be as widely-available as otherwise.
So that any adverse events associated with the new seasonal flu vaccines will be covered by the national Vaccine Injury Compensation Program (VICP), the law that assesses the excise tax must be updated to include them.
The following can be attributed to BIO President and CEO, Jim Greenwood:
“This is an extremely important public health matter. Updating the vaccine excise tax to bring it into alignment with the newest developments in the vaccine market is critical to addressing the upcoming influenza season.
“The VICP was established after many manufacturers left the vaccine market due to litigation concerns. The VICP is a no-fault alternative to the traditional tort system for resolving vaccine injury claims that provides compensation to people found to be injured by certain vaccines. The existence of the VICP has allowed for continued innovation in the vaccine market over the past 25 years.
“Sens. Baucus and Hatch and Reps. Gerlach and Neal should be applauded for their efforts to ensure that the newest flu vaccines will be covered by the VICP in time for flu season, ensuring patient access to the latest therapies.”
Since the enactment of the initial excise tax legislation for the diphtheria-tetanus-pertussis (DTP), measles-mumps-rubella (MMR), polio, and tetanus vaccines, Congress has enacted legislation to place an excise tax on seven additional vaccines. These vaccines target prevention of the following diseases: hepatitis B, rotavirus, pneumococcal pneumonia, hepatitis A, seasonal influenza, meningococcal, and human papillomavirus (HPV).
Now that the new 4-strain flu vaccines are allowed to be covered under this important program, the tax on the flu shot will still be 75 cents, which is the same level as the tax last flu season.
According to the CDC analysis of 10 flu seasons, a 4-strain vaccine could have prevented nearly three million flu cases and 1,400 flu-related deaths.
More information on vaccines can be found at www.bio.org.