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Congress Acts to Protect Public Health this Flu Season

June 27, 2013
The next flu season may be months away, but Congress already acted to ensure our nation is ready.

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Reps. Jim Gerlach (R-PA) and Richard Neal (D-MA), as well as Sens.  Max Baucus (D- MT) and Orrin Hatch (R-UT) introduced legislation which was recently enacted into law (H.R. 475) to update the National Vaccine Injury Compensation Program (VICP) to cover the newest flu vaccines in time for flu season, ensuring patient access to the latest therapies.

Recently in the press, some have claimed that this represents a "new tax" on vaccines. Nothing could be further from the truth. Vaccine taxes are already levied on vaccines to fund the VICP, and they have been for decades. This legislation allows the existing tax to be applied to the newest vaccines so that they are covered by the VICP.

Each year, a different flu vaccine is produced to keep pace with the rapidly adapting flu virus. Because flu viruses evolve so quickly, last year's vaccine won't protect against this year's flu. In January, labs across the globe began prepping for the flu vaccine, seeking to determine which flu strains should be targeted this year.

On February 27, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) selected the appropriate strains to be included in vaccines for the 2013-14 flu season. However, this year, the committee selected four strains rather than three. The vaccines, known as a quadrivalent influenza vaccines, were recently approved by the FDA.

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.

To fund the VICP, an excise tax is levied on each dose of vaccine recommended for children by the Centers for Disease Control (CDC).  The amount – 75 cents per flu vaccine– will not change under this legislation.  Because of enactment of H.R. 475, the law will now allow for the tax to be levied on four-strain vaccines.  Such vaccines were not scientifically possible when the law was enacted, so the law needed to be technically updated to include the new vaccine options.

According to the CDC, a four-strain vaccine could have prevented nearly three million flu cases and 1,400 flu-related deaths over the past ten flu seasons.

Christopher P. Molineaux is the president of Pennsylvania Bio.

Pennsylvania Bio is the only statewide trade association for the life sciences in Pennsylvania and serves as a catalyst to ensure Pennsylvania is the global leader in the biosciences by creating a cohesive community that unites our biotechnology, medical device, diagnostic, pharmaceutical, research, and financial strengths. More information is available at