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ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
Date:3/18/2009

for the new draft guidance expires on March 19, 2009. OGD has acknowledged the complexity of the issues involved, and specifically stated that the Agency will carefully consider all comments before responding to ViroPharma's Citizen Petition and finalizing BE recommendations for Vancocin.

"While we appreciate that the FDA has provided a limited level of public process, we continue to vehemently disagree with an approach that we believe places patient lives in the hands of an unproven method that is riddled with assumptions, and the result of a profoundly flawed process which could lead to sub-therapeutic versions of Vancocin," said Thomas Doyle, ViroPharma's vice president of strategic initiatives. "We reiterate our willingness to assist FDA in any way we can in the development of a rigorous method that will ensure the approval of safe and effective generic versions of Vancocin. We note in our comments that will we share the data from the ongoing study we are sponsoring at Temple University regarding the GI conditions to be found in patients with CDI, preliminary data from which indicate that CDI patients do not exhibit the healthy GI physiology asserted by OGD. We are also willing to provide FDA with unrestricted financial support for efforts aimed at developing a scientifically rigorous bioequivalence method for generic copies of Vancocin."

Some of the many points of concern over the draft BE Guidelines described in ViroPharma's submission include:

  • The December 2008 Draft Guidance method is not correlated with patient outcomes, as the law and good science require.
  • Documented examples repeatedly demonstrate OGD's poor judgment and bad faith in developing bioequivalence methods for Vancocin.
  • OGD has gone to great lengths to avoid any consideration of the actual environment in which Vancocin will be used - patients with infected GI tracts - t
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SOURCE ViroPharma Incorporated
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