FDA has indicated that ViroPharma can expect the opportunity for public input regarding bioequivalence methods for Vancocin, but has not yet committed to a next step. Commented Colin Broom, M.D., ViroPharma's vice president, chief scientific officer, "We are encouraged that FDA appears to be taking the first step toward a public process to consider the development of bioequivalence methods for locally acting drugs that treat gastrointestinal conditions. After the general discussion at the July 23rd Advisory Committee meeting, FDA should be better prepared to conduct a public process on bioequivalence methods for Vancocin specifically. ViroPharma is prepared to participate in that process when the time comes. We have long contended that changes in GI physiology observed in patients with Clostridium difficile infection make healthy gut bioequivalence models inapplicable to drugs, like Vancocin, which treat this condition."
ViroPharma has previously explained in various submissions to FDA that
appropriate public process for development of bioequivalence methods
specifically for Vancocin should include (1) public proposal of the method
and the data FDA believes validate that method; (2) FDA receipt of and
response to public comments on the proposed method; (3) consideration by
the appropriate FDA Advisory Committees, including the Advisory Committee
for Pharmaceutical Science and Clinical Pharmacology; and (4) final
decision making on whether to adopt the method by neutral scientific and
medical experts, not the FDA personnel who originally proposed the method.
ViroPharma continues to believe that bioequivalence for Vancocin is
deserving of at least the same level of process and scientific discussion
|SOURCE ViroPharma Incorporated|
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