On August 6, 2009, WLF filed brief comments with the Food & Drug Administration (FDA) Transparency Task Force regarding the ongoing lack of transparency and accountability in determinations made by FDA’s Office of Generic Drugs (OGD) as to whether a generic applicant’s product is sufficiently similar to the reference listed drug on which it is based. It is WLF’s opinion that in order to improve the public’s confidence in the equality of generic drugs, FDA decision-makers must utilize strict standards and be accountable to established checks and balances.
