The OIG has issued a report on “FDA’s Approval Status of Drugs Paid for by Medicaid.” According to the OIG, 38% of drugs paid for by Medicaid in 2008 – accounting for 25% of expenditures — did not have an approved application number listed in the National Drug Code (NDC) Directory or were not in the NDC Directory at all. The OIG notes that “without accurate approval and listing information, it is impossible to determine whether these drugs were paid for appropriately,” and Medicaid could potentially pay for drugs that are not approved by FDA. The OIG recommended that FDA: (1) conduct frequent reviews of its NDC Directory to ensure its completeness and accuracy, and (2) work with CMS and Congress to seek a legislative or regulatory change that compels manufacturers to list all approved products with FDA before they become eligible for Medicaid payment. The FDA generally agreed and stated that it is working on several strategies for evaluating and correcting drug-listing data.