HHS Inspector General Finds FDA Spends User Fees Appropriately
The US Department of Health and Human Services’ (HHS) Office of Inspector General on Thursday released a report finding that the Food and Drug Administration (FDA) generally spent prescription drug user fees appropriately.
Background
FDA is authorized to collect user fees from pharmaceutical and biotechnology companies seeking approval of certain human drug and biological products to expedite the review of applications.
Congress reauthorizes the user fee agreements every five years (the most recent one was passed in August), and FDA expects to use the user fees to meet goals set by industry and FDA for the timely review of applications.
OIG says its objective in creating this report was to determine whether FDA appropriately expended prescription drug user fees.
OIG Report
The report, which contained no recommendations and was based on more than $796 million in user fees collected by FDA between 1 October 2014 and 30 September 2015, comes on the heels of Tom Price’s recent resignation as HHS secretary because of questions raised over his use of taxpayer funds for luxurious travel, though it’s unknown if he will reimburse HHS for those expenditures.
Sen. Patty Murray (D-WA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) committee, recently sent a letter to Treasury Secretary Steven Mnuchin seeking confirmation on whether or not Price has reimbursed the treasury for his chartered travel expenses.
For FDA, the OIG found the agency “did not have adequate supporting documentation for $6,403 in travel expenses, made a duplicate payment for airfare of $1,213, and overpaid a traveler $587.”
But FDA recovered the duplicate payment and overpayment from the travelers during OIG’s review, and the lack of supporting documentation appeared to be an oversight by FDA staff and not a systemic issue, OIG said.