HHS Inspector General Finds FDA Spends User Fees Appropriately

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HHS Inspector General Finds FDA Spends User Fees Appropriately[size=1.25em]Posted 05 October 2017By Zachary Brennan

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 secretarybecause 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.

THE FOOD AND DRUG ADMINISTRATION GENERALLY SPENT PRESCRIPTION DRUG USER FEE COLLECTIONS APPROPRIATELY

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审计结果：
RESULTS OF REVIEW FDA
generally spent prescription drug user fee collections appropriately. However, FDA 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. FDA recovered the duplicate payment and overpayment from the travelers during our review. The lack of supporting documentation appeared to be an oversight by FDA staff and not a systemic issue. Accordingly, this report contains no recommendations
美国FDA还是挺难的，除了受上面的HHS内部审计局（office of inspetor general）审计，还要经常受美国审计总署（GAO）审计，几千块钱的不合理账务还要在检查期间及时解决。

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