Inspection Fees Face Tough Road In Congress As PhRMA Remains Opposed
At user fee hearing, PhRMA’s Wheadon counters questions from Rep. Dingell, saying FDA already is receiving resources to conduct GMP inspections outside the U.S.
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Senate is last step before the bill goes to the president; Rep. Dingell laments that legislators were “closer than ever before” on a tracking agreement but did not quite make it.
The type of incentive remains under consideration, but one suggestion is a grading system similar to what restaurants receive from local health departments.
The budget request targets an increase in pharmaceutical programs’ budget authority to boost the number of FDA staff focused on China’s manufacturing. The proposed $10 million increase, including $5.6 million to be allocated toward manufacturing, provides for additional inspections, educational efforts and inspectors in China.