US FDA And OMB Should ‘Pause’ Billion-Dollar Quality Metrics Program, Industry Groups Say
High projected cost and low perceived benefit merits further dialogue on US FDA's quality metrics initiative, industry coalition says. One group might tap into Trump administration's anti-regulatory view in advising budget office that compliance could cost industry $1bn per year. Groups question whether initiative could wind up causing drug shortages instead of preventing them.
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Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.
The US FDA used predictive analytics to mine data from 346 field alert reports to gauge the strength of manufacturers’ quality systems with the idea of using it to help set inspection priorities.
Agency agrees with those who prescribe and buy drugs on need to incentivize quality. Except providers want it yesterday.