As quality issues remain as the main reason drugs fall into shortages, the FDA unveiled a plan to incentivize drugmakers to invest in quality measures, according to a white paper.
The FDA will test and refine the quality management maturity program in 2024. The QMM won't analyze product quality but will assess drug manufacturers' processes, including a company's commitment to quality, protocol to minimize supply disruptions, advanced pharmaceutical quality systems, technical excellence and employee engagement.
Pharmaceutical supply experts have long pushed for agencies to assess and publish quality metrics for drugmakers in an effort to quell harm from drug shortages.
The FDA said it plans to "recognize establishments that have advanced quality management practices and acknowledge establishments that strive to continually improve quality management practices," as well as "identify areas where quality management practices can be enhanced and provide suggestions for growth opportunities," according to the white paper.