The FDA may create a rating system for drugmakers' manufacturing facilities as a strategy to combat drug shortages, according to STAT.
The agency hopes the ranking system will incentivize drugmakers to consistently make drugs that meet quality standards and therefore reduce some of the quality issues that lead to shortages.
"Unfortunately, incentives today are not high enough for many manufacturers to establish mature quality management capabilities," Janet Woodcock, MD, the head of the FDA Center for Drug Evaluation and Research wrote in an article. "As a result, drug manufacturers are more likely to keep costs down by minimizing investments in manufacturing quality, leading to quality issues that can trigger supply disruptions and shortages of needed medications."
Under the rating strategy, the FDA envisions that drugmakers could disclose their ratings at their own discretion as a "competitive advantage." The agency said that group purchasing organizations also may require the ratings to be disclosed in their contracts with drugmakers.
Drugmakers have not yet voiced an opinion on the FDA's proposal.
David Light, the CEO of Valisure, an online pharmacy that tests drugs before shipping them to customers, told STAT that focusing on a self-reported rating misses the point.
He added that a rating system should be based on real, chemical quality data and come from independent entities outside of the Good Manufacturing Prices system, which sets quality standards for drug development.
Read the full article here.