Building Consumer Confidence in Generic Medicines: Expert Insights on Quality Assurance

Ed covers prescription drug pricing, affordability, and access, along with related patent, litigation, and legislative issues. He also writes the morning Pharmalittle and afternoon Pharmalot newsletters.

For years, generic medications have made up about 90% of prescriptions filled in the United States due to their lower cost. However, consistent supply remains challenging because of variable quality—more than 60% of generic drug shortages stem from quality problems, according to the U.S. Food and Drug Administration. Many manufacturers, especially those based in India, have faced citations for breaking production standards, leading to recalls and, at times, bans on exporting their products to the U.S.

Kevin Schulman, a professor and deputy director of Stanford’s Clinical Excellence Research Center, believes a viable solution exists. Having collaborated with the independent lab Valisure—which uncovered contaminants in several widely used drugs—he advocates that the FDA promote testing by independent, accredited laboratories.

We recently interviewed Schulman on this topic; below is an edited excerpt of our discussion.

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