> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Drug Study Reassures on Product Quality
- URL: https://www.fdaweb.com/fda-drug-study-reassures-on-product-quality/
- Published: 2020-08-24T12:00:00.000Z
- Updated: 2026-09-14T16:26:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147495

A new FDA study of 252 difficult-to-make prescription pharmaceuticals found that the U.S.-marketed products “consistently meet quality standards even when manufactured outside the U.S.” Published in the *Journal of the American Medical Association Network Open*, [the study](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2769690?utm%5Fcampaign=FDA%20Publishes%20Study%20Analyzing%20Quality%20of%20Difficult-to-Make%20Pharmaceuticals%20Marketed%20in%20the%20US&utm%5Fmedium=email&utm%5Fsource=Eloqua) found that all 252 drug products the agency sampled met U.S. market standards for the major quality attributes of dosage unit uniformity and dissolution. “However, there is evidence of differences in the consistency of these attributes between regions and manufacturers,” it says.

The study found that while there has been skepticism about generic drug quality with products made in international facilities, the data suggest that “U.S. manufacturers made some of the generic drugs sampled here with comparable, if not slightly lower, consistency than Indian and Asian manufacturers. This suggests that geographic region alone is not a reliable indicator of quality.”

Additionally, FDA says the study highlights additional opportunities for regulatory outreach and scrutiny. “For example, it is widely thought that the pharmaceutical manufacturing industry operates between two to three sigma, well below other manufacturing industries,” it says. “Indeed, 11 manufacturers had dissolution cohorts falling below four-sigma manufacturing associated with dissolution. It is interesting to note that four of these 11 manufacturers have received FDA Warning Letters since the end of the sampling period, all associated with concerns about the reliability of data but unrelated to this study. Retrospective analysis suggests that process performance data may have some predictive power as manufacturers performing above median \[process performance index\] reported fewer quality problems (field alert reports) to the FDA after the end of the sampling period.”