FDA's latest article: The quality and origin of the drug does not matter.

A quality study conducted by the FDA found that sample tests for more than 200 hard-to-produce drugs met U.S. standards for dose unit uniformity and solubility.
August 24, the FDA published its findings in the Journal of the American Medical Association (JAMA), entitled "Quality Testing of Difficult Prescription Drug Products Sold in the United States."
: Are there material differences in the main quality attributes of difficult drugs produced worldwide and sold in the United States? RESULTS: In this quality improvement study, all 252 drug samples met the relevant standards of the U.S. market, despite evidence of differences in the consistency of key quality attributes such as dose unit uniformity and solubility across regions and manufacturers.
: These findings show that difficult prescription drugs sold in the U.S. consistently meet quality standards, even when manufactured outside the U.S.
's confidence in the quality of prescription drugs is by far the largest test of its kind, taking 252 products, including 35 innovative drugs and 217 generic samples.
these products contain a total of 17 different APIs with samples from 46 companies.
, of the FDA's Drug Assessment and Research Center (CDER), and colleagues examined drugs from the United States, Canada, Europe, India and other parts of Asia.
say the study is important because for patients and their caregivers, "information must be available to support their confidence in the quality of prescription drugs." figure
: Samples of 252 drugs registered with the FDA: Percentage by region at the production site (from left to right: Asia, Canada, Europe, India and the United States) Fisher and his colleagues say: "Some medical providers have been questioning the quality of certain drugs, and now it appears that their evidence is limited or hearsay".
Fisher cites a new survey of health care providers that points to "biases related to the quality of medicines."
In the survey, three-quarters of health care providers either did not know or were unsure whether they could believe that "drugs manufactured outside the United States and legally sold in the United States comply with FDA requirements, i.e. strict production standards and regulations."
found similar figures reported that patients' demand for branded drugs prompted them to emphasize designated drugs in their prescriptions.
quality meets the requirements All products sampled are in accordance with the U.S. Pharmacopeia dosage uniformity and solubility standards.
, there are 11 different manufacturers whose product solubility is below the 4 degree capacity level standard.
samples are less than 4 s, which means there will be more than one error out of 1,600 products, and these generic samples come from four of the five sample areas, including the United States.
: The correlation between the solubility and dose unit uniformity of each API in each sample and the defect report Fisher and his co-authors also performed a retrospective analysis of the study data.
For solubility or dose versus normality, there are also relatively few product quality defect reports submitted for manufacturers whose sample results are higher than Ppk's medium: on-site alert reports for solubility problems: producers with high Ppk values have an average quantity of 0.22;
on-site alert report for dose unit uniformity: producers with high Ppk values have an average quantity of 0.63, and for producers with low Ppk values, the average number is 1.7.
Products with the greatest fluctuations in solubility In this study, rapid-release solid oral preparations included antibiotic hypertension drugs such as amosillin, amoxilin in potassium claviate tablets, such as metformin and hydrochlorophosphonate diabetes and other cardiovascular drugs such as metformin and simvastatin, among which the most volatile fluctuations were found in products containing amoxicillin, hydrochlorin, pvastatin, simvastatin and venlafasin.
FDA said it would step up monitoring of stability data for these products.
Proflight of product quality is not related to origin The authors observe that "some conclusions may be drawn from these data, which is inconsistent with the usual bias", noting that Indian and Asian producers are similar in production consistency to between US producers.
: Process performance indicators (Ppks) of solubility and dose unit uniformity in different groups, indicating that geographical regions alone are not reliable indicators of quality.
(four sample groups are defined here with low solubility limits: 70%, 75%, 80% or 85%, respectively)"