For example:
FDA claims that it establishes and monitors the quality of pharmaceutical products such as tablets and capsules. A lie – FDA neither defines the quality of the products nor its measurable parameter; hence it does not, or cannot, determine the quality of the products.
FDA claims that it establishes the safety and efficacy (as well as quality) of pharmaceutical products using valid clinical testing (e.g., bioequivalence assessment) and in vitro (drug dissolution) testing using USP apparatuses. Again, a lie – these tests and associated testers have never been validated for the intended purpose. In fact, these tests are scientifically invalid and irrelevant for their intended purpose.
USP claims that it provides reference standards for establishing the quality of the pharmaceutical products such as tablets and capsules. A lie – USP never provides reference standards for any product. It provides powder or liquid samples of pure chemical compounds, not the products which patients use. However, it falsely promotes reference standards of medicines.
USP claims that it provides a valid analytical test for assessing drug release characteristics of the products for establishing and monitoring the quality of the products. A lie – the test has never been validated for the intended purpose. The test cannot determine the drug dissolution/release characteristics of any product. It has been shown experimentally that the test provides irrelevant and highly unpredictable results/data with no relevance to product quality.
For more examples, please visit here and here. Manufacturers and patients should be cautious in accepting such claims from FDA and USP and other national and international authorities, which often follow FDA/USP claims and guidances.
Please consider accepting the Citizen Petition (under review with FDA for more than a year and a half, link) to address the underlying lies concerning products development, manufacturing, and their regulatory approval.