Making unsubstantiated and/or false claims by the regulatory authorities including FDA regarding quality of pharmaceutical products

In a recently published article (link), titled “FDA Q&A: Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices” by a Senior Science Advisor, responding to a question regarding concerns expressed in a recently published book, the author of the article claims that “…Americans can be confident in the quality of the products the FDA approves.”

It is to be noted that the claim made by the FDA cannot be considered truthful and/or scientifically valid. The reason being that at present quality of the products, in particular tablet and capsule, has not be defined, thus cannot be measured or established. Furthermore, meeting compliance requirements as a substitute of “quality”, which in most cases are arbitrary, lacks validation of the suggested methods and/or procedures (both in vitro and in vivo) for their relevancy and accuracy for their intended purpose or claims (link).

It is, therefore, requested that the FDA should reconsider its claims and approaches for declaring products of having quality, and by extension safe and efficacious.

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