AboutMichael Anisfeld Expertise Disclaimer:
SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT).
My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements
Experience
Past/Present Clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
Question Are you aware, that by law, generic drugs do not have to bioidentical? Meaning they can contain less than 100% of the brand name drug.
When people say that the generic form of the brand doesn't seem as effective, they are completely right. They are not psychosomatic.
Check out the FDA's ruling on generic drugs if you don't believe me.
Answer Lori:
Sorry, but I completely disagree with you.
According to the Good Manufacturing Practices Regulations (21CFR211), all drugs must be manufactured to 100% of label claim. A generic company (or a brand manufacturer) would be breaking the law to formulate for say 95% of labeled potency.
Additionally a generic manufacturer must prove scientifically that the generic drug has identical bio-availability and bio-equivalence to the originator (brand name) drug, for the generic to be approved for sale by FDA.
What may be different is the excipients, shape and color of the generic, but not the bio-availability and bio-equivalence; and the shape and color are irrelevant to the drugs performance.
I make the above comments having consulted with brand name and generic drug companies on drug quality for the past 20 years.
