Revoking FDA Approval: Right or Wrong? - Part V

Now let's look at the players who influenced the FDA's decision to revoke approval of Avastin for breast cancer. The complex process requires a book-length manuscript to fully explain. Rather than abandon my effort, here are the bare bones:

1. Researchers and academics conduct studies in test tubes and on animals, sponsored by federal and philanthropic society research grants, pharmaceutical companies, companies that invest in new drugs or, less likely, contract research organizations. 
2. Researchers, academics and/or marketing executives present to the FDA their promising pre-clinical data in an application for IND (investigational new drug). This represents the culmination of many months of negotiations between the government and the sponsors.
3. Physicians, researchers and bureaucrats within the FDA (on the FDA committee) review the data and grant -- or deny -- IND status.
4. The new treatment is tested in humans in clinical trials conducted by academics and researchers following ethical guidelines. Some trials are managed by professional research organizations called contract research organizations (CROs). 
5. Researchers, academics and/or marketing executives submit to the FDA a new drug application (NDA) for a promising new treatment.
6. Advisory committees review the data and provide recommendations to the FDA. Scientific experts such as physician-researchers and statisticians serve as members and hear testimony from a wide variety of people, such as representatives of the public (patients; family members), insurance companies, marketing directors, politicians, non-clinical academics and lobbyists.
7. The FDA makes a final decision that may -- or may not -- follow the advice of the advisory committees.

Next: Determining "right" or "wrong."

Comments

[Jan Hasak]

It surely is a complicated process, isn't it? Thanks for enlightening your readers with this helpful information.
Jan

[Nadel]

It is a sensitive issue, because FDA is a very big government body and consider one of the reputable agency. Revoking FDA needs to talk and discuss in the congress.