the logo of the FDA
Few employees, many drugs and OTC products
It may seem like 2,889 employees[1] in the drug department of the FDA is sufficient to regulate all prescription drugs on the market.
But there are 17,143 drugs listed in the Orange Book, the FDA’s publication formally called Approved Drug Products with Therapeutic Equivalence Evaluations.[2]
The Orange Book has 16,609 drugs in the prescription category and 534 drugs in the over-the-counter (OTC) category.[3]
The FDA drug department supervises OTC drugs, like pain relievers and cold medicines. The website gives examples of other products it regulates that are not normally considered to be OTC drugs, such as fluoride toothpaste, antipersperspirants, dandruff shampoo and sunscreens. Think of all the differents brands of these over the counter products on the market they have to monitor.
The FDA drug department monitors a large amount of different products when OTC drugs are included in their jurisdiction.
Not only do the 2,889 employees perform drug evaluation and research on 17,143 drugs, they regulate marketing claims in all magazines, TV, pamphlets, physician seminars and luncheons sponsored by drug companies.
If a company claims a drug is effective for a condition it was not approved for, the drug company is in violation and receives a carefully detailed warning letter and follow-up from the FDA. It takes time to draft a legal warning letter and follow up letters to the thousands of companies that violate marketing laws and warning labels..
The FDA also monitors all drug-warning labels to ensure the right information is given to consumers. Consumers have a right to know if their medication has a risk for liver toxicity or gastrointestinal bleeding.
In summary:
Evaluation and research, regulating marketing claims, monitoring warning labels on all products and drugs, and taking legal actions...it's an overwhelming task!
Do we trust that only 2,889 employees in the FDA can protect us from the adverse reactions of 17,143 drugs?
[1]FDA www.fda.gov/AboutFDA/Transparency/Basics/ucm213161.htm
[2] FDA www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm Orange Book Preface 32nd Edition, FDA Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations
[3]FDA www.fda.gov/ohrms/dockets/ac/99/slides/3506s2/sld008.htm
It may seem like 2,889 employees[1] in the drug department of the FDA is sufficient to regulate all prescription drugs on the market.
But there are 17,143 drugs listed in the Orange Book, the FDA’s publication formally called Approved Drug Products with Therapeutic Equivalence Evaluations.[2]
The Orange Book has 16,609 drugs in the prescription category and 534 drugs in the over-the-counter (OTC) category.[3]
The FDA drug department supervises OTC drugs, like pain relievers and cold medicines. The website gives examples of other products it regulates that are not normally considered to be OTC drugs, such as fluoride toothpaste, antipersperspirants, dandruff shampoo and sunscreens. Think of all the differents brands of these over the counter products on the market they have to monitor.
The FDA drug department monitors a large amount of different products when OTC drugs are included in their jurisdiction.
Not only do the 2,889 employees perform drug evaluation and research on 17,143 drugs, they regulate marketing claims in all magazines, TV, pamphlets, physician seminars and luncheons sponsored by drug companies.
If a company claims a drug is effective for a condition it was not approved for, the drug company is in violation and receives a carefully detailed warning letter and follow-up from the FDA. It takes time to draft a legal warning letter and follow up letters to the thousands of companies that violate marketing laws and warning labels..
The FDA also monitors all drug-warning labels to ensure the right information is given to consumers. Consumers have a right to know if their medication has a risk for liver toxicity or gastrointestinal bleeding.
In summary:
Evaluation and research, regulating marketing claims, monitoring warning labels on all products and drugs, and taking legal actions...it's an overwhelming task!
Do we trust that only 2,889 employees in the FDA can protect us from the adverse reactions of 17,143 drugs?
[1]FDA www.fda.gov/AboutFDA/Transparency/Basics/ucm213161.htm
[2] FDA www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm Orange Book Preface 32nd Edition, FDA Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations
[3]FDA www.fda.gov/ohrms/dockets/ac/99/slides/3506s2/sld008.htm
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