Healthcare Education Campaign: What FDA-approval Means to the Consumer
As consumers, we are constantly warned against using drugs that are not FDA-approved. Recent seizure of a non-FDA approved drug marketed by Jan Marini Skin Research, Inc. as an eyelash lengthener and controversy surrounding a non-FDA approved fat removal treatment, lipodissolve, has prompted eHealthinfoline.com to explain what it means when a drug is FDA approved.
1) What is the Food and Drug Administration (FDA)?
The FDA is an agency of the US Department of Health and Human Services that regulates the development, approval, manufacture, sale and use of drugs in the United States. Their mission is to promote and protect the public health by ensuring that safe and effective products reach the market and are labeled truthfully. They also monitor products for continued safety after they are in use.
2) How long does the FDA-approval process for a drug take?
Drugs are subject to rigorous laboratory, animal, and human clinical testing prior to FDA approval. These tests can take more than 5 years and cost an estimated $100-200M per product.
3) How can I be sure that a drug is safe for human exposure?
FDA-approved drugs have gone through extensive pre-clinical tests in animals prior to any exposure in humans. Some examples of pre-clinical research performed on FDA-approved drugs:
- Safety Pharmacology: To study the drug’s impact on cardiovascular, respiratory, and central nervous systems
- Pharmacokinetics: To study the absorption, distribution, metabolism, and elimination of the drug.
- Reproductive Toxicology: To study the effect the drug has on female and male reproductive function, fetal, and post-natal development
- Genotoxicology and Carcinogenicity: To study mutagenic or carcinogenic properties the drug may elicit.
- Single and repeat dose toxicity: To determine the safety and maximum tolerated dose.
Promising new agents that undergo pre-clinical testing in animals can be designated by the FDA as an Investigational New Drug (IND) if the pre-clinical data is positive and FDA requirements are met.
4) How can I be sure that a drug has a proven safe and effective dose and regimen?
FDA-approved drugs have gone through extensive clinical testing in humans to ensure that the drug is safe and effective. There are 3 clinical trial phases:
- Phase I: Is it safe? Healthy study participants are exposed to the drug and any adverse events are documented. Tests are performed to determine absorption, distribution, metabolism, and elimination of the drug. Immunogenicity tests to determine allergy potential are performed.
- Phase II: Is it effective? This phase determines if a drug’s activity may be beneficial against a particular disease or condition. FDA-approved rating scales specific to a condition or disease are used to record data.
- Phase III: This phase serves as confirmatory efficacy and safety and the study population is much larger. The results from these studies are sometimes published in peer-reviewed journals.
After all clinical testing is undertaken, the FDA determines if the data is enough to establish the safety and efficacy of the new drug for a particular indication. A new drug application (NDA) is filed after completion of human clinical trials.
5) How can I be sure that the materials of a drug are pure?
FDA-approved drugs are subject to manufacturing regulations to known as Current Good Manufacturing Practice (cGMP). This requires manufacturers of the drug to take a quality approach in order to minimize instances of contamination, mix-ups and error. This protects the consumer from purchasing an ineffective or adulterated product and ensures that the product is of high purity.
6) How can I be sure that the marketing claims made by a drug company are supported?
Marketing claims for an FDA-approved drug must be within FDA-approved labeling to ensure that those claims are supported by clinical data.
7) How can I be sure that a drug is being continuously monitored post-FDA approval?
By law, FDA-approved drugs require ongoing monitoring. Any reports of adverse events are subject to strict FDA reporting requirements.