Generic Drugs
The FDA ensures generic drugs are as safe and effective as their brand name counterparts. That means patients can realize significant savings on medications, without sacrificing quality and safety.
What is a generic drug?
Generic drugs are the un-branded form of a prescription medication.
How does the FDA review generic drugs?
The FDA puts all generic drugs through a rigorous, multi-step process to ensure generic drugs when compared to their brand name counterparts:
- Are the therapeutic equivalent
- Produce the same clinical effect
- Meet the same safety profile
- Have the same active ingredients and same amount of active ingredients
- Deliver active ingredients in the same amount of time
- Are available in the same strength and dosage form
- Are shown to work the same in the body
- Perform in the same manner
- Have the same risks and benefits
- Pass a review of both active and inactive ingredients
- Include the same information found on the packaging of its label
- Have its manufacturing facility pass rigorous inspection
- Be continuously monitored for quality control, even after it’s been approved
Why do generic drugs cost less?
Generic drugs cost less because their manufacturers don’t have to invest hundreds of millions of dollars to complete research and development on the original drug. The brand name drug manufacturer makes that investment, along with the millions of dollars needed to market and advertise the new drug. Therefore, it costs the generic manufacturer less to develop the same drug—and those savings are passed on to patients.
How much can I save with generic drugs?
Research shows that using generic drugs can save between 30 to 80 percent over brand name drugs. But the exact number depends on the specific prescription drug coverage.
Source: fda.gov