This post was written by Haley Michaud, PharmD, Parkview Health.
When choosing medications, patients typically encounter brand-name and generic drugs. While both types are designed to treat medical conditions effectively, understanding their subtle differences can help you make more informed decisions regarding your health. Below, we cover the approval process for these medications and discuss how this impacts your treatment options.
FDA drug development process
The Food and Drug Administration (FDA) protects public health by ensuring that all drugs, biological products and medical devices available in the U.S. are safe and effective. Before a new medication hits the market, drug manufacturers must submit applications to the FDA for review and approval. This process is rigorous and involves multiple steps, including:
Discovery and development
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The first step begins with research to identify a potential new drug.
Preclinical research
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Laboratory and animal testing is conducted to determine if the medication has the potential to cause serious harm.
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After successful testing, an Investigational New Drug (IND) application is submitted.
Clinical research
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Studies and trials are conducted in humans to determine the drug's safety and how it interacts with the human body.
FDA review
The manufacturer submits a New Drug Application (NDA), and the FDA reviews the data to decide whether to approve or deny the drug. If the medication is approved, the FDA performs post-market safety monitoring, which involves:
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Overseeing cases of adverse reactions through FDA MedWatch.
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Conducting routine inspections of drug manufacturing facilities.
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Regulating medication advertisements and labeling to ensure that they do not promote unapproved uses of the products.
Brand-name
Brand-name drugs are the original medications developed and researched to treat a specific condition. They are also known as "innovator" or "originator" drugs. These pharmaceuticals are protected by patents that prevent manufacturers from selling or making them for a specified period, typically a decade or more.
The patent provides the company with exclusivity in marketing the medication at its own price, helping it recover some of the expenses involved in researching, developing and marketing the drug.
Oftentimes, patients will recognize the brand name for medications due to the amount of marketing in advertisements.
Examples: Eliquis® or Xarelto® for blood clots, Lipitor® for cholesterol
Generic
Once the patent on a brand-name drug expires, generic drugs can enter the market. Although generic manufacturers must still obtain FDA approval, their process is typically shorter. This is called the Abbreviated New Drug Application (ANDA) and does not require manufacturers to include new animal and human studies data.
The FDA requires drug companies to prove that generic medications can be effectively substituted to provide the same clinical benefit as brand-name medications. During the approval process, they must demonstrate the following qualities to remain equal:
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Active ingredient
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Strength
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Dosage form
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Route of administration
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Manufacturing standards
Examples: acetaminophen (Tylenol®) for pain relief, lisinopril (Zestril®) for blood pressure, atorvastatin (Lipitor®) for cholesterol
What are the main differences between the two?
One of the first noticeable distinctions between originator and generic drugs is their name. Generic medications are typically named after the drug's active ingredient instead of the manufacturer's brand.
The cost and appearance of the medication are also key differentiators. Generic medications are typically 80-85% less expensive than the brand-name version, primarily because they undergo fewer development processes. Although the drugs have the same active ingredients, they do not have to include the same inactive ingredients. This means the medication can appear different in color, shape or size.
Which is better?
While these drugs may not differ at a chemical level, one may be more suitable in some instances. Brand-name medications may be preferred if a patient is allergic to an inactive ingredient found in a generic version or if a healthcare provider believes the slight difference in formulation can significantly impact treatment outcomes. In contrast, generic versions are often chosen for their cost-effectiveness when available. Research has shown the affordability of generic drugs to promote increased access and long-term medication adherence.
If you have questions about your generic or brand-name medication options, Parkview Outpatient Pharmacies is here to help. We are committed to exceptional service and work directly with your doctor to ensure medication appropriateness and safety. Contact your preferred Parkview outpatient pharmacy, and our staff will gladly assist you with questions or prescription transfers.
Resources:
FDA: The Drug Development Process
FDA: Inactive Ingredients in Approved Drug Products
