From 2005 to 2014, generic drugs saved the U.S. health care system 1.68 trillion dollars. Additionally, generics routinely cost 30 to 80 percent less than their brand-name counterparts. While generic drugs can clearly offer substantial cost savings to patients, the U.S. Food and Drug Administration (FDA) recognizes that some patients do not understand what a generic drug is and often resist accepting them in place of their brand-name counterparts.
To help physicians talk to their patients about the safety and effectiveness of generic drugs, the FDA has created a range of new and updated education materials including fact sheets, videos, an App and other resources which can be found on the FDA website.
FDA-approved generic drugs are required to meet rigorous FDA standards for safety, quality, and effectiveness. The standards are equally demanding whether the FDA is reviewing brand-name or generic drugs.
Physicians can find out if a generic version of a brand-name medication is available by using the FDA database [email protected], which includes a catalog of FDA-approved drugs. Physicians can also search the online version (or use the smartphone app) of the “Orange Book.” For very recent generic drug approvals, healthcare professionals can consult the “First Generics List” on the FDA website.
Information on the FDA website that physicians can use to talk to their patients includes:
- FDA-approved generic drugs listed in the FDA resource known as the Orange Book along with their brand-name counterparts for which they can be substituted.
- A generic drug has no significant differences from the brand-name drug.
- Any generic drug must provide the same therapeutic effect as the brand-name drug and must be just as safe.
- A generic drug must have the same active ingredient, strength, dosage form and route of administration as the brand-name product.
- Generic drug manufacturers must prove that their drug’s therapeutic effect and safety is the same as (bioequivalent to) the brand-name drug. In other words, tests must show the levels of the generic drug in the bloodstream are the same as the levels found when using the brand-name product.
- Approved generic drugs are generally only sold after patents and exclusivities protecting the brand-name version end.
With generics, “pharmaceutical equivalence” is the cornerstone of the FDA review and assessment prior to approval. This means that the active ingredient is identical to that of the brand name drug in exactly the same dose. Any inactive ingredients must be present for providing the same stability and delivery of the active ingredient to the bloodstream. The delivery of active ingredient is measured through “bioequivalence testing,” demonstrating that there is no difference between the rate and extent of absorption of the active ingredient for the generic compared to the brand-name drug. Minimal differences may be allowed, such as shape, scoring and storage requirement, and they may have only minor labeling (or package insert) differences.
Before generic drugs are marketed, the FDA’s Office of Generic Drugs (OGD) carefully reviews the critical elements of clinical performance found in the brand-name drug and ensures that changes in formulation and drug-release characteristics of the generic will preserve those critical elements in the context of the drug’s indication, target population, and duration of therapy. Generic drug approval is supported by solid scientific research, modern regulations, relevant clinical data, and assurance that manufacturing facilities comply with current good manufacturing practices4. Generic drug manufacturers must submit data to FDA about their manufacturing process that includes detailed information of how the generic drug will be made by synthesizing and combining the active and inactive ingredients. These data let the FDA know if the manufacturer can reliably make a high-quality product.
Following approval and marketing, generic drug products undergo continued post-marketing surveillance to detect any product quality issues and to investigate reports of potential therapeutic inequivalence. The FDA conducts rigorous reviews to make generic medicines meet high-quality standards, and conducts thousands of inspections of manufacturing plants each year to monitor drug safety.
With the information available from the FDA, physicians can confidently answer questions that help their patients understand that generics are as safe, effective and as high-quality as brand-name drugs ̶ with the added benefit of helping them save money.