Throughout the years, there has been a lot of controversy and confusion over the efficacy and safety of generic medications. Congress passed the Federal Food, Drug and Cosmetic Act in 1938. This act required the safety of all drugs (brand name and generic alternatives) through manufacturer testing and U.S. Food and Drug Administration (FDA) approval before they could be made available to the public. It came on the heels of an unfortunate incident in which a toxic medication released to the public caused more than 100 deaths.
Since the 1938 Act was passed, there have been numerous improvements made to the drug-regulation system and its guidelines. For example, generic medications must equal that of the brand name in form (pill, liquid, etc.) and dosage strength. In other words, a brand name medication, like Tylenol, is a pill containing 100 mg of the active ingredient acetaminophen, so the generic alternative must be the same.
What are the differences between generic and brand name medications?
The allowed differences include size, shape, color or markings. In fact, the FDA requires generic drugs to look different. Another, perhaps most controversial difference, are the inactive ingredients. Today, FDA-approved generic medications have different inactive ingredients than the brand-name version. Some health care providers have concerns about this, especially when it comes to narrow-therapeutic-index (NTI) branded and generic drugs like Warfarin, Levothyroxine, Carbamazepine, and Lithium Carbonate because they are safe and effective only within a small dosing range. NTI medications have very little difference between toxic and therapeutic doses.
What are the health concerns with switching between generic and brand name?
Most people can switch between generic and brand name medications (as well as different generic manufacturers) without noticing a difference in efficacy or safety. However, because of the sensitivity and potential dangers of NTI medications, the FDA is considering higher bioequivalence standards to ensure their generic and brand name versions are the same. These medications pose a high health risk if even a slight variation in the medication isn’t tolerated by the patient. As a result, doctors recommend using the same generic manufacturer to avoid slight variations in the medication. If the manufacturer must change for a particular reason, doctors will monitor their patient closely for adverse reactions that may be potentially life threatening or result in persistent or significant disability or impairment.
Are generic medications as effective as the brand name?
Yes. Generic alternatives are the same as brand name medications in dosage, quality, safety, the way it works, and the consumption method. According to research, lower-income patients often prefer brand name medications to generic because of a belief that they are higher quality. They believe that, because of their economic or social status, their doctor prescribed a generic medication.
Why are brand name medications more expensive than generic?
Brand name medications have a higher price point because manufacturers usually have to recover the cost of research and development, which ensures the safety and efficacy of the active ingredient. When the patent for a brand-name medication expires, generic medications can be made. However, they do not have to shoulder the financial burden of as much research and development. The consumer then benefits with less expensive medication. On average, the cost of generic medications is 80 to 85 percent lower than the brand-name version.
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