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The Health Pages > General Health > Generic Drugs
Generic Drugs
Generic products get a bad rap in a lot of industries; they’re ridiculed for being no-frills and low-quality. That may be the case in some industries, but there is at least one industry where you can expect your generic product to be equivalent to the brand name, every time: pharmaceutical drugs. In fact, few agencies impose such high standards of quality on generic products the way the Food and Drug Administration (FDA) does.
Price
When push comes to shove, there aren’t too many products in your life that you rely on for your health and well-being like medications. When you need them but can not afford them it sets up a difficult situation—unless the medication is available in generic form. Too few people realize that generic alternatives—sometimes costing as low as twenty percent of the brand-name’s cost--may be available.
It may surprise some readers to learn that products such as medications can contain precisely the same ingredients yet have such a disparity in cost. Keep in mind that by the time the generic version of a medication hits the market, the brand name version has been the exclusive seller of that product for many years.
The manufacturer, in this case a pharmaceutical company, spent millions of dollars developing the drug, running clinical trials, marketing, branding, etc, so the law allows for them to try and recoup some of that on the market once the FDA approves it, before the generic can be released to undercut it. In short, generics are so much more inexpensive because the drug companies making them did not have to invest millions in the development of the product.
In a similar sense, you the patient also benefit in this arrangement—at least once the patent has expired and generics are allowed onto the market. You can also rely on generics: According to Stuart L. Nightingale, M.D., FDA Associate Commissioner for Health Affairs, "In approving a generic drug product, the FDA requires many rigorous tests and procedures to assure that the generic drug is interchangeable with the brand-name drug under all approved indications and conditions for use.
Consequently, in order for the FDA to approve a generic version of a brand-name drug, the generic is required to be:
• Pharmaceutically equivalent, meaning it must have the same active ingredients as well as dosage form (tablet, capsule, liquid), strength, and administration route (IV, oral) as the brand-name drug it mimics.
• Bioequivalent, meaning the generic has to act upon the body in the same manner and degree as the brand-name drug it mimics. A typical gauge is how gamely the generic enters the bloodstream to become available to the body.
• Approved as safe and effective, meaning the generic drug needs to prove itself to be a copy of the original, FDA-approved drug.
• Manufactured in compliance with Current Good Manufacturing Practice regulations, meaning every pharmaceutical company has to meet the same FDA inspection and efficacy standards, whether they make brands or generics. For instance, the FDA reviews a pharmaceutical company’s processes of manufacturing and sterilization, raw material specifications and controls.
• Adequately labeled, meaning the patient information included with both the generic and the brand-name medication must be largely identical to one another.
However, the FDA indicates that a therapeutically equivalent generic may differ from its brand-name twin in certain minor characteristics, such as size/shape, mechanisms of release, packaging and other variables (like color or flavors), expiration date/time and minor aspects of labeling. In the event these minor differences prove to be relevant in patient care, a doctor has the ability to specifically prescribe the brand-name drug, but this is not common.
In conclusion, if you are taking prescribed medications and paying an arm and a leg for them, ask your doctor or pharmacist if there is a generic form of those medications available. There’s no reason to be paying hundreds of dollars for your monthly medication when an equivalent generic alternative is available.
Generic Drugs
Generic products get a bad rap in a lot of industries; they’re ridiculed for being no-frills and low-quality. That may be the case in some industries, but there is at least one industry where you can expect your generic product to be equivalent to the brand name, every time: pharmaceutical drugs. In fact, few agencies impose such high standards of quality on generic products the way the Food and Drug Administration (FDA) does.
Price
When push comes to shove, there aren’t too many products in your life that you rely on for your health and well-being like medications. When you need them but can not afford them it sets up a difficult situation—unless the medication is available in generic form. Too few people realize that generic alternatives—sometimes costing as low as twenty percent of the brand-name’s cost--may be available.
It may surprise some readers to learn that products such as medications can contain precisely the same ingredients yet have such a disparity in cost. Keep in mind that by the time the generic version of a medication hits the market, the brand name version has been the exclusive seller of that product for many years.
The manufacturer, in this case a pharmaceutical company, spent millions of dollars developing the drug, running clinical trials, marketing, branding, etc, so the law allows for them to try and recoup some of that on the market once the FDA approves it, before the generic can be released to undercut it. In short, generics are so much more inexpensive because the drug companies making them did not have to invest millions in the development of the product.
In a similar sense, you the patient also benefit in this arrangement—at least once the patent has expired and generics are allowed onto the market. You can also rely on generics: According to Stuart L. Nightingale, M.D., FDA Associate Commissioner for Health Affairs, "In approving a generic drug product, the FDA requires many rigorous tests and procedures to assure that the generic drug is interchangeable with the brand-name drug under all approved indications and conditions for use.
Consequently, in order for the FDA to approve a generic version of a brand-name drug, the generic is required to be:
• Pharmaceutically equivalent, meaning it must have the same active ingredients as well as dosage form (tablet, capsule, liquid), strength, and administration route (IV, oral) as the brand-name drug it mimics.
• Bioequivalent, meaning the generic has to act upon the body in the same manner and degree as the brand-name drug it mimics. A typical gauge is how gamely the generic enters the bloodstream to become available to the body.
• Approved as safe and effective, meaning the generic drug needs to prove itself to be a copy of the original, FDA-approved drug.
• Manufactured in compliance with Current Good Manufacturing Practice regulations, meaning every pharmaceutical company has to meet the same FDA inspection and efficacy standards, whether they make brands or generics. For instance, the FDA reviews a pharmaceutical company’s processes of manufacturing and sterilization, raw material specifications and controls.
• Adequately labeled, meaning the patient information included with both the generic and the brand-name medication must be largely identical to one another.
However, the FDA indicates that a therapeutically equivalent generic may differ from its brand-name twin in certain minor characteristics, such as size/shape, mechanisms of release, packaging and other variables (like color or flavors), expiration date/time and minor aspects of labeling. In the event these minor differences prove to be relevant in patient care, a doctor has the ability to specifically prescribe the brand-name drug, but this is not common.
In conclusion, if you are taking prescribed medications and paying an arm and a leg for them, ask your doctor or pharmacist if there is a generic form of those medications available. There’s no reason to be paying hundreds of dollars for your monthly medication when an equivalent generic alternative is available.
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