Medicine / Brand-Name Drugs, Generic Drugs, And Illegal Prescription Drugs If you've thought about buying prescription drugs on the internet you may have found the whole experience rather confusing.
-- Are generic drugs as good as brand-names?
-- Are drug copies such as "generic viagra" safe to use?
-- Does it matter if a drug is not "FDA approved"?
-- Are you breaking US laws if you buy non-FDA-approved drugs on the internet?
These are just some of the questions many people have about online pharmacies and online drugs. The purpose of this article is to answer some of these questions
1. What is a Generic Drug?
In the US and many other countries, a "generic" drug is a copy of a brand-name drug. It has identical active ingredients as the brand-name version, and so it is the same as the brand-name version in dosage, safety, strength, quality, performance, and intended use.
A generic version of a brand-name drug is not just similar to its brand-name counterpart. It is identical in all its important characteristics. It must not look like the brand-name version, and it may have a different flavor. But the amount of important active ingredients is the same, and therefore it has the same therapeutic characteristics as its brand-name counterpart.
2. Does every Brand-Name Drug have a Generic Counterpart?
No, every brand-name drug does not have a generic counterpart. This is especially the case with newer drugs such as Viagra, Cialis, and Levitra. These brand-name formulations are patent-protected for 20 years from the date of the submission of the patent. That means that no other drug company can introduce a "generic" version of any of these drugs while its patent is in effect. This allows the original developer of the brand-name drug to recover research and development costs.
When the patent for a specific drug expires, other companies -- including the original developer of the brand-name drug -- can apply to the FDA to sell generic versions.
This also explains why legitimate generic drugs are cheaper than their brand-name counterparts. A generic manufacturer does not have to recover research and development costs and can therefore sell them for less. This also has a tendency to drive down the price of the brand-name version as well.
3. Do Generic Drugs have to be FDA-Approved?
Yes, all prescription drugs, including all generic drugs must be FDA approved. In order to be sold to the public, generic drugs must pass the same FDA inspections as their brand-name counterparts. They must be manufactured to the same high standards, and the facilities where they are produced are subjected to the same inspections. In fact, an estimated 50 percent of all generic drugs are produced by the same company that produces the brand-name version of the drug.
4. Is there such a thing as a Non-FDA-Approved Generic Drug?
No, technically speaking, there is no such thing as a non-FDA-approved "generic drug." As outlined above, legitimate "generic" drugs must have the same characteristics as their brand-name counterparts, and must pass through the same FDA approval process in order to be sold to the public.
When an offshore company copies a brand-name drug before its patent expires it cannot get an FDA approval because it is breaking US law.
5. Problems with Offshore Copies of Brand-Name Drugs
There are two major problems with so-called "generic" drugs that are not FDA approved.
-- It is illegal to sell these drugs in the US (and other countries) because buyers and sellers are ignoring US and international patent laws
-- It is dangerous to buy and use these drugs, because they are not subject to inspection and regulation. According to some sources, "many of these generics are created in unsanitary, make-shift labs and over half of these medications tested are cited for being unsafe for consumption." In many cases they are found to contain "little to none or too much of the active ingredient."
6. How Can You Be Sure You are Buying FDA Approved Drugs?
-- The website should say "FDA Approved" or "FDA Approved Pharmaceuticals"
-- Websites offering "generic" versions of newer drugs such as Viagra, Cialis, Levitra, and Propecia are selling non-FDA-approved versions of these drugs. These drugs have not been around long enough for their patent to have expired, so the "generic" copies are illegal copies.
-- Never buy from a website that has no phone number to call or physical address you can verify.
-- The online pharmacy should have knowledgeable licensed consultants able to answer your questions. |
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