What is a GENERIC Drug?

A recent Twitter post by @PenguinCrystal in response to a blog post of mine stated "Generics aren't always equal," and that as a pharmacist, I should know that. See the original blog post HERE.

Basically my blog post recalls the story of a lady who brought back medication because it said "Endocet" on the label instead of "Oxycodone." The IRONY is that Endocet IS Oxycodone. Further irony occurs because in a lot of areas, the locals PREFER Endocet over the other generics. Finally, even more irony happens when I find out the patient is on Medicaid. Now I can't speak for all Medicaid patients, but the majority of mine are not overflowing in the IQ department, hence the blog post to begin with.

But as the tweet by @PenguinCrystal shows, there is a plethora of uneducated folks out there with a complete misunderstanding of generic medications. So just what is a generic medication? Below I have copied and pasted from the FDA website:

Generic Drugs: Questions and Answers

What are generic drugs?


A generic drug is identical -- or bioequivalent -- to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

Are generic drugs as effective as brand-name drugs?

Yes. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used.

FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.

Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.


Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.

What standards do generic drugs have to meet?

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

> Contain the same active ingredients as the innovator drug(inactive ingredients may vary)
> Be identical in strength, dosage form, and route of administration
> Have the same use indications
> be bioequivalent
> Meet the same batch requirements for identity, strength, purity, and quality

> Be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

Discussion

Are there some generics out there that are not bioidentical to the name brand? Possibly. If this happens it usually shows up pretty quickly and is usually a manufacturing issue of some kind. Any time there is a question about any drug in the marketplace there is an immediate recall. But the vast majority of generic medications meet or exceed the standards of the brand/trade name.

Do companies actively make less potent medications to cut costs? In the United States or most first world countries, no. But if you're buying a generic from some shady mail order company or an Internet pharmacy based in India? Watch out. That's a different circus and a different monkey.

Millions upon millions of drugs are dispensed every day in thousands of pharmacies. The vast majority of medications have generics made by a multitude of companies. Suppose they really were all in collusion with each other to make less potent medications... the sheer manpower alone to create and maintain such a widespread conspiracy to cover up everything would cost more than the "profit" made from such a conspiracy.

Further suppose generic medications really don't meet the same equivalency as their brand/trade counterparts... then where is the outcry from the brand companies? Why isn't Lipitor suing the generic manufacturers? Or more likely, why aren't they running ads on TV stating "all generics of Lipitor are not equivalent"? The reason WHY you don't see these ads is because they don't have a legal leg to stand on.

So in conclusion, if you're a patient, feel safe using your generic medication and enjoy the money you saved. Yes, it's that simple.