Are Brand Name Drugs Better Than Generics? Drugs are not Cornflakes

As most people know, when a drug is developed, the drug manufacturer receives a patent on that drug. The patent means no one else may produce that drug for a period of time. Drug patents in the US are 20 years, but these patents begin before clinical testing, so really, the drug manufacturer has about 7-12 years of patent protection once the drug is on the market.

After the patent expires, other companies may produce the drug, these are called generics.

Do you really need to pay the high price for brand name Prozac or is the generic, fluoxetine, just as good?

Brand Names are Better than Generics

Over the years, commenters have stated brand name drugs are “better.” I suspect this is just a common thought people have because they don’t like generic cornflakes as much as the brand name. But drugs are a bit different from corn flakes. There is no “Corn Flake Administration,” monitoring quality.

Drugs are Not Cornflakes

Generic drugs are not like that. Generics are controlled by the FDA just like brand name drugs. I can’t just stick something like the drug into a capsule and sell it. If I could do that, I’d be quite wealthy by now.

The active ingredients in a generic drug must be the same and act the same as the brand name drug. (And brand name drugs have to publish their chemical formula as part of the patent, so, you know, it’s not too hard to find.)

Generic Drugs are the Same as Brand Name Drugs

Of course, when I say, “the same,” what I’m really saying is they’re the same according to a scientific and legal definition. No one does a molecule-by-molecule comparison. That would be a bit tricky. And in fact, if you could do a molecule-by-molecule comparison, even different batches of the brand name drug would be different. Manufacturing is like that.

The way the FDA determines equivalency is a bit complex, but suffice it to say the active ingredient must be the same, it must dissolve the same way in the human body and it must produce the same results with the same dosage. This is called bioequivalence.

This is within a statistical margin, however. Bioequivalence of the generic drug is required to be 80% to 125% of the brand name drug.

Gah. That Sounds Terrible!

I know it sounds terrible, but understand, this is statistics we’re talking about. In practice the difference is more around 3%-4% (as shown in a review of 2070 studies). This is about the same as the variance possible from different batches of the same brand name drug.

The Caveat

The one thing to realize is while the drugs are the “same” and the active ingredients are thoroughly tested, inactive ingredients may differ. These agents, like binding agents, have no active effect but nevertheless may change how an individual responds to a specific medication. Understand, this is vastly the exception and not the rule.

Occasionally a generic drug will be suspected of being less effective than the brand name (due to patient and doctor reporting) and the FDA will investigate. The Administration of Corn Flakes has your back on this.

While I, personally, have no trouble taking generic drugs and no trouble saying they are the same, there is no accounting for individual chemistry.

So Generics are the Same as the Brand Name Drug

Yes, in my opinion (and in the FDA’s) generic drugs have the same effect as brand name drugs. It’s simply another case in life where paying more (say, five-ten times more) does not mean you’re getting a better product, it just means you’re getting better marketing.

You can find Natasha Tracy on Facebook or @Natasha_Tracy on Twitter.

Laser-branded cornflake (seriously) picture from Ad Age Global.