A Question Regarding Generic Prescription Drugs

I understand the life cycle of drugs. A new drug is introduced, which costs millions of $$ to develop. The manufacturer prices the drug as high as possible, in an effort to recover their investment. As time goes by, other firms license the drug, and so competition starts to erode the pricing. Later, when the original patents expire, “generic” drug houses start making the drug, and prices drop further.
Now, I see that many low cost generics are now made in places like India, eastern Europe, etc. If you buy such a drug, do you have any assurance that what you get is as good as the original drug? I understand that the FDA does some (limited) inspection and sample testing of imported generics, but in the end, are you basically taking the manufacturer’s word that the stuff is safe and effective?
Is there any reason to believe that an Indian-made generic isn’t as good as the American original?
I ask because it seems that places like Walmart now supplies generics, many of them imported. Are there sufficient checks/market forces to keep them honest?

I’m sure there’s exceptions (although I can’t think of any) but while a drug is under patent protection, other firms don’t license the drug in a way that creates competition. What does happen is that companies may license the rights in certain countries to other companies for a variety of reasons, or if they think the drug could use more marketing grunt than they can supply, they’ll enter into a co-promotional arrangement where two companies market the drug within a given country. But this doesn’t erode pricing.

The thing you might be thinking of in terms of licensing is that when a drug looses its patent, the original company may license the original molecule to a generic company, which saves the generic the need to develop its own copy.

I’ll leave it to experts in pharmacology to address the equivalence (or not) between brands and generics. There’ve been oodles of threads on this over the years if you want to dig into them.

Brand-name drugs are often manufactured overseas as well. The FDA has inspection authority and has banned some foreign manufacturers from the US market in recent years due to quality issues. 100% inspection is never going to be possible, though.

Caveat emptor.

I think it’s helpful to understand that a “drug” in the legal sense is often just a name and not a chemical compound.

There is a drug called “Arimedix” that has the chemical name of Anastrozole. They are one and the same. The difference is that AstraZeneca has paid for the required studies for safety and effectiveness to market that chemical as a drug for the treatment of a human disorder. They don’t “own” the chemical or the industrial process to make it, they simply control the rights to market it as a drug under the name of Arimedix.

Well, and before it came off patent, they had the right to bar anyone else from selling anastrozole in the US under any name.

Exactly. The name may be trademarked forever (or as long as the drug company cares to defend its trademark) but the patent on how to make the drug has a fixed lifespan. If you somehow develop a completely different way to make Viagra, you are free to make & sell the drug, as long as you call it something else, (Bonerall? Erectophil?)

Ornery and Diceman, what you’re saying flies in the face of what I’ve been lead to believe as someone peripherally involved in the pharma industry.

Diceman, isn’t the process you describe - developing a completely different way to make Viagra - exactly what the generic companies do? And they can’t sell their copies until they come off patent.

And Ornery - nitpick - it’s Arimidex.

Good fucking luck with that, if you get your drugs from a pharmacy controlled by your HMO and your HMO dictates where the drugs they sell you will be sourced from. You don’t get much choice.

My pills could be made in China for all I know and be full of who-knows-what toxic shit.