sticker shock

[cellio]

Good heavens. I had not realized that list price for my allergy medicine is almost $3/day. (My co-pay, fortunately, is 50 cents/day.) C'mon, guys; develop generics! Besides, it would lower my co-pay a bit. :-)

Fortunately, I do not take allergy drugs year-round -- just for about 6 weeks in the summer, starting soon. I have mild allergy symptoms for longer, but I tend to develop immunities to allergy drugs after a while, and I'd rather not do that again.

Comments

I'm sorry, but you are wrong.

[sethcohen.livejournal.com]

It is not up to the generic company as to when a generic hits the market in the United States. It is a matter of FDA approval and patent law.

In the US, drug companies have 20 years on their patents from the date of first discovery. That is, when they declare that they are researching a novel molecular compound, that's when the clock starts ticking. Depending on the drug and how long it takes to make it through the clinical testing and clinical review process, a drug company may only have a few years to market and sell their product before their patent runs out. This is important, as the cost of developing a new drug product in the US is above one hundred million dollars. Yes, I typed that correctly. $100,000,000.00 and up.

The drug molecule is readily available. The drug (as opposed to the delivery system - you know, the thing you swallow) is not usually manufactured by the company whose name is stamped on the tablet. When the patent runs out, all the generic manufacturer has to do is to acquire some of the drug, and put it into a compatible delivery system that matches the dissolution, absorption, and elimination of the brand product. Until that patent runs out, it is illegal to market a generic equivalent for a brand product. Usually, the generic company has already tested their product and has it ready to ship the instant the patent has expired...but they can't ship it before then. It's against the law.

That's how it works. Any questions?

Re: I'm sorry, but you are wrong.

[cellio]

Thanks for the information! I didn't realize that's how it works, or that development was anywhere near that expensive. I wonder how that figure breaks down among actual development, testing, paperwork, and marketing. I hope that testing is the largest part of that, but I fear it might be paperwork.

(It was also a generic, frustrated "guys", not a particular target.)

Re: I'm sorry, but you are wrong.

[sethcohen.livejournal.com]

Part of what has pushed the cost of drug development up in the last decade in the US has been the advent of direct-to-consumer marketing.

The most time-consuming part is the paperwork, but I guess if you define paperwork differently than I do, you might get a different answer. I can't tell you much about the actual numbers for any given drug...any way you slice it, it's not cheap.

Also, getting a generic to market is a lot less expensive than getting a novel compound to market, obviously.

costs

[cellio]

Part of what has pushed the cost of drug development up in the last decade in the US has been the advent of direct-to-consumer marketing.

Good point. I hadn't been paying attention to that, as I watch little TV and that's where (I gather) the ads are most prevelant. Well, that and my inbox, but I would be delighted if I would stop receiving spam for Viagra. :-)

My mind still boggles at the costs. In particular, it boggles at the notion that this is worth it for the drug companies -- that they make enough in those few years when they own the market to make up for hundreds of millions of dollars of R&D. Industries of that magnitude are just a bit outside my area of experience. :-) I'm sure drugs aren't the only area where it plays out like this; I'd imagine that things like aircraft are similar in scope. But still... wow.

Re: costs

[sethcohen.livejournal.com]

You will never stop receiving spam for Viagra. You might as well ask for the moon on a silver platter. So is life.

The next industry where you see things like this is probably the auto industry, not the aircraft manufacturing industry. Airplane design is much more static than automobiles, and car sales are based more on advertising than actual differences between products. Granted, the cost to get a vehicle to market is less than the cost of getting a drug to market, but I'll bet that the advertising costs are not far off. Next, you should consider Hollywood and their costs and marketing. We could go on and on, but I'm sure everyone has the picture now.

Re: Claritin and generics

[lefkowitzga.livejournal.com]

The case with Claritin is unusual in that it is the first case of a "citizen's petition" rather than the manufacturer requesting the FDA panel review the drug for generic release. The 'citizen' in question was an insurance company that didn't want to pay for prescription Claritin, Allegra, and Zyrtec allergy medications due to the high demand. Here is an interesting article on the topic: http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&node=&contentId=A48521-2002Nov27¬Found=true