Generic drugs law plans threaten makers

Financial Times News ^ | 2/14/07

[Maria S]

Generic drugs law plans threaten makers

Big pharmaceutical companies are facing a barrage of legislative proposals that could have a dramatic impact on the industry's future earnings power and open doors to one of its biggest threats: generic drug manufacturers.

A proposal set to be unveiled on Wednesday by Hillary Clinton, the Democratic presidential hopeful, and a bipartisan group of lawmakers would allow generic drugmakers to manufacture cheaper versions of biotechnology drugs produced by companies such as Amgen and Genentech.

[reformed_dem]

Boy, she's on a roll.

[stayathomemom]

Right. What else can these Socialists do to crush Michigan's economy?

[Vaquero]

its simple arithmatic.

if you tell the drug companies that the are not going to make a profit on their investment of research...then they wont do the research and the drugs wont be found to cure the diseases......

....the socialists who wish for new drugs will find themselves wanting.

[massgopguy]

When will she propose shutting down the Patent Office because from now on as Chip Monk said at Woodstock; "IT'S A FREE CONCERT!"?

[Bob Buchholz]

Wonder if she is in favor of dropping all copywrite laws.
How about if every publishing house could just copy a new book from another house and sell them for ten cents on the dollar the day after they were published? Think that may just do away with those 8 million dollar guarantees?

[LIConFem]

Wonderful. Let's kill innovation and strangle the biotech firms that cure diseases, while flooding the market with cheap knock-off drugs.

[KarlInOhio]

However, let's see how high she jumps when the RIAA tells her that college kids are stealing music. In the 'Rats eyes, the music industry must have every bit of revenue available to produce their latest "pop tart" (now that Britney is crashing). Drug companies don't need that protection for their new products.

[passionfruit]

The article is vague on the specifics of how this is supposed to work. I am actually interested in this for a very selfish reason. I am a migraine sufferer. I take Imitrex for the migraines and have for at least 15 years. I have been hoping for a generic equivalent to this drug. During the years I have taken this, I have had insurers refuse to fill it unless I jump through various hoops that they set up to make it as difficult and expensive and time consuming as possible.

I thought that the drug manufacturer had a monopoly for a certain number of years, and after that period, it could be manufactured as a generic drug. Unfortunately, the drug manufacturers will wait till the end, and make a tiny change to their drug to restart the clock on their monopoly.

Something should be done to ensure that the law works as it is intended, and let medications can go generic after a certain amount of time with their monopoly. The drug companies should have a monopoly for a certain amount of time to recoup their R&D, and to make a healthy profit, but after that period of time, let it go generic!

[Lou L]

I thought that the drug manufacturer had a monopoly for a certain number of years, and after that period, it could be manufactured as a generic drug. Unfortunately, the drug manufacturers will wait till the end, and make a tiny change to their drug to restart the clock on their monopoly.

While I'm sympathetic to your medical situation, I challenge the use of your word, "monopoly," in this example. A monopoly seems to be used in a derogatory way, as if the pharma company has manipulated the business environment in such a way that no other competitor can step in.

Aside from that, I'll answer your question. A patent does have a limited lifespan. In the case of pharmaceuticals, the patent may be extended when there are new treatment indications, or novel ways of applying the patented product. The reason for this is, a pharma company might find other uses for the drug through its R&D. Otherwise, it cannot get FDA approval to sell the drug for any other indication.

Having said that, once a pharmaceutical goes off patent, other generic companies may manufacture and sell that product (assuming FDA approval to do so). However, depending on the technolgy and costs associated with manufacturing, a generic may prefer to skip the more costly products; i.e., if it costs them a lot to make, they have to charge more, and be uncompetitive. You see this with a lot of the insulins, for example. It takes a long time in days, and uses expensive manufacturing techniques and equipment.

I hope you find a cheaper alternative. It sounds like a lot of good pharma R&D is working for you.

[Mack the knife]

While I'm sympathetic to your medical situation, I challenge the use of your word, "monopoly," in this example. A monopoly seems to be used in a derogatory way, as if the pharma company has manipulated the business environment in such a way that no other competitor can step in.

---

Actually, the word "monopoly" is the correct word to use. US Patent law grants an inventor a "monopoly" on the manufacture and sale of a patented product for a number of years in exchange for publishing the details of the technology. It is exactly a "state granted legal monopoly".

[Lou L]

Fair enough...thanks for clarifying.