I should say a little disclaimer here: I work in the pharmaceutical industry, but I was a libertarian type long before I did, so a lot of my opinions pre-date my involvement in the industry. I will also say that not all the FDA regs are stupid and overly burdensome. I think the government does have some roll to play in preventing drug companies from defrauding consumers.
Here’s one case I think they shouldn’t butt their noses into though:
The Food and Drug Administration will ask a panel of experts Tuesday and Wednesday whether it should require new contraceptive drugs to meet a standard of effectiveness before they are approved for the market.
No, this is not how to handle the problem. The FDA should ensure that the drug companies claims for efficacy are true, and that the information is provided to consumers. I think women are quite capable of weighing for themselves the efficacy vs. safety issue when deciding whether or not to take a particular contraceptive product. We don’t need government experts doing that for them!
I’ve long believed the FDA should be about making sure consumers know how safe an effective a certain drug is, rather than making choices for people. I’m totally OK with the FDA calling for more efficacy information being gathered on birth control, but don’t keep products off the market because a panel of government experts don’t think it’s efficacious enough. Let consumers decide that.
I agree with you in theory, but in practice…who buys the cheapest thing in the birth control aisle without stopping to read the effectiveness statistics/whatever? The stupid and/or poor. The former we definitely don’t want using ineffective birth control methods, and the latter…
I’ll just let that trail off right there.
oh, or teenagers, who usually fall into both categories.
I’m not generally in favor of protecting government from their own stupidity. Primary reason it is requires the government to treat everyone as stupid. Free societies operate on the principle that everyone is an individual capable of making choices. If someone chooses poorly, that’s their problem. I don’t really want it to become mine.
Wow.. I fucked that up… I’m generally no in favor of protecting PEOPLE from their own stupidity
Hey, Sebastian – ANY chance your company will be bringing Tibulone {sp?} to the U.S. market in the near future? We lived in Mexico for a couple of years, and my doc down there prescribed it {for those who don’t know, it’s a MUCH SAFER alternative to estrogen replacement therapy} – I KNOW ERT has a big following among the medical community here, but they’re pushing the wrong treatment for a lot of women ……………………. Tibulone doesn’t have the cancer/cardiovascular risks that ERT does ……………………. there ARE cases where ERT is the best choice, but for someone like myself who smokes, ERT is a non-starter …………………………..
Thanks for any info you can provide
Semper Fi’
DM
The company I work for isn’t in the ERT market, but the FDA rejected Tibolone for approval as an ERT drug in the US last June, so unless they approve it for another use, you won’t be able to get it in the US.
Here’s the company’s press release:
http://www.organon.com/news/press_releases/tibolone_not_approvable.asp
The FDA is corrupt. Look at all the money they spend on campaigns to rush things through. They own the presidency and most of the congress and senate WBR LeoP