Given the cynical political manipulation of the FDA’s decisions over the past few years, it is hard to greet this as a victory:
By a vote of 93 to 1, the Senate passed a bill this afternoon that gives the Food and Drug Administration sweeping new power to police drug safety, order changes in drug labels, and restrict the use and distribution of medicines found to pose serious risks to consumers.
The bill calls for a fundamental change in the philosophy and operations of the F.D.A., requiring the agency to focus on the entire life cycle of a drug — not just the years prior to its approval, but also the experience of patients who later take it.
Senators said the bill was a response to a widespread loss of confidence in the ability of the F.D.A. to protect consumers against the dangers of drugs like Vioxx, a popular painkiller withdrawn from the market in 2004. The bill would carry out many recommendations from the National Academy of Sciences and appears broadly acceptable to the House. The Bush administration has not actively opposed the measure and many drug manufacturers support it.
The bill is widely seen as “must pass” legislation because it renews authority for the government to collect fees from drug companies to speed the review of their products. Without action by Congress, the authority would expire Sept. 30.
The cardinal rule for me is that anytime a bill receives complete bipartisan support, it is universally a bad thing. The possibility for further politicization and mayhem appears to be overwhelming.
See also “Bankruptcy Reform”
The first thing the FDA will do with this new power is to stop all importation of drugs from Canada, Europe, etc. While I have heard allegations that some folks are receiving placebos or the wrong prescription from abroad, I feel fairly certain that protection will extend a bit beyond consumers, i.e. to the profit margins of drug companies.
Anyone got a reason for me to lighten up?
Agreed but at the same time with some of the side effects some of these drugs have had (ie death) the government should have a vested interest in monitoring these drugs because the drug companies won’t do it themselves.
So say we all.
See: The Patriot Act
Yeah, I always like to see a little diehard opposition from the other side of the aisle before I’m “for” a bill. Clearly a great many palms were greased to get this to run through so quickly.
Hell, I haven’t even heard about this legislation before today so it makes me super, double, extra suspicious.
While there is something to be said for being up front and welcoming regulation if you have nothing to hide there is something fishy if the Drug Co’s themselves welcome it…
The Other Steve
Not at all.
Regulation creates a barrier to entry for smaller competitors.
You can call this the Pfizer, Merck, Eli Lilly Marketplace Protection Act.
I like it. Call it the anti-Broder axiom.
In my neck of the woods we call this a “Bribe,” ‘tho older folks call it a “Recipe for Disaster.”
How’s that for cynical?
They do have some cheek, don’t they? It’s one thing for the government to take bribes. It’s quite another for them to be so bold-faced as to actually write it into legislation.
Now to add a bit more info from NPR, this ability has been around since 1992; basically Drug Companies could throw money at the FDA to hire more reviewers so that their drugs could get reviewed faster. This was an increase in the fees so that the FDA could track drugs after market.
Not so much paying money to get fast tracked, but paying extra money to get augmentees to review the drug.
I nominate the DMCA.
Figures these dummycrats still want to expand the powers of one of the goverments most out of touch depts
When the Senate is weighted 93 Democrats to 1 Republican, that will be a bad day for… well… how much is everyone – 93?
a BIRDZILLA post without CAPS and with only one misspelling?
what is the world coming to?
I’ve never understood what’s being alleged here. Are they saying that furriners are selling us placebos and keeping the good Lipitor for themselves? Because that would imply that either international pharmacies have more balls than brains or that American consumers are dumb enough to buy their maintenance meds at CrazyRaoulsDiscountDrugs.lu. Or do they actually think that there’s a difference between European and American Lunesta?
The reality is that most prescription medications are produced outside of the US (Puerto Rico and Ireland, for example, are both homes to multiple major US Pharmaceutical manufacturing plants) and the big difference between Dutch Lotrel and Kentucky Lotrel is the language on the insert.