Typical government response to government failure ...
... more government, of course!
http://blog.nj.com/ledgerupdates/2007/05/senate_oks_plan_to_give_fda_mo.htmlThere's nothing not-bad in this pile of crap, which is no doubt why it passed so overwhelmingly in the Senate:
WASHINGTON - The Senate today approved wide-ranging legislation to strengthen the government's drug safety oversight. Adopted by a 93-1 vote, the Senate bill would expand the Food and Drug Administration's ability to monitor drugs for side effects, and to take quicker action to better protect the public if problems arise.
I wonder who the holdout was, but I don't really care enough to check - probably some loser who thought it wasn't socialist enough.
``This is breakthrough legislation,'' said Sen. Edward Kennedy (D-Mass.), the bill's sponsor. ``This legislation is going to make prescription drugs that our families take safer.'' 'Cause, you know, legislation IS what makes the sun come up in the morning. Idiot!!
The bill, which still must be approved by the House, follows a series of high profile cases in the past several years involving FDA-approved painkillers, antibiotics and antidepressants that turned out to have unexpected and in some instances deadly side effects. How to succeed in Government in one short lesson:
FAIL.
because, you know, if you actually succeed your budget (and power) won't increase. Absent the evil profit motive, there is NO REWARD for succeeding - but money and power galore for failing.
But let us move on:
A key provision of the bill would require the FDA to review the safety of some potentially risky medications at 18 months and at three years after approval, and to conduct active, routine surveillance of large public and private medical databases to better track possible harmful patient side effects of medications. Thus doing the job of the pharmaceutical companies at taxpayer expense.
The legislation also would empower the agency to require pharmaceutical companies to conduct postmarket studies of new medications, and set deadlines for revision of drug warning labels when problems occur. Here's the sort of 'regulation' that Big Pharma loves: the kind that cripples small, lean, innovative companies while giving their spinoff buddies juicy chunks of new make-work.
In addition, the Senate measure would greatly increase the user fees paid by the pharmaceutical industry for FDA review of new drugs, setting forth performance goals for speedy approval of the medicines. Drugmakers said this was a crucial element of the legislation for them.
Huh? The sane among us might wonder why Big Pharma would consider 'greatly increased user fees' 'crucial'. But see the previous paragraph. They LOVE this sort of thing. Another barrier to market entry! Yee-haa! Less competition!
The bill effectively blocks lower-priced drug imports from abroad - a key victory for drugmakers concerned that such a move could lead to an increase of counterfeit medicines and also undercut their profits. This is actually funny - except for the fact that it isn't. Oh. They are sooooo concerned about the safety of the sheep^H^H^H^Hpublic, and, err, incidentally, the safety of their profits. Please. Why don't you bozos worry about protecting your profits in the old-fashioned way (producing quality at a reasonable price) and let ME worry about 'counterfeit medicines'? Thanks but NO THANKS for that sort of 'protection', you thugs.
It imposes some added oversight on direct-to-consumer drug advertisements, but lawmakers deleted a provision this week that would have given the FDA discretion to ban some ads on potentially risky new drugs for up to two years. I'll bet. The BP lobbyists probably actually had to threaten to close the re-election purse-strings to get that thrown out (not that I think ads should be banned). How this could be seen as anything but a gang rape by Congress and its frat buddy Big Pharma is beyond me.