Posted by Adam on February 16, 2000, at 17:27:14
In reply to Re: FDA-Rebox. doesn't look too promising, posted by Leighwit on February 16, 2000, at 15:15:11
From what I've heard through my job, the FDA isn't really influenced by anyone from the outside as far as their decision-making goes, unless compelled to do so by new laws. I'm not sure that writing to your congressman/woman would make any difference one way or another for the particular case of reboxetine. Besides, what does your average legislator know about drugs (or mental illness, or much else, for that matter)?At an internal R&D meeting my employer holds every year, a VP gave a long talk about the arduous journey of a particular drug through the regulatory process, a drug that took an especially heroic effort to get approved. The FDA kept asking over and over for more information, rewrites, more experiments, etc. Some regulators would literally zero in on real or percieved problems with grammar or semantics in the mounds of submitted paperwork that would set the process back weeks. It took three major attempts before the drug was finally approved, and my employer still isn't certain how long it will require to recover the money spent to get it out the door. It's close to a zero-sums game at this juncture, even though the drug has been proven to be quite useful.
At one point the VP put up a slide of Fred Astaire. He stayed silent for a few seconds, and then said "Once you done all that it is possible to do, perhaps then it's time to try a little song and dance. I was tempted."
The FDA does a good job of keeping us from being poisoned. However, I have the distinct feeling that it is widely populated by litigious nitpickers who are more concerned that you dot all your i's and cross all your t's than about real issues of safety or benefit. It also seems this branch of the government is beholden to none unless something dangerous is approved. Given near zero consequences for denying safe and effective drugs (one can always find something wrong), and dire consequences for approving unsafe and/or ineffective ones, there is an obvious preference for hypervigilance these days, and a desire to cover one's own ass when the time comes to give the green light or the red.
You can try to suggest legislation to change the way the FDA operates. Even better, one can try to enact legislation that puts realistic limits on liability. Safety and efficacy are only one part of the equation in the USA. It's a battle of the lawyers as much as anything. Why should one have to spend $200 million+ to get a drug approved unless the threat of a class-action lawsuit is even more expensive?
> I'm in the US and taking reboxetine through my Pdoc who orders it from a pharmacy in London. I consulted with a psychopharmacologist also before starting this drug.
>
> Drugs (at least those from the UK) without FDA involvement, have minimal labeling. You would not believe how vague the package insert is. Someone in the UK on reboxetine commented on another ng about how sophomoric the labeling information is on all of their drugs. "Pathetic" was the term I believe he used.
>
> I'm not defending the slow approval process by any means. But I do have a new appreciation for the information the FDA requires the pharmaceutical companies to provide to the public.
>
> I have juvenile-onset (Type I) insulin-dependent diabetes. The contraindications for ADs matter a great deal to all of us; particularly those with chronic medical conditions.
>
> If I lived in the UK, I'd be researching FDA information to make safe choices.
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> Just some thoughts about the flip side of the coin.
>
> LW
poster:Adam
thread:21540
URL: http://www.dr-bob.org/babble/20000209/msgs/21839.html