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I think both points here have merit- on the one hand, loosening market restrictions on the drug companies is a bad idea, as the profit motive will surely outweigh any curative motive.
On the other hand, the previous poster is astute in pointing out that the current system actually favors the pharmaceutical companies by restricting public access to cheaper medicine under the guise of 'patient safety'. This was an infamous point in W's second presidential debate, when he said that we cannot allow US citizens to buy the exact same drugs cheaper from Canada, because he was concerned for their safety! (lol)
The irony is the Catch 22- of course the pharmaceutical industry lobbies millions of $ in order to control our drug legislation. But the safety threat is real when you're talking about buying drugs from unregulated markets, eg. China. Think about it- how do I know if I take heparin made in china that it doesn't have antifreeze in it? If you think I'm joking, check out the congressional hearings (C-span) on the FDA's regulation of Chinese drug imports- it's on the record that there is literally no oversight of a majority of manufacturing there.
So overall, I absolutely agree with the previous poster that we need to regulate the market to foster generic distribution, so patients who have to take medicine don't get ripped off by some billion-dollar-profit company. However, as the Dr points out, until we get the regulatory process in place, it may be more unsafe to take the heparin on the cheap.
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Dr. Quick Said:
And the added burden for the manufacturers is relatively minimal: new studies should incorporate cardiovascular endpoints and other safety measures, and for finished studies, a metanalysis of trial data should be done. Sure, this might take a bit of time and a bit of money, but it's not an undue burden.
It would be interesting to see just what we are talking about here. Is the extra burden of these additional analyses really the trivial matter that seems to be asserted in this piece, or does it, as the opponenet state, place a real obstacle on innovation. As long as nobody seems to be coming up with hard facts on either side it's difficult to judge just where the truth lies. If the regulators are just asking companies to jump through additional hoops that add expense and time unreasonably, then it's time they should be changed. But if procedures can be strengthened at minimal burden, why could anyone object?
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I agree that if the new rules do not stop innovation and guard people's health they are a good thing; however, the FDA has dragged its feet on some things that could benefit patients with diabetes. In particular, the establishing of rules so that generic insulin can be produced as well as making it difficult to reintroduce animal source insulins. Thes might provide lower cost treatments for both type 1 and type 2 patients. If, however, the new rules make it even more difficult and more expensive to introduce lower cost medications (i.e. generic insulin), then there is indeed something for the FDA to address. Many of the signers of this petition may be thinking of this sort of drug development rather than making it easier for pharmaceutical maufactures to produce drugs that might have undesireable cariac effects.