Here's another disappointment that isn't totally surprising: there was an amendment under vote in the Senate yesterday on whether to allow cheaper foreign drug imports to the market to keep US drug pricing more honest. But the measure failed 48-51. Sponsored by Sen. Dorgan, he estimates that the provision would save $10B and also includes some rigorous safeguards. A similar measure is already in the House health bill that passed. As you would expect, the Senators who voted nay to block cheaper imports received on average 70% more funding from pharma-related sources than the yay votes (see list in first link at the end). But maybe the vote is a moot point anyway, since the Obama administration already cut a boneheaded deal with PhRMA that I previously emailed about (http://worldaffairs-manwnoname.blogspot.com/2009/08/health-care-overhaul.html), and the Dorgan amendment would violate that agreement.
I know there are safety and quality issues associated with drugs from any origin, but we currently allow imported food, vehicles, toys, building materials, and such - all of which can and have sickened and killed Americans. European laws enabled drugs to cross their borders to different markets for the last 20 years, and their safety record is no worse than ours. Even according to Pfizer's (biggest pharma in the world after merging with Wyeth) former marketing VP Dr. Peter Rost, drugs that are made at the same plant and have the exact same safety profile are sold in the US for prices up to 10X higher. Why? He was fired from Pfizer soon after he made these claims on "60 Minutes". I find this issue ironic because those "socialist Europeans and Canadians" actually maintain a mostly free market for drugs and private insurance, while capitalistic, laissez-faire America practices protectionism and monopoly. And then they play the "safety" card any time their profits are challenged.
Safety huh? Foreign-made stuff is always worse than American (tell that to Detroit). Let's not forget that some "American" drugs are already manufactured overseas for cost savings and tax evasion (but still are FDA-approved as if the plants were on US soil). Pfizer alone has plants in Belgium, France, Germany, Ireland, Japan, and Puerto Rico. In fact they may not have any US manufacturing, or due to the Wyeth merger it will be heavily downsized. Plus plenty of American-made and FDA-inspected drugs have hurt people too (Vioxx, Yaz, Celebrex, heparin, and most recently a recall of H1N1 youth vaccine that isn't toxic but sub-potent).
If the laws are written intelligently and regulators and manufacturers cooperate on due dilligence, then threats to public health should be minimal, or at least not much worse than at present. 6% of the world's people live in North America, yet our region accounted for 43% of global drug sales in 2007. And I don't think most of those drugs went to people in Chiapas or Winnipeg. We are the drug maker's cash cow, so obviously they will do everything they can to preserve the status quo.
http://maplight.org/dems_senate_pharma_prescription_drugs
http://www.seniormag.com/canadianpharmacy/articles/safe-medications.htm
http://www.tmcnet.com/usubmit/2009/11/13/4479586.htm
http://www.cbsnews.com/stories/2005/06/03/60minutes/main699606_page3.shtml
http://www.drugrecalls.com/
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Unfortunately, this is all about what you describe as 'the boneheaded deal with PhRMA.' For some reason, and maybe he was right, Obama felt he had to cut the deal (caveat: I don't think this has ever been officially admitted to) in order to get national health care reform. The deal was apparently intended to get PhRMA on the side of "reform" and not use its vast resources to lobby and advertise against it. A deal with the devil, perhaps, but there's nothing pure or angelic about politics.
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But that's what worries me. Obama stated that he would make the health bill negiotations transparent and even broadcast the Congressional discussion on C-SPAN. That hasn't really happened. I think it's unrealistic to expect lawmakers to go on camera with their various proposals and deals anyway. But there shouldn't be such secrecy with the industry reps either. You're right that the White House initially denied any PhRMA deal, but the Huffington Post obtained a leaked memo, and later the WH eventually admitted to it, as reported by the LA and NY Times.
http://www.nytimes.com/2009/08/06/health/policy/06insure.html?_r=1
It shows disrespect for the public when he claims to shun lobbyists and keep the people first, yet he practices politics as usual (well, not as bad as Cheney and the oil companies at least). Who knows what deals are going on with doctors and insurers now? As you said, Obama needed to get PhRMA on his side of the health debate (or at least not fighting him tool & nail), but that hush-money comes at a huge price. He claims $80B in drug savings over 10 years (meager vs. the total cost of the health bill), but he's also protecting PhRMA's $1 trillion/year (and rising) bloated revenues. Like loan sharking, getting a little now, but paying a lot later. And obviously no business would agree to a deal unless it was a net gain for them (AOL-Time Warner notwithstanding haha). PhRMA's financial analysts are a lot better, and better paid, than Obama's.
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"The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas manufacturers of active pharmaceutical ingredients such as heparin."
Currently the FDA expects companies to inspect their foreign subcontractors or facilities, and report findings to them. The FDA only has the resources to inspect US sites like once every 1-2 years anyway.
The Chinese case was just plain counterfeiting. They usually sell heparin derived from pig blood, but in the case of Baxter's subcontractor, they diluted the heparin with cheaper, heparain-mimicking chondroitin sulfate from shellfish. So there were allergic reactions and deaths of patients who can't handle shellfish proteins or chondroitin.
http://www.cbsnews.com/stories/2008/03/01/eveningnews/main3896578.shtml
http://www.drugrecalls.com/heparin.html
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