The FDA is out of control and something needs to be done.

Recently, a respected Rhode Island medical practice fell under health department scrutiny for admitting it was implanting contraceptive intrauterine devices (IUDs) manufactured in Canada in some patients.  The devices seem to work efficiently and have apparently not caused complications: Canadian women by the tens of thousands are using the same devices, but the IUDs are not approved by the sacrosanct Food and Drug Administration (FDA). That, apparently, is the problem.

The US FDA was officially formed in 1906 to oversee food processing in this country after abominable conditions in those plants came to light. In 1938 the agency formally took on oversight of drugs and pharmaceuticals, and eventually cosmetics and medical procedures (radiology tools etc.) fell under its purview as well. Where approval and regulation of prescription drugs are concerned, however, the agency faces increasing criticism for the cost of those drugs to consumers. Drug companies blame the high cost of rigorous research and trials required for FDA approval.

But the bulk of the outrageous cost of drugs in the US stems from industry greed. There is no reason why a drug manufactured in France or Great Britain, with the same formula and ingredients as the US equivalent, sells for anywhere from two to 500% more in the States.

In the Rhode Island IUD case, greed is everywhere. Doctors were buying devices at half the usual IUD costs.  They then implanted them and billed patients' insurances for the full cost of an FDA approved IUD (twice as much as the Canadian cost.)  The insurance companies paid for the higher cost (but, more importantly, they do not lobby the FDA to approve cheaper foreign alternatives thereby creating significant savings for insurers as well as patients.)

The IUD in question, manufactured by Bayer Healthcare Pharmaceuticals, has a US equivalent manufactured by the same company-- at twice the price!  So Bayer apparently blew the whistle on OB-GYN Associates because it was challenged in its own two-market game.

It's about time the federal government took a good hard look at the FDA budget ($4 billion in FY 2011.) Any consumer can tell them the cost of prescription drugs and diagnostics in this country is out of control when compared with other countries. It is insane as well as fiscally irresponsible to assume that drugs and/or procedures used on thousands of people in Switzerland, Canada, or Sweden, for example-- over a period of years-- cannot guarantee safety to US patients. The redundancy of FDA trials on already-tested drugs in other equally capable countries wastes time and money and punishes US consumers with unnecessary costs.

The myth that America has the best medicine or is the only country where purity of foods and drugs can be assured is absurd in 2010. The World Health Organization still ranks US health care as 37th in the world-- worse than Morocco, Chile and Costa Rica. France and Italy rank first and second, for example, and Canada is seven places ahead of the US at 30. This list measures quality care and the cost to deliver that care.

It is about time US citizens stopped being held hostage by an FDA system that harms the public more than it helps where prescription drugs are concerned. There is too much room for waste in the current system, too much disregard for global science, and, frankly, too much room for pharmaceutical money to change hands to keep their profits soaring.

Maybe if the favored oil companies can ever clean up the Gulf, bankers can be reined in and two useless wars can get shut down the feds can turn their attention to ways to save taxpayers some money rather than squandering more. But that is like hoping that big business and what Eisenhower called the "military industrial complex" will stop bribing politicians who care more about power than about the citizens they are elected to serve.