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It's Time to Flatten the FDA

No, I don't mean with a right hook or an uppercut. Just make the FDA and other health authorities around the world adopt the same rules to promote better healthcare. It's a tall order, but about time, according to AdvaMed Executive VP Ralph Ives. (AdvaMed is an advocate organization in Washington D.C. for medical-device makers.) Healthcare suffers when well-meaning authorities try to control costs with rules that vary from organization to organization.

Here's just one indicator that things are out of whack: A spokesman for a medical-device company said that its recent invention for killing pathogens in blood, developed in the U.S., was in its first clinical trials in France. Why there? Because FDA's regulations make trials here too onerous.

Such obstructive bureaucracy flies in the face of world medical trends and hence calls for a world solution. It's time for a leveling and lowering of regulations because people expect and deserve improvements in the quality of their healthcare. A full 82% of voters say health care is high priority and will affect how they vote in midterm elections.

Despite growing expectations, there's a big gap between what patients need and what they get. For instance, Ives complied a list of 30 medical conditions for which many U.S. patients do not receive recommended care. For example, almost 60% of people who contract urinary tract infections don't receive proper care. The figure climbs to almost 80% for those with fractured hips. “Things are no different in the U.K., Europe, or Japan because governments supply most of the funding,” says Ives. “Medical costs are a significant slice of GNP: 15% in the U.S., 11.1% in Germany, and 10.1% in France, to name the top three.”

To fight rising costs, many countries are adopting the idea of diagnoses-related groups and unwittingly driving costs higher. Ives says DRGs work like this: governments pay hospitals for a fixed number of treatments and a fixed amount for each patient stay. This supposedly encourages competition for better care and lower costs. What really happens is that people wind up waiting two years for a hip implant, a common occurrence in Canada and the U.K.

Take the Japanese system, for example. Since 2002, it has been monitoring prices from the U.S., U.K., France, and Germany on procedures and equipment. It then dictates the lowest figures as its reimbursement level. It almost never raises them for better, safer, or more effective medical technologies in its market.

And fixing prices discourages the introduction of new technology. As costs increase and revenues decline in Japan, products are delayed or pulled off the market. In 2002, medical companies there filed applications for 132 new products. In 2004, the figure dropped to 58, and in 2005 it fell to eight. And it's happening elsewhere, says Ives.

Governments are also adopting more safety and efficacy regulations. Few would debate the need for sound regulations, but many government organizations force device companies to duplicate time-consuming and costly studies before marketing their equipment in a new country. So if you want to sell a life-saving device in 10 countries, you might have to conduct 10 clinical trials. What's worse, governments are lousy long-term planners so touting long-term savings falls on deaf ears.

To flatten things faster, it might make sense for associations of medical-technology companies to promote several ideas. The most important is that medical-device makers are one solution to healthcare problems because new devices lower costs. Early diagnoses, for example, cuts illness severity and treatment costs. Less invasive treatments cut hospital stays. Devices account for only about 5% of the $220 billion world healthcare market. But new procedures are often not reimbursed though they save money in the long run.

Government organizations need to see that good ideas and products bring down costs. In fact, a few dozen examples of just that are available at progress youcansee.org. Now, if government healthcare workers will only read it.

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© 2012 Penton Media Inc.


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