Wednesday, July 2, 2008

The US Healthcare Industry Facing Challenges – Is It?

Over the past couple of days developments on the issue of ensuring patient safety have left the providers of health care in the US scratching their heads.

Just a couple of days earlier the buzz about the congress introducing the legislation on medical device safety (the proposed “Medical Device Safety Act 2008”) was rife, and it still is. The new legislation would enable the medical device manufacturers to be held accountable in cases where medical device causes harm.

And now it's the talk of newer rules that would make getting approvals for diabetes drugs a much longer process than it presently is.

The Medical Device Safety Act 2008 - Implications

The amendment is widely being seen as an instrument that serves as an extension of patient rights and interests. Upto now, once medical devices secured clearance from the FDA, the makers couldn't be sued under state laws. A recent Supreme Court Ruling highlighted the fact wherein the consumers weren't able to seek compensation for injuries, medical expenses, etc. This was because if the manufacturers were sued under state laws then there would be a conflict between the federal and the state laws, which isn't allowed.

With the FDA clearance of medical devices being stripped off its “stairway to heaven” status, the manufacturers would need to introduce many measures to leave no stone unturned in ensuring quality production.

However, a contention was raised that if a patchwork approach is employed for medical device approvals it would lead to conflicting labeling and indications on products.

Further, that more lawsuits and delays in newer technologies reaching patients would eventually raise health care costs.

Diabeties Drugs – Tougher Rules

The issue has caught limelight following a proposal by a renouned cardiologist from the advisory panel in the US, to further test the new diabetes drugs for heart safety.

Reportedly, the drugs could be subject to long term testing, in case short term testing raises red flags. Again, this brings up the issue of diabetes drugs becoming costlier to manufacture, and the extra baggage would naturally be passed on to the consumers.

A second concern is that of quick availability of drugs. Given the present proposal, lag times of upto a year are expected, which could possibly make companies wary of manufacturing diebetes drugs.

So it seems that there are some tough challenges that the American industry is up against. Now, only time will tell how the health care providers strike a balance between economics, legislation and patient safety concerns.

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