The medical device tax repeal: The good, the bad and the ugly
When $30 billion dollars are injected into the device industry, it will stimulate the good, the bad and the ugly all the same
Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD.
Philadelphia Enquirer
February 18, 2015
Recently we’ve been getting some feedback from medical device industry advocates.
Ironically, this feedback did not come when we started to raise an alarm about the severe patient safety hazard the device industry’s federal regulations have caused. Rather, it came when we raised a significant concern about providing this unsafe industry a tax advantage – the so-called “medical device tax repeal”.
You see, giving a financial boost to an industry whose products have virtually no standardized guarantee of safety, is wrong...
We do believe that a vast majority of
medical devices in our country are designed to be ‘life saving’ – and to
make a good profit for their manufacturers. We are not against industry
or profits. But, a minority subset of these devices are faulty, in
design or conception – as the power morcellator is.
And no real federal safety checkpoints are in place to protect
unsuspecting patients. Doctors and device reps are the only things that
stand between the patient and this monster we call “harm” – and that’s
just not acceptable.
When $30 billion dollars are injected into the device industry, it will stimulate the good, the bad and the ugly all the same. And when the bad and the ugly in the medical device realm have no real federal safety checkpoints and are stimulated to grow, they devastate unsuspecting patients’ lives in America.
The real problem in the medical device industry comes from the corrupted way in which the Food and Drug Administration is using the 510(k) law to clear the vast majority of medical devices in the United States. This legislation was never designed for this purpose and it was certainly not designed to ensure patient safety. But, with definitive certainty, the way to protect patients from an industry gone rogue due to defunct federal regulation, is not to boost it with a sizable tax advantage.
So, our response to our friends and colleagues in the medical device industry when they tell us to “keep ‘em separated” is: Help us drive a leadership overhaul of the FDA’s Center for Devices and Radiological Health by congress. Help us make a “Medical Device Safety Reform Act” a reality and the law of this land. Only then can we help you achieve your tax repeal, stimulate your industry and create your jobs.
When $30 billion dollars are injected into the device industry, it will stimulate the good, the bad and the ugly all the same. And when the bad and the ugly in the medical device realm have no real federal safety checkpoints and are stimulated to grow, they devastate unsuspecting patients’ lives in America.
The real problem in the medical device industry comes from the corrupted way in which the Food and Drug Administration is using the 510(k) law to clear the vast majority of medical devices in the United States. This legislation was never designed for this purpose and it was certainly not designed to ensure patient safety. But, with definitive certainty, the way to protect patients from an industry gone rogue due to defunct federal regulation, is not to boost it with a sizable tax advantage.
So, our response to our friends and colleagues in the medical device industry when they tell us to “keep ‘em separated” is: Help us drive a leadership overhaul of the FDA’s Center for Devices and Radiological Health by congress. Help us make a “Medical Device Safety Reform Act” a reality and the law of this land. Only then can we help you achieve your tax repeal, stimulate your industry and create your jobs.
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