F.D.A. Deal Would Relax Rules on Reporting Medical Device Problems

[Eugene]

Source: New York Times

F.D.A. Deal Would Relax Rules on Reporting Medical Device Problems

By SHEILA KAPLAN JULY 11, 2017

WASHINGTON — Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress.

Device makers will still have to quickly report any injuries or deaths related to their products. They would have more time, though, to file reports on devices that may not be working properly, and have the potential for injury.

The deal is part of a pact between the F.D.A. and the $148 billion device industry. Renegotiated every five years, the agreement includes the fees that device makers must pay for the agency to review their products. It is scheduled for a vote in the House of Representatives on Wednesday.

The current draft compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever. But, at a time when the F.D.A. acknowledges that medical device mishaps are vastly underreported, a provision in the bill says the agency should permit companies to report malfunctions every three months, rather than the current practice of submitting reports within 30 days of a problem.

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Read more: https://www.nytimes.com/2017/07/11/health/fda-medical-device-problems-rules.html

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1. Relaxing Reporting Of Medical Device Mishaps Is Dangerous.....

such mishaps raise the cost of our health care and insurance premiums. Stringing reporting out longer will just cause more people to suffer and maybe even die - and treating these mishaps after the fact cost money. We need to know as soon as possible about medical device failures. We're going in the wrong direction on this.

Yes - I'm sure the device manufacturers are ok with this - but the FDA is there to protect the American People from such incidences. Relaxing the reporting is contrary to what the FDA is all about.

Note that I spent close to 50 years in the pharmaceutical and medical device industry. From time to time I've run into some unscrupulous people at all levels of management of these companies. All one has to do is to look over the specifics of medical device recalls over the years to see the implications of a medical device mishap and decisions/or lack of decisions made because of the financial implications to the offending device/company.

I know the Party in power is for relaxing all sorts of regulations. This is one that just shouldn't be relaxed.

Knowing that this same Party is out to take health care and health insurance back to the past - this decision by the FDA to relax reporting should be taken into consideration in the CBO's analysis of this alternative to ACA that is being proposed.

I personally believe that it will be costly to the system and it will raise the price of health care insurance premiums if it is allowed to be passed.