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Too Much Regulation?

<br> <P>Is too much regulation in the US hazardous to your health?<br></P>

MILLIONS OF AMERICANS RELY ON THE F-D-A TO TELL THEM WHICH DRUGS AND DEVICES ARE SAFE ENOUGH FOR USE.
SOME SAY THE APPROVAL PROCESS IS TOO STRICT AND TAKES TOO LONG.
MARTI CONGER WAS ON THE VERGE OF PARALYSIS.
 TWO DEGENERATIVE DISCS IN HER SPINE LEFT HER IN SEVERE PAIN. SO MARTI DID HER RESEARCH AND FOUND A FACTORY JUST OUTSIDE HER OWN CITY THAT MANUFACTURES DISC IMPLANTS.  BUT THEY ARE NOT F-D-A APPROVED IN THE U-S. THEY WERE APPROVED IN EUROPE IN 2005!
"I ended up going to Southern England and getting a device that's made 40 miles from here."
DEVICES LIKE MARTI'S ARE BECOMING AVAILABLE YEARS EARLIER IN OTHER COUNTRIES. THE CYPASS MICRO-STENT - A TREATMENT FOR GLAUCOMA - HAS BEEN APPROVED IN EUROPE FOR THREE YEARS BUT IS NOT EXPECTED TO BE F-D-A-APPROVED FOR ANOTHER FOUR. DOCTOR DAVID CHANG BELIEVES THE F-D-A'S APPROVAL SYSTEM NEEDS WORK.
"The process has just become overly burdensome, overly predictable, and overly time-consuming."
THE F-D-A STANDS BY THEIR CAREFUL -- AND SOMETIMES LONGER -- APPROVAL PROCESS FOR HIGH-RISK DEVICES. AND IN A WRITTEN STATEMENT TO US, THE F-D-A SAID THEY ARE WORKING WITH OTHER COUNTRIES TO CREATE A "NEW INTERNATIONAL FORUM TO ACCELERATE AND EXPAND EFFORTS TO HARMONIZE DEVICE REGULATORY SYSTEMS AND TO SHARE BEST PRACTICES." 
SINCE HER OVERSEAS SURGERY MARTI'S BECOME A PATIENT ADVOCATE EVEN TESTIFYING BEFORE CONGRESS FOR AN F-D-A OVERHAUL.
TOO MUCH REGULATION OR NOT ENOUGH? IT'S A QUESTION WITH NO EASY ANSWERS.
DOCTOR CHANG SAYS THE LENGTHY APPROVAL PROCESS HAS MORE AND MORE MEDICAL MANUFACTURING COMPANIES MOVING ABROAD - AND MARKETING THEIR PRODUCTS IN OTHER COUNTRIES FIRST.  
HE ALSO SAYS THE COST OF APPROVAL IS ABOUT HALF IN EUROPE AS IT IS IN THE U-S.
MEANWHILE, THE F-D-A POINTS OUT U-S PATIENTS HAVE ACCESS TO LOW AND MODERATE RISK DEVICES AT LEAST AS EARLY AS PATIENTS IN EUROPE.
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