Newspaper article Charleston Gazette Mail

FDA Regulations Block Innovation ; Past Inventors Didnt Face Millions in Fees to Get Their Products to Market

Newspaper article Charleston Gazette Mail

FDA Regulations Block Innovation ; Past Inventors Didnt Face Millions in Fees to Get Their Products to Market

Article excerpt

Im gonna science the s#!t out of this planet. So says the fictional character Mark Watney in the sci-fi thriller The Martian, which has grossed a half-billion dollars worldwide. For every conceivable thing that goes wrong on the Red Planet, the botanist astronaut comes up with an answer. Its a good thing Watney was on Mars, because he would find sciencing much more difficult on his home planet.

Some of Americas most famous inventors felt like they also could overcome any odds. Benjamin Franklin invented bifocal glasses and the flexible urinary catheter. Jonas Salk invented the vaccine for polio, a disease that put President Franklin Roosevelt in a wheelchair. Salk tested it on his own wife and three sons before testing it on the nation in 1954.

Then there was Marion Donovan, the daughter of an inventor who grew up with her fathers can-do spirit of solving problems. She invented disposable diapers in 1950. Yet today, they might be classified as class 1 medical devices, like reusable menstrual pads so she would have to pay a registration fee of $3,313. We celebrate inventors in this country and even have museums dedicated to them like the National Air and Space Museum and the American History Museum.

But at the same time we celebrate them and enjoy all the benefits of modern invention, we impose obstacles that probably would have sunk many of these early inventors.

For those who invented drugs or medical devices, the obstacles they face today are milehigh mountains when compared to the ant hill of just finding a solution for a problem.

If Salk invented a new drug today, he would have had to raise an average of between $500 million to $2 billion, of which most is spent on FDA drug trials. For the one in 5,000 drugs that actually make it to market, it takes about 12 years to go from the lab to the drugstore, eight years longer than Salk took for his polio vaccine.

Marion Donovan and Ben Franklin may have had it somewhat better than Salk, but there are still enormous hurdles. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.