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The Hidden Act: 21st Century Cures Act

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After the United States Senate overwhelmingly approved the bill (94-5 vote) what is called 21st Century Cures Act, that would cost around $6.3 billion medical research that support the package including Federal Drug Administration (FDA) reforms. The bill’s idea was brought by Rep. Fred Upton from Michigan, a Republican. In the bill outline:

TITLE I–DISCOVERY

Subtitle H–Council for 21st Century Cures

(Sec. 1141) The Council for 21st Century Cures, a nonprofit corporation, is established to accelerate the discovery, development, and delivery of innovative cures, treatments, and preventive measures.

Could it also interpret for Deaf children to be cured and offer through cochlear implant package because of the discovery, development, and delivery of innovative cures, treatments and preventive measures (to prevent Deaf babies again)—or maybe it could mean they want to cure genetics and stop the state of being Deaf.

TITLE II—DEVELOPMENT

(Sec. 2181) The FDA must describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.

“Medical devices, or biological products when reviewing a product that is a combination of….medical device”—the medical device, could it be cochlear implant since it is a medical device.

(Sec. 2201) The FDA must establish a program for priority review of breakthrough medical devices. 

“A breakthrough medical devices”—could be dangerous loophole to cure Deaf people today. Today there are even Deaf people with cochlear implants who pretend that they are above such mundane concerns as recognizing and preparing for the intellectual life.

(Sec. 2222) “Valid scientific evidence” is defined for purposes of the FDA determining the effectiveness of a medical device without clinical investigations.

Remember 1989 FDA approval of cochlear implant surgery where 12 Deaf children died from the complications of cochlear implants or even during the surgery procedure itself. After all, CI is “a permanent token of mourning”—that being Deaf is inevitable!

Quite frankly, we should be seriously concerned about this bill, 21st Century Cures Act that the Deaf community needs to be known about this. How come we did not inform about this until now? Why are Deaf people being shunned from the information something like this? The bill now sends to President Obama’s desk with hopes for his signature.

–JT

Copyright © 2016 Jason Tozier

This text may be freely copied in its entirely only, including this copyright message.

References:

https://www.congress.gov/bill/114th-congress/house-bill/6

http://www.politico.com/story/2016/12/senate-approves-medical-research-cures-act-opioid-cancer-232330?utm_source=nl-politics-daily-120716

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