The Soapbox

111Balz

Joined: 08/13/1998 Posts: 59689
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Or you could actually invest a minute or two to get informed - link


"The FDA already has a program in place, the Expanded Access Program, that grants terminally ill patients access to investigational drugs. Scott Gottlieb, commissioner of the FDA, said at a congressional hearing in October that the FDA authorized 99% of the more than one thousand requests "in recent years."

"Emergency requests for individual patients are usually granted immediately over the phone and non-emergency requests are generally processed within a few days," he said."

"While the bill cleared the Senate easily, it faces stronger opposition in the House. The top Democrat on the Energy and Commerce Committee, Rep. Frank Pallone, issued a statement Monday blasting the bill as needless legislation that undermines the FDA's approval process and gives patients "false hope," since it doesn't require manufactures to actually provide the drugs to the patient.

Critics also fear the legislation could carry broader implications and lead to a slippery slope of bypassing FDA regulations for less urgent cases, such as those with chronic illnesses, for example.

"It's all well and good and it seems like a nice thing to do for patients, but it's actually probably not going to open up much access to them than what the FDA already approves," said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania. "The bigger challenge is this attack on the FDA's very reason for existence." "


(In response to this post by Tuckahokie)

Link: https://www.cnn.com/2018/03/13/politics/right-to-try-house-bill/index.html


Posted: 03/15/2018 at 08:16AM



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Current Thread:
 
  
Why was the "Right To Try" bill shot down?** -- Hokie5150 03/14/2018 6:15PM
  No, that's not actually it -- Beerman 03/15/2018 09:33AM
  Why would Big Pharma be against the bill? ** -- 111Balz 03/15/2018 09:56AM
  Cost assurance -- Beerman 03/15/2018 10:05AM

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