Posted On: 03/05/2016 11:39:19 PM
Post# of 30015
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Thinking about the upcoming ESS trial and how the fda and drug companies have responded to so-called 'compassionate use' requests. From wsj:
Quote:http://blogs.wsj.com/pharmalot/2015/06/10/thi...bola-drug/
Toward that end, the [Goldwater] Institute has worked with several states to develop so-called “Right to Try” legislation. These laws, which have been passed in more than a dozen states, allow patients and doctors to obtain experimental drugs without asking the FDA for permission to gain access. Legal experts, however, question whether the laws will be effective and believe the FDA is not an obstacle
The FDA, in fact, has a strong track record for approving compassionate use requests, which are rising each year. During the most recent fiscal year, the agency signed off on 99.5% of nearly 1,900 requests received. More than half were considered emergencies. Agency officials have repeatedly noted that drug makers have the option to deny requests that are approved by the agency.
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