Monday , January 12, 2015 - 8:24 AM2 comments
The Declaration of Independence states that we have the inalienable right to “the preservation of life.” This right is one of the most fundamental values on which we’ve built our Republic.
And yet, each year, for thousands of terminally ill patients the government limits and forecloses their options to take affirmative steps to preserve their lives.
There are thousands of potentially lifesaving drugs and treatments bogged down in the red tape of the seemingly never-ending FDA approval process. On average, it takes 10-15 years and hundreds of millions of dollars for drugs to get through the FDA’s multi-phase approval process and finally become available to the public.
While the FDA has an important role in keeping harmful or ineffective drugs off the market, its processes are so slow and cumbersome that it often keeps new drugs from patients that could extend and preserve their lives.
‘Right to Try’ legislation, like that enacted last year in Arizona, Colorado, Louisiana, Missouri, and Michigan and now proposed in Utah in House Bill 94, provides terminally ill patients an alternative route to access experimental drugs not yet fully approved by the FDA.
HB 94 gives terminal patients who have exhausted conventional treatment options and consulted with their doctor to access drugs that have successfully completed Phase I of FDA testing. A drug passes Phase I when the FDA has determined it to be reasonably safe for human trials.
In short, HB 94 gives new hope to those previously without hope.
We anticipate two groups of patients likely to seek these currently restricted drugs: those who want to fight to extend or save their own life and those who accept their fate but want to further drug testing for others with the same illness.
As witnessed in the Ebola outbreak, there are real, lifesaving implications to granting limited exceptions to the FDA’s rules. The FDA allowed seven Americans diagnosed with Ebola to take the experimental drug ZMAPP. Some of these patients recovered from the lethal disease. By allowing access to ZMAPP, a drug that had not completed the FDA approval process, these lives were saved.
We acknowledge that clinical trials provide some terminally ill patients the hope they seek; however, many of the sickest individuals do not qualify to join such a trial. For these patients, their only hope to access these potentially life-saving drugs is to request that the FDA grant them expanded access. This is a cumbersome process which takes hundreds of hours of paperwork by the patient’s physician with no guarantee of getting expanded access. HB 94 makes the process much easier.
Medical decisions, especially those of terminally ill patients, should be made by patients and their doctors, not Washington bureaucrats. HB 94 gives terminally ill patients the right to make their own decisions regarding preservation of life.
Gage Froerer is a member of the Utah House of Representatives from Huntsville, Utah and the sponsor of HB 94. Jonathan Johnson is the Chairman of Overstock.com, Inc. and Promote Liberty PAC.
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