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Compliance In Focus
Posted by Natalie Jarmusik on Thu, May 22, 2014

The “Right to Try”- Promoting the Right to Choose Experimental

String the letters F-D-A together and almost instantly you’ll picture the well-recognizedThe “Right to Try”  Promoting the Right to Choose Experimental scientific safe-haven of the United States. Formed in 1906, the Food and Drug Administration was created to ensure the responsibility and protection of US citizens’ interaction with the market of commercial science. From cosmetics to veterinary medicine, the FDA regulates and supervises the advances that intend to make life more manageable. However, in Colorado terminally ill patients are advocating for a little liberation from this tight hold the FDA so often advocates when regarding human subjects.  As of May 17, 2014 Colorado is officially the first state to grant patients access to experimental pharmaceuticals still resting in the developmental pipeline - ones either awaiting or working towards federal approval for lawful commercialization.

The “Right to Try” law, as it has been named, was inspired by Nick Auden, a melanoma patient from Denver who died while seeking federal permission to take experimental drugs outside of clinical trial supervision. And despite Auden’s acknowledgment that no guaranteed benefit could be promised from taking these pharmaceuticals, neither of the two companies Auden contacted agreed to provide him with any such means of therapy. Now in several other states similar bills have been drafted and await signatures of approval from state governors; meanwhile a debate over the effectiveness of such a bill has begun to develop.

When you consider why the FDA was originally created, the restriction on access to experimental drugs seems reasonable, possibly welcome, in an effort to retain the best-interest of human subject health. But imagine if you or a family member were diagnosed with a terminal disease, discovering you only had months to live with no government-approved therapy on the market – the FDA guidelines on ‘compassionate use’  or ‘expanded access’ to an experimental treatment lying outside of a clinical trial might seem frustrating – even unfair.  That is why so many regard this bill as a ray of hope for dying patients asking to obtain drugs outside of clinical trials as a last-resort option. But would a pharmaceutical company with millions of dollars already invested in the development of a drug really risk its therapeutic reputation and integrity by sending it outside of the clinical realm? Officials say no company is required to supply their experimental drug upon request and the bill received a reserved “no-comment” from hospitals, health insurers, and state doctors’ groups upon its passing -a possible indication of skepticism as to the effectiveness of such a bill.

Regardless, the Right to Try law is a perfect example of the continuing struggle to discover solutions to human health problems that pose minimal risk to the safety of an individual. And though the outcomes of such a law have yet to be determined, the right to choose experimental will certainly leave its mark on the progression and development of clinical research. The question now is:

What kind of mark will that be?

What are your thoughts on the Right to Try law?

Photo Credit: aarongilson

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Topics: Right to Try Law, Choose Experimental, FDA


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