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“Right to Try” Is the Right Step for States

e21 | 06/19/2014 |
“Right to Try” Is the Right Step for States

Does the government have the right to tell terminally-ill patients they cannot try treatments that have the potential to save their lives? The U.S. Food and Drug Administration says yes, but Arizona’s Goldwater Institute believes denying treatments infringes on the natural right to life. The Institute is working through state governments to provide hope to those facing an uphill battle for survival.  

Rapid advancements in understanding of the human body, specifically the human genome, offer doctors new tools to combat fatal diseases. However, the FDA has been slow to adapt to this new reality. Its outdated regulatory structure is constraining medical progress and harming patients. 

The FDA’s requirement of large-scale medical trials, the best tools available when doctors had little to no understanding of the human genome, now serve as a barrier to progress. 

People’s genes are extremely diverse. What works as a miracle cure for one patient most likely will not for another, and that is the point with modern medicine. Manhattan Institute senior fellow Peter Huber, author of The Cure in the Code, says the FDA needs to embrace individualized cures if there is any hope to cure diseases such as Alzheimer’s. 

FDA’s spending increased 65 percent in real terms between 2008 and 2012 and by more than 270 percent between 1990 and 2012. Even with greater funding the FDA has been unable to keep up with medical innovation. Instead, it added more than 1,000 regulations restricting individuals’ behavior between 2008 and 2012. An unintended consequence of these regulations is that they constrain medical progress rather than encourage development of lifesaving medicine. 

FDA policies create an environment where new, experimental drugs cannot help sick Americans. It usually takes between 10 and 15 years to get FDA approval for a new drug. Terminally-ill patients do not have 10 years to wait for treatment. Gaining FDA approval also costs an average of $800 million. Pharmaceutical companies know the immense financial, time, and uncertainty costs associated with gaining FDA approval. Because of this, they often hesitate to bring potentially-helpful drugs to market.

Exemptions to the requirement of FDA approval can be made for terminally ill patients, but they are rarely granted and are difficult to obtain. Doctors have to complete over 100 hours of paperwork, and it is difficult for average families to navigate the FDA’s convoluted process.

 

Source: Goldwater Institute

The federal government has been reluctant to force necessary reforms on the FDA, even as modern medicine has completely transformed healthcare. In the face of federal inaction, the Goldwater Institute is pushing state legislatures to enact “Right to Try” measures—legislation allowing terminally-ill patients to try drugs that are not yet approved by the FDA.

As the Goldwater Institute says:

Patients should be free to exercise a basic freedom—attempting to preserve one’s own life. The burdens imposed on a terminal patient who fights to save his or her own life are a violation of personal liberty. Such people should have the option of accessing investigational drugs which have passed basic safety tests, provided there is a doctor’s recommendation, informed consent, and the willingness of the manufacturer of the medication to make such drugs available.

The Institute has already seen some successes. Colorado, Louisiana, and Missouri approved Right to Try legislation unanimously. Arizona voters will face a ballot initiative this fall. When people hear emotional stories from parents who were banned from doing everything possible to save their children, they realize that allowing access to potentially life-saving medication is not a partisan issue. 

Patients with terminal illnesses and their families are desperate. Today, bureaucrats have the legal authority—if not the moral authority—to tell a dying cancer patient they cannot take a one-in-a-hundred chance and try an experimental drug. The Manhattan Institute’s Project FDA released a video that highlights just how devastating such restrictions can be. 

What does it matter to those who are otherwise going to die if the drugs they are taking are not proven to be 100 percent safe and effective for everyone? Tragically, the terminally ill have no other options. Taking experimental drugs at worst provides the sick with hope, and at best saves lives and provides more data on the drugs’ effectiveness.

Decisions regarding one’s life should be left between patients and their doctors—unelected federal bureaucrats should not stand in the way. The FDA must realize it needs to modernize and stop interfering with the fundamental right to life. If it does not, states are more than justified in taking matters into their own hands and passing The Goldwater Institute’s Right to Try legislation.

 

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