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'Right-To-Try' Laws Allow Use of Still-Unapproved Drugs

When people suffer from a terminal illness, it's understandable that they and their loved ones are willing to try just about any drug or treatment that could help them. This includes drugs that have not yet received approval from the Food and Drug Administration. That approval process can take a decade or more.

However, understandably, pharmaceutical companies and physicians are concerned about the legal ramifications if an unproven treatment goes wrong. That's why some states are passing "right-to-try" laws.

These laws protect drug manufacturers, medical facilities and physicians from prosecution. Perhaps more importantly, they help facilitate access to drugs and treatments that are not yet FDA-approved for terminally-ill patients. Both houses of the Florida legislature have introduced right-to-try bills.

There are other ways that patients can access experimental treatments, such as the FDA's compassionate use process. However, that process can be long and time consuming. Clinical trials are another alternative for some, but it can be difficult to qualify for one.

Right-to-try laws allow doctors to go directly to pharmaceutical manufacturers to discuss the potential risks and benefits of the drug once it has passed the first stage of FDA approval. This stage is to determine whether a medical device or drug can cause harm. In the latter two stages of approval, the FDA determines whether the benefits outweigh the risks.

Drug companies are under no obligation, however, to provide the treatment at that stage, and many are reluctant to do so. A spokesperson for a pharmaceutical industry trade group says that they "have serious concerns with any approach to make investigational medicines available that seeks to bypass the oversight of the FDA and clinical trial process."

Bioethicists have mixed views and conflicting emotions about right-to-try laws, and the FDA has taken no official position on them. Further, even one advocate for more widespread right-to-try laws admits that he knows of no case where a drug obtained under a right-to-try law has proven successful. However, he notes that many people are not aware of the laws.

While federal regulations can indeed be onerous, they are in place for a reason. However, if a patient is facing a terminal diagnosis and a qualified physician who has done due diligence on the risks and benefits of a treatment for that specific patient, an argument can be made that the patient should be allowed to proceed with it.

Source: U.S. News and World Report, "Seeking the Right to Try," Kimberly Leonard, accessed March. 31, 2015

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