Right to Try Legislation: What You Need to Know

             The legislation allows patients with life-threatening conditions to take unproven medications without the approval of the FDA

On May 30th, the president signed a bill, commonly referred to as “Right to Try Legislation,” into law during a ceremony at the White House. Attendees of the signing event included several individuals who are afflicted with rare and life-threatening conditions. These individuals, their family members, and other supporters of Right to Try are encouraged that the law empowers them to try unproven medications that have not yet made it through the FDA authorization process. Instead, these medications are still in the early trial phases and have only received basic initial testing for safety.

Basic Premise of Right to Try: At its core, the legislation allows patients with life-threatening conditions to take unproven medications without the approval of the FDA. The law stipulates that the patient must have exhausted all other approved treatment options and not be eligible for any experimental drug trials. If those conditions are met, the patient must have consent from their physician and also the drug manufacturer.

Why is Right to Try necessary? Supporters and critics disagree on this point, but essentially, patients have had access to experimental drugs in the past by applying for an exception called compassionate use or expanded access. Right to Try advocates claim that the application process is too burdensome while critics point out that 99.4% of compassionate use applications are approved. The new legislation streamlines that process by limiting the decision-making process to the patient, physician, and drug manufacturer.

Impacts on the Pharmaceutical Industry: Right to Try is designed to protect manufacturers from liability concerns should a patient be harmed by an experimental treatment. There is a concern in the pharmaceutical industry that unforeseen incidents have the potential to compromise the approval process as they continue to develop these treatments. Smaller Biotech firms have raised concerns that the legislation may hinder their ability to keep supplies of experimental treatments available, as they typically only have enough on hand for the clinical trials they are engaged in for FDA approval.

Physicians weigh in on Right to Try: The federal legislation has a provision protecting doctors if adverse events occur through the administration of an experimental treatment. Many doctors have opposed the bill, not because of any negative impact on themselves, but on a perceived weakening effect on the FDA.

What Advocates Say: According to the Goldwater Institute, a leading advocate behind Right to Try, the new law is necessary because the vast majority of terminal patients cannot participate in ongoing clinical trials. Advocates also point to the cost and time-consuming nature of the FDA compassionate use program, where a single application may cause a doctor to spend over 100 hours justifying the patient’s need for treatment.

What Critics Say: When asking an opponent of Right to Try for a reason behind their stance, the first response is typically that the legislation is peddling false hope. They express concern that unscrupulous companies that are out to make a quick buck and without undergoing rigorous FDA scrutiny, will put patients at risk of unnecessary pain and quicker death due to unproven therapies. Another concern for critics is that the lack of safety data regarding an experimental treatment will hinder the informed consent of patients who are seeking the therapy.

With the Right to Try legislation passed, what are your thoughts on this measure? Do you have an opinion about how Right to Try is going to impact your career as a medical professional? Share your thoughts about this politically charged topic in the comment section below or join the discussion on our Facebook page.

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