On May 30, 2018, President Donald J. Trump signed S.204: the "Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017" (whew) into law. The Right to Try (RtT) legislation gives terminally ill patients who've exhausted all approved treatment options and aren't able to participate in a clinical trial, the right to work directly with drug companies for access to investigational new drugs (IND) that haven't secured approval by the U.S. Food and Drug Administration (FDA).
The law's intent is to make the process of obtaining potentially life-saving drugs (completely untested by the FDA) easier on the whole by avoiding the FDA altogether. In response to previous statements by FDA Commissioner Scott Gottlieb, M.D., regarding how the agency intends to implement the law — especially as it relates to new regulations that oversee patient safety and protection under Right to Try — the main proponent of the bill, Senator Ron Johnson (R-WI), wrote in a letter to Gottlieb that the goal of Right to Try is to "diminish the FDA's power over people's lives, not increase it."
Critics, including physician's and ethicists, worry that the lack of oversight may make vulnerable, end-of-life patients more susceptible to purveyors of false hope and opportunistic companies who could take advantage of them financially. Supporters contend that it will provide a pathway to new treatment options for dying patients who have exhausted all the alternatives. But the bottom line is that the pharmaceutical company gets the final say about whether to provide a drug or not.
"Right to Try does not give any 'new' rights or privileges to patients," Richard Klein, former director of the FDA's Patient Liaison Program, says in an email. "It exempts investigational drug use from certain protections — namely criteria for informed consent under FDA, HHS (Health and Human Services) regulations and from IRB (investigational review board) review. The latter reviews informed consent to assure it adequately informs the patient of what they're getting into: What are the potential benefits, what are the potential dangers, as there may be serious toxicities associated with investigational agents, especially. It is the patient, the doctor and the company that have to consider when it's appropriate to try an investigational agent. There are a lot of variables that need to be considered and it is the company that holds the cards in deciding whether they are able and willing to provide the product."