President Trump Signs Right-to-Try Act

On Wednesday, May 30, 2018, Pres. Donald Trump signed the Right-to-Try Act, which allows terminally ill patients the ability to try drugs in preliminary testing but not-yet-approved by the Food and Drug Administration. The aim is to make it easier for those patients suffering from fatal illness who have exhausted all other resources to access drugs unapproved by the FDA, which may provide them some relief from their illnesses.

The Right-to-Try Act is also intended to create a more open and competitive market for drugs still seeking FDA approval, therefore, lowering the cost of the drugs since insurance companies do not cover them. Supporters of the legislation say it gives hope to those who are out of options, while opponents argue the legislation gives a false hope to many who are already in a vulnerable and fragile state.

While the intent is to allow patients to try drugs not otherwise available to them, many point out the FDA already allows patients access to these drugs through an expanded access program. This program allows terminally ill patients access to drugs not FDA approved, ensures the drug is administered correctly and certifies those receiving the medication are adequately informed. Additionally, the approval rate of patients completing the application requesting these drugs since 2006 is 99 percent.

Supporters of the Right-to-Try Act argue these numbers do not reflect the hundreds of patients neglected by the application process through incomplete applications and other factors. Now, the Right-to-Try Act takes the FDA out of the equation and leaves the power with patients and their physicians to work with drug companies directly to access unapproved drugs.

Despite its potential for success, the Right-to-Try Act comes with a significant downside. Since the only requirement for the drugs are that they have passed Phase I testing with the FDA stating they are safe on humans, there is no real understanding of possible side effects these drugs may have on patients. The uncertainty and margin of error around medications not approved by the FDA leave physicians concerned for the health and safety of the patients who choose to use them.