Lawmakers Push for Right-to-Try Bills Across the Nation

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“Right-to-Try” bills are sweeping the nation in 2015,  as 24 states have already granted patients with life-threatening illnesses the right to seek out experimental treatments not yet approved by the U.S. Food and Drug Administration.

In October, California was on the cusp of adopting such a Right-to-Try bill. Proponents of the bill, titled Assembly Bill 159, expected Governor Jerry Brown to quickly sign it in light of Brown’s recent signature on a law allowing terminally ill patients to voluntarily end their lives with a doctor’s assistance. Nevertheless, Brown vetoed the bill, citing the FDA’s compassionate use program as a viable alternative for patients to gain access to experimental therapies.

As evidenced in California, these Right-to-Try bills are still controversial. Even as terminally ill patients gain more rights to choose when and how they die, they continue to have limited choices in their healthcare while they are alive.

Right-to-Try proponents believe that hospitals and doctors are concerned about providing experimental drugs to desperate patients because they fear legal liability. Healthcare providers, they claim, simply don’t want to take on the risk of allowing patients access to an unapproved drug in case the drug has unintended side effects. They argue that these drugs have been proven safe for use by humans and should be available to dying patients even though they haven’t gone through every stage of the FDA’s stringent, and expensive, approval process.

It can take 10 years or more for a drug to go through full FDA approval, and the process costs drug companies an average of $1.2 billion per drug.

To gain FDA approval, a drug needs to go through three stages of clinical trials. During the first phase, the drug is given to a small number of patients to determine whether it is safe for use in humans, and at what dose. The second and third stages involve testing the safety and effectiveness of the drug on larger patient groups and monitoring for toxicities and side effects. Even after a drug is approved for sale, it undergoes after-market testing to further monitor its long-term effects.

Right-to-Try bills such as the one proposed in California would not give patients the right to take any untested drug they wish. Instead, the bills give patients access to drugs that have completed phase one trials and are undergoing further testing.

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Many drugs that advance through phase-one clinical trials never make it past stage two, but some do. Right-to-try laws give patients access to these potentially life-saving medications that are in legal limbo with the FDA.

Right now, patients living in states that don’t have Right-to-Try laws can petition the FDA for unapproved treatments under the agency’s compassionate use policy. However, the process is long and involved. The FDA requires proof that a patient is terminally ill along with documentation from the patient’s doctor showing that standard therapy has not been effective. By the time patients get special approval, months usually have gone by. Further, drug companies are under no obligation to comply with the patient’s request. (Nor are they required to release drugs to patients in “Right-to-Try” states.)

Critics of Right-to-Try legislation argue that the law gives patients access to drugs that are unlikely to help them and may, in fact, make their condition or quality of life far worse. However, many patients and families who don’t have 10 years to wait for FDA approval believe that the benefits of these treatments outweigh that risk.