Earlier this year, President Trump signed the Right to Try Act into law. The stated goal of the law is to expand access to experimental medications particularly in those states like New York and New Jersey that don’t already have a similar state law. The law gives terminally ill patients the ability to obtain experimental drugs directly from pharmaceutical companies, but it has many limitations and practical obstacles may make the process more difficult. However, there is hope for patients armed with knowledge about their rights and options.
The advantages and disadvantages of the law include the following:
- The experimental medications that this Act makes available are those that have passed “phase 1” testing but have not yet passed FDA “phase 2” testing and are in the clinical trials stage. The purpose of “phase 1” testing is to determine the safety and dosage that can be taken by patients; the efficacy and side effects of the drug have not yet been determined. Therefore, patients may or may not see results from taking the drug, and using the drug may involve unknown health risks.
- Pharmaceutical companies are not required to allow a patient to access the experimental drug. The decision is in their discretion and they cannot be held liable for not providing the drug to a patient. However, pharmaceutical companies and doctors are incentivized to allow access to the experimental drug because the Act protects them against liability and negative consequences of patients who have bad side effects from the drug. Under the Act, patients cannot sue the sponsor, manufacturer, dispenser or prescriber of the medication unless there is willful misconduct or gross negligence. If patients have bad results from taking the drug, those cannot be used against the pharmaceutical company in the next stage of approving the drug before the FDA.
- The law doesn’t provide a way to pay for the medication or regulate the cost of it. This varies from some state laws which actually forbid companies from charging for the right to try drugs. Unfortunately, the law’s failure to help patients afford these drugs will seriously limit patient usage.
- Practically speaking, if a pharmaceutical company does choose to charge for the drug, patients may be able to negotiate the cost of the drug with the company. Most pharmaceutical companies have a “Compassionate Use” department which handles such situations.
- In addition to the cost of the drug itself, there are usually medical charges for the cost of administering certain drugs (e.g., visiting the doctor or hospital in order to have a chemotherapy drug administered). The likelihood of insurance paying for these costs is low since they are tied to an experimental drug being administered outside of the context of a formal clinical trial and there is nothing in the law requiring insurance companies to pay. Therefore, patients will likely be responsible for covering these expenses out-of-pocket. The law does not set out any procedures or guidelines for doctors or hospitals with respect to administering these drugs, so some are instituting their own rules. For example, some hospitals in New York and New Jersey have developed procedures around “right to try” access and will require a contract between the patient and the hospital to allow for the administration of the drug and payment of the cost.
The federal law leaves parties (patients, doctors, pharmaceutical companies, etc.) to handle the process themselves. Unfortunately, it is often hard for patients and their families to negotiate these matters given the emotions and stress that can result from terminal illness and the time-sensitive nature of accessing drugs. As a result, they may find it helpful to have an advocate who can ensure that the manufacturer, hospital and doctor are following federal and state laws as well as their own organization guidelines for when patient access is given and how payment is handled.
If you need assistance with understanding and managing these rules and regulations, contact us for a consultation.