Right-To-Try Laws and Access to Experimental Drugs

Treatments under the Right To Try Act often have not received full FDA approval. The Act creates legal ways for patients to gain access to these investigational drugs. Patients can work with manufacturers and doctors to access these treatments. Consulting with a healthcare attorney helps you with an access request and understand your right to try these experimental drugs. They can explore your options and help you maximize your treatment chance.

History of Right-To-Try Laws

Colorado was the first state to pass a right-to-try law in 2014. Many other states followed suit. The movement began with patients and patient advocates getting frustrated by the lack of access to experimental drugs with potential life saving qualities. Patients have to wait for the Food and Drug Administration (FDA) to approve medications. The drug approval process often involves three phases of testing, which may take years before the drugs become available.

What Are Right-To-Try Laws?

President Trump signed the Right to Try Act into Law in May 2018. This federal law gives eligible patients permission to access experimental drugs, biologics, and other medical products. It allows doctors and drug companies to give experimental treatments to eligible patients without the threat of liability. Pharmaceutical companies are also protected from legal consequences, whether they provide the treatment or refuse to give it.

Right-to-try laws provide legal ways for patients with life-threatening conditions to gain access to experimental drugs and investigational products. Often, they do so when conventional treatments fail and they are facing limited treatment options. These laws allow patients to use medicines or treatments not yet fully approved by the U.S. Federal Drug Administration (FDA). This means that the agency has not determined the safety, effectiveness, or potential side effects of these drugs.

Under this law, the patient and treating physician work with a drug manufacturing company to obtain the drug. For patients to be eligible under the Right to Try Act (.pdf download), there are certain criteria that they have to meet:

• The patient has a life-threatening condition or disease
• The patient used all conventional treatment options and cannot join a clinical trial for the experimental drug at their local medical center
• The patient understands the risks involved and provides written consent to their doctor about the use of the investigational (experimental) drug

Meeting these requirements only grants legal access to the experimental drug. Manufacturers are not required to give you their experimental medicines. Moreover, the FDA cannot compel these manufacturers to give you access to these experimental drugs.

State Laws

Most states have right-to-try laws. There are key differences between the state versions and the federal law. For instance, California’s law only covers those patients that have immediately life‑threatening condition. In contrast, federal law covers a broader “terminally ill patients” category of eligibility.

A major similarity between state and federal laws is that there is no guarantee of access to drugs. There are no mandates that compel drug manufacturers to give the drugs to patients. It is strictly based on the manufacturer’s decision. Often, manufacturers are not willing to participate.

There are many reasons why drug companies would not want to provide experimental drugs to patients. These laws cover unapproved drugs in the FDA’s Phase I drug development, which means the drug is only in the phase where they figured it might be safe for humans. 

Patients can experience serious adverse events, which manufacturers often discover in the later phases of testing. If patients experience side effects, it can affect the chances of the drug getting approved later on.

How Does the Federal “Right To Try “Act Differs From FDA’s Expanded Access?

Two related laws govern access to investigational new drugs: the Right to Try Act and the FDA’s Expanded Access Program. These laws are essential for patients seeking treatment options. Both laws serve the same populations, but a critical distinction lies in the regulatory review of the FDA.

The FDA’s Expanded Access Program, known as “compassionate use,” has operated for over 30 years. The Right to Try Act was passed in 2018. The critical distinction between these laws is the FDA’s regulatory oversight. The laws differ greatly due to required FDA review and approval by the institutional review board (IRB). The Right to Try Act completely bypasses these regulatory safeguards.

In addition, Expanded Access requires a two-page form. A physician submits this form, which the institutional review board will examine before deciding whether or not to approve it. In contrast, the Right to Try Act allows physicians to directly request investigational drugs from manufacturers. 

Studies show that many drug manufacturers prefer the FDA Expanded Access program. A Government Accountability Office review found a key problem. Over half of drug companies require additional steps before approving right-to-try requests and would ask for FDA or IRB review. This suggests that drug manufacturers value regulatory oversight for patient safety.

Did COVID-19 Impact Right-To-Try Usage?

Many people expected COVID-19 to increase the number of patients who would use right-to-try laws and a rise in patient access to experimental vaccines and other treatments. However, documented cases using the Right to Try Act during this public health emergency showed that drug companies preferred other alternatives.

NeuroRx provided one of the few instances of a company willing to expand access to drugs it was still testing. In January 2022, it announced that it was expanding its Expanded Access and right-to-try programs for Aviptadil. It was made available to certain patients who suffered from COVID-19 Respiratory Failure and have used all conventional therapies.

Legal Risks and Liability Considerations

The federal Right to Try Act provides broad immunity protections. It shields doctors, manufacturers, sponsors, and dispensers from liability. An exception to this only applies in gross negligence cases or willful misconduct, but state laws could create a complex legal landscape. Healthcare providers should consider malpractice standards when giving experimental treatments. This is important for medications and treatments that are outside FDA oversight.

According to a clinical analysis, right-to-try laws face particular challenges. These challenges often arise during informed consent procedures. Clinical trials have federal regulations and standard consent protocols. Right-to-try does not have uniform FDA requirements and IRB oversight. The absence of these standard disclosures could cause a potential legal dilemma. This challenge could occur if patients suffer adverse outcomes or claim inadequate disclosure of risks.

Disputes with insurance coverage often arise when patients participate in experimental treatments. This creates significant financial liability for families. Patients should consult with healthcare attorneys before pursuing experimental treatments. These treatments are expensive and may not be covered by insurance.

Considering Right-To-Try Treatments? Get Legal Guidance From a Healthcare Attorney

Right-to-try laws can be confusing and gaining access to an experimental drug can be overwhelming. Seeking legal advice from a healthcare attorney may make things a little less difficult. They can help you understand your rights in both federal and state laws. A healthcare attorney can also assist you in learning more about accessing investigational treatments and protect your patient rights if legal issues arise.