Right to Try vs. Expanded Access: What Patients Need to Know

When facing a life-threatening condition with no approved treatment options, patients and their families often find themselves navigating complex regulatory pathways in search of experimental therapies. Two distinct routes exist for accessing investigational treatments outside of clinical trials: the FDA’s long-established Expanded Access Program, also known as compassionate use, and the newer Right to Try pathway created by federal legislation in 2018. Understanding the key differences, advantages, and limitations of these options is crucial for patients confronting difficult treatment decisions. The FDA’s Expanded Access Program has evolved significantly since its formal establishment in the 1980s during the HIV/AIDS crisis. This pathway requires a multi-step process: the treating physician must contact the drug manufacturer to request the investigational treatment; if the company agrees, the physician then submits an application to the FDA; and finally, an Institutional Review Board (IRB) must approve the treatment plan. While this process may seem bureaucratically cumbersome, the FDA approves approximately 99% of expanded access requests it receives, often within days or even hours for emergency situations. The Right to Try Act, signed into law in May 2018, emerged from a movement arguing that terminally ill patients should have direct access to experimental treatments without government oversight. Under this pathway, eligible patients can work with their physicians to request investigational drugs directly from pharmaceutical companies, bypassing FDA review and significantly reducing paperwork requirements. However, similar to expanded access, drug manufacturers remain under no obligation to provide their investigational products. Eligibility criteria represent one significant difference between these...

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