McCaul Introduces Bill to Improve Access to Potentially Lifesaving Drugs for Sick Patients

Press Release

Today, U.S. Representative Michael McCaul (R-TX) introduced H.R. 5805, the Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act, which would make important reforms to the Food and Drug Administration's (FDA) expanded access ("compassionate use") program, by ensuring seriously ill patients have the right to know the compassionate use policies of pharmaceutical companies. The bill is named after Andrea Sloan, an Austin resident who died on New Year's Day after being denied access to a potentially lifesaving drugs to treat her seven-year battle with ovarian cancer.

The FDA permits patients, on a case-by-case basis, to access treatments still in the development process and outside of the clinical trial setting when certain criteria are met. Recent high profile cases, such as Andrea Sloan and seven-year-old pediatric cancer patient Josh Hardy's requests for access to experimental drugs, and the recent passage of "Right to Try" laws in several states, cry out for a federal response to reform and enhance the compassionate use program.

Upon introduction of the bill, Representative McCaul said, "Across the United States, patients with life-threatening conditions are desperate for treatments that hold the potential to save and prolong their lives. In some extreme cases, experimental drugs or devices may be a patient's only hope when FDA-approved treatments are not available and when patients are unable to enroll in a clinical trial. The Andrea Sloan CURE Act will give patients and doctors up front information about how to access experimental treatments and provide drug companies more certainty about the compassionate use program."

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