{"database": "press", "table": "releases", "rows": [["https://mccaul.house.gov/media-center/press-releases/mccaul-introduces-bill-to-improve-access-to-potentially-lifesaving-drugs", "McCaul Introduces Bill to Improve Access to Potentially Lifesaving Drugs for Sick Patients", "2014-12-08", "2014", "2014-12", "Republican", "House", "TX", "Michael McCaul", "M001157", "mccaul.house.gov", null, null, "legacy", "McCaul Introduces Bill to Improve Access to Potentially Lifesaving Drugs for Sick PatientsThe Andrea Sloan CURE Act will reform Compassionate Use laws\n\t\t\t\tWASHINGTON, DC Today, U.S. Representative Michael McCaul (R-TX) introducedH.R. 5805, theAndrea 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.\n\t\t\t\tThe 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 Sloanand 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.\n\t\t\t\tUpon introduction of the bill, RepresentativeMcCaulsaid, 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. TheAndrea Sloan CURE Actwill give patients and doctors up front information about how to access experimental treatments and provide drug companies more certainty about the compassionate use program.\n\t\t\t\tTheAndrea Sloan CURE Actwould:\n\t\t\t\t\nEnsure that pharmaceutical companies have publicly accessible compassionate use policies for drugs treating serious or life-threatening conditions;\n\t\t\t\t\t\nDignify patients with an explanation if their request for compassionate request is denied;\n\t\t\t\t\tRequire the Government Accountability Office to conduct a thorough analysis of the current compassionate use program, including the number of patient denials and reasons why companies reject requests;\n\t\t\t\t\tEstablish a compassionate use Task Force to provide recommendations to further improve the compassionate use program; and\n\t\t\t\t\t\nRequire the FDA to finalize its May 2013 draft compassionate use guidance for industry and clarify how it interprets and uses adverse drug event data in compassionate use cases.\n\t\t\t\t\nMcCaul has been a leader on compassionate use since the passing of Andrea Sloan early this year. He released awhite paperoncompassionate use in October shortly after the annual Childhood Cancer Summit that he hosted in Washington where he brought together leaders from the pharmaceutical industry and government to discuss patient access to experimental drugs. TheAndrea Sloan CURE Actwill be introduced again early next Congress, when Representative McCaul hopes to advance this legislation through the21stCentury Cures Initiative.A section-by section of the bill can be found here.\n\t\t\t\t###", 1, "2026-03-30T12:14:52Z", "2026-03-30T12:14:52Z"]], "columns": ["url", "title", "date", "year", "month", "party", "chamber", "state", "member_name", "bioguide_id", "domain", "scraper", "source", "date_source", "text", "has_text", "collected_at", "updated_at"], "primary_keys": ["url"], "primary_key_values": ["https://mccaul.house.gov/media-center/press-releases/mccaul-introduces-bill-to-improve-access-to-potentially-lifesaving-drugs"], "units": {}, "query_ms": 0.8329018019139767, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": "https://github.com/dwillis/congress-press/blob/main/LICENSE"}