Health Care
March 10, 2015
AUSTIN, TX – Today the Food and Drug Administration announced it has approved the first pediatric cancer drug due to the voucher program that became law under the Creating Hope Act. The drug, Unituxin, developed by United Therapeutics, designed to treat neuroblastoma, is only the third third drug to receive initial FDA approval for a pediatric cancer in the last 20 years. The Creating Hope Act was signed into law in 2011, and was sponsored by Representative Michael McCaul, Representative G.K. Butterfield, and Representative Chris Van Hollen.
Issues:Health Care
February 12, 2015
WASHINGTON, DC – Today, U.S. Representative Michael McCaul (R-TX) introduced H.R. 909, 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") process, by ensuring seriously ill patients have the right to know the compassionate use policies of pharmaceutical companies developing the most innovative treatments. He was joined by Representative G.K. Butterfield (D-NC), Rep. Michael Burgess (R-TX), Rep. Doris Matsui (D-CA), Representative Morgan Griffith (R-VA), and Representative Leonard Lance (R-NJ). The bill is named after Andrea Sloan, an Austin resident who died on New Year's Day 2014 after being denied access to a potentially lifesaving drugs to treat her seven-year battle with ovarian cancer.
Issues:Health Care
December 8, 2014
WASHINGTON, DC – 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.
Issues:Health Care
September 19, 2014
Friends say Andrea Sloan would have loved to attend a summit this weekend in Washington, D.C., that will focus on research for childhood cancer and expanded access to experimental drugs for all cancer patients.
Sloan, 45, passed away earlier this year after a fight to gain access to an experimental drug to treat her ovarian cancer through a process called compassionate use. She was eventually granted access to a different drug made by a different company, but by then, her cancer had progressed too far.
Issues:Health Care
July 31, 2014
Regeneron Pharmaceuticals Inc. and Sanofi SA are spending $67.5 million on a novel bet they hope will help them outflank Amgen Inc. in the race to get a new class of cholesterol drugs to the market.
The companies are paying the money to acquire a special voucher held by BioMarin Pharmaceuticals Inc. in a bid to hasten regulatory review of their drug alirocumab, one of an emerging group of medicines that lower cholesterol by targeting a gene known as PCSK9.
Issues:Health Care