“Right to Try Act”, coauthored by Rep. Canales, approved by Texas House to help dying patients finally have access to experimental medicines

by Legislative Media | Apr 23, 2015 | Politics

Featured, Rep. Terry Canales, D-Edinburg, and Rep. Senfronia Thompson, D-Houston, in the Chamber of the House of Representatives, and both co-authors of the potentially life-saving “The Right To Try Act”.

Photograph By HOUSE PHOTOGRAPHY

Texas is getting closer to becoming one of a handful of states to allow terminally ill patients, through their doctors, access to experimental but potentially life-saving drugs not yet on the market, but which have cleared initial review by the U.S. Food and Drug Administration. House Bill 21, whose primary author is Rep. Kyle Kacal, R-College Station, is based on a concept known as “Right to Try”, which advocates at the national level for many years have been championing as a humane and necessary option for gravely-ill patients who have no other legal last resort in Texas. HB 21 was approved by the House of Representatives on Wednesday, April 22. HB 21, coauthored by Rep. Terry Canales, D-Edinburg, would allow a dying person, with the consent of their physician, to receive promising new medication that has passed the first phase of the FDA’s rigorous review process, but which has not received final approval. “During this long process, people may die waiting for the FDA to approve potentially life-saving medicines,” said Canales. “HB 21 would help protect physicians and drug manufacturers from legal liability. But most importantly, it would provide a person another chance at life when there is no hope, which is what all of us would want for ourselves and our loved ones.” This legislation seeks to establish a remedy to this situation, he contended, explaining that the proposal “seeks to cut through the FDA’s red tape as the FDA is determining whether a drug is safe enough to bring to market.” Canales, who had also filed similar legislation, joined forces with Kacal to help successfully move the issue through the House of Representatives. Arizona voters on Tuesday, November 5, 2014, passed Proposition 303, a state ballot measure giving terminally ill patients the right to try investigational medicines that have passed the first phase of FDA approval but still may be years away from reaching pharmacy shelves. “Right to Try” is already law in Colorado, Louisiana, Michigan and Missouri, where it passed with overwhelming bipartisan support in all four states. Arizona is the first state to pass the law by voter initiative. A similar measure, Senate Bill 694 by Sen. Paul Bettencourt, R-Houston was approved by the Senate on Thursday, April 9, and is awaiting action in the House of Representatives. “In these fairly uncommon situations, time is a predator, that it is unconscionable that government is standing in the way of a potential cure,” Bettencourt said. In explaining the intent of the “Right To Try Act”, Canales outlined the key processes required by the FDA before a new drug is approved. “There are four phases in the drug review process by the FDA, which can take as longer than a decade to complete, far too long for critically-ill people who have not been helped by available medications and treatments,” the South Texas lawmaker said. Phase I alone, on average takes almost two years to complete. “Right to Try” has bipartisan political support, including from the Goldwater Institute of Phoenix, Arizona, which was founded in 1988 with the blessings of the late Sen. Barry Goldwater, a national conservative leader and Republican presidential nominee in 1964. He served in the U.S. Senate for 30 years until his retirement in 1987. According to the Goldwater Institute, even a program by the FDA to allow a critically-ill patient, with the consent of his/her physician, to use experimental drugs takes too long. The FDA, whose extensive duties include ensuring that medicine is safe and effective for human use, is a huge federal agency with almost 15,000 employees and a $14 billion operating budget. Such a massive government organization makes it difficult to overcome overwhelming bureaucratic red tape and related delays. As a result, the Goldwater Institute contends that such bureaucratic impediments violate an individual’s fundamental right to try to save his own life. Unfortunately, the federal government has shown little interest in reforming the FDA as bills to reform the process for terminal patients have been introduced, but have never received a vote in Congress. State legislators, however, have the opportunity to protect their citizens’ right to try investigational medications by enacting Right to Try measures. These measures would ensure the right to protect one’s life by returning medical decisions where they belong – to patients and doctors. “Terminally ill people don’t have time to wait for new drugs to make their way through the decade-long approval process. Prop 303 lets patients work directly with their doctors to access promising investigational medicines now,” said Darcy Olsen, president of the Goldwater Institute. The FDA has a process that allows people to seek permission to access investigational medicines. This “Compassionate Use” process takes hundreds of hours of paperwork and time to navigate. While many people ultimately receive FDA permission, there are dozens of documented cases of people dying while waiting on their approval. “Americans shouldn’t have to ask the government for permission to try to save their own lives,” said Olsen. “They should be able to work with their doctors directly to decide what potential treatments they are willing to try.”

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