The Summit will be Chaired by Dr. Doris Taylor and will feature Legislative and Scientific Panels and other key members instrumental in HB 810, which passed this session. Leading scientists statewide will also participate.
The purpose of this Summit is to host an open forum and discuss Right to Try, Expanded Access and to draft comprehensive legislation for the 86th Legislative Session for these issues and Regenerative Medicine.
Texans for Cures fought to add language to protect patient’s safety during this last session, the 85th session of the Texas legislature ending May 29, 20017. With the help of Senators Kirk Watson, Charles Schwertner and Van Taylor, language was added to prohibit doctors from being compensated when administering drugs that had not completed the FDA approval process. Additionally, amended language stipulated a patient would not be charged when receiving an unproven drug. Texans for Cure’s Medical Advisory Committee (MAC) made these very important recommendations and the bill was passed with these patient protections.
This issue is not only topical for Texas, but has occupied other state legislatures and the FDA’s agendas as well. Right to Try is becoming the law of the land, state by state.
Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration, has posted on his blog that this September is when the FDA plans to introduce a comprehensive initiative aimed at making sure the nations regulatory processes are with the times, so as to insure safe and effective new technologies reaching patients in a timely fashion.
“To build upon such opportunities, FDA will soon unveil a comprehensive Innovation Initiative. It will be aimed at making sure our regulatory processes are modern and efficient, so that safe and effective new technologies can reach patients in a timely fashion. We need to make sure that our regulatory principles are efficient and informed by the most up to date science. We don’t want to present regulatory barriers to beneficial new medical innovations that add to the time, cost, and uncertainty of bringing these technologies forward if they don’t add to our understanding of the product’s safety and benefits.
For these reasons, as part of our public health mandate, we need to make sure that we’re taking a risk-based approach in everything we do. The 21st Century Cures Act gave FDA
many new authorities and resources to accomplish this mission. “Cures” provides FDA with tools aimed at modernizing our regulatory programs. The goal of many of these efforts is to make sure that we’re taking every appropriate step to facilitate access to safe and effective new innovation.”
It’s far from a settled topic though. Some fear the federal bills will be eliminating patient safeguards. The Hill, a top US political website, read by the White House and more lawmakers than any other site — vital for policy, politics and election campaigns, recently wrote their take on the matter on their blog:
“The federal bills were crafted to strengthen state laws, and, of special importance to proponents, to prevent the FDA from penalizing companies if bad outcomes result from the use of an unapproved drug. But the bills wouldn’t merely indemnify industry; they would entrench all the state law provisions, including those that are patient-hostile. Some states allow insurers to deny hospice or home healthcare benefits if a patient uses an unapproved drug. Some let them cancel coverage altogether. Equally alarming: Every law allows access to a product after just Phase 1 testing, in which a drug is tested on only a small number of people, thus producing virtually no information on how dying patients would tolerate it.”
BY LISA KEARNS AND NANCY NEVELOFF DUBLER, OPINION CONTRIBUTORS March 10, 2017 – 01:10 PM EST
Texans For Cures will be hosting the Summit which promises an open forum to discuss Right to Try, and Expanded Access and the future of patient safety in Texas. We need to draft comprehensive legislation that makes sense.