Experimental Stem Cell –Based Interventions in Texas: Good or bad “Charlie’s Law” is here

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The Texas state Legislature (source: http://www.capitol.state.tx.us/).

In the 2017 Texas legislative session, which ended on May 31, the state lawmakers passed a new bill to expand the state’s ‘Right to Try’ law — H.B. 810, also known as “Charlie’s Law.” The new law, which takes effect September 2017, allows patients who are chronically ill access to experimental stem cell-based interventions (SCBI) and permits clinics to charge patients for their ‘costs.’ While the law seems like a huge win for patients, it might also hurt the same people it is trying to help by reducing their protections. In contrast, the new law does place the state of Texas in a position to more readily regulate clinics providing experimental SCBIs, closing down those which are fraudulent.

In an article published in the Texas Heart Institute Journal, Dr. Iltis and I describe the risks associated with unregulated clinics offering unproven or experimental SCBI. The new Texas law would essentially circumvent the US Food and Drug Administration (FDA) and their Expanded Access Program (EAP), which regulates clinical trials and access to experimental therapies. It also bypasses many of the required ethical and informed consent rules required by the FDA. Instead, Dr. Iltis and I recommend an effort to find common ground between regulators and patients. As we describe in an 2015 paper, this compromise effort was effective in the 80s between HIV advocates and the FDA — resulting in the creation of the EAP as well as other initiatives to bring drugs to patients in need. Furthermore, complaints by patients and doctors regarding the lengthy process and work need to file an EAP application resulted in the FDA streamlining the process last summer.

While the FDA has closed some clinics that work on experimental SCBIs, they are finding it challenging to keep up with their proliferation. In 2016 they attempted to refine their oversight and held a public discussion to receive feedback on new rules. But the guidelines have yet to be changed and with the Trump administration’s anti-regulation stance, it is unlikely to be released in the near future. With the new law, Texas will have the ability to regulate clinics that do not follow the new regulations which includes obtaining Internal Review Board (IRB) approval of a protocol which has completed at least one stage of a clinical trial.

On October 4, the Baker Institute for Public Policy’s Center for Health and Biosciences and the Texas Heart Institute will convene a discussion with three key state legislators — Paul Bettencourt, Garnet Coleman and Tan Parker — and regenerative medicine scientist Doris A. Taylor. The panelists will discuss the legislative intent of the new law, what it will do for the state, and how we can protect patients.

This post was authored by Dr. Kirstin Matthews, fellow in Science and Technology Policy at Rice University’s Baker Institute for Public. For more research and publications from the Science and Technology Policy Program, visit www.science.bakerinstitute.org.

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