85th Texas Legislative Session – Protecting Patients and Responsible Research!

Right to Try

Background: In the 84th Legislative Session of 2015, the State of Texas passed, ”Right to Try” legislation with HB 21 by Kyle Kacal. The genesis of this legislation was formed by the Goldwater Institute in Arizona. They believe the FDA moves too slowly in approving drugs and therapies and terminally ill patients should be allowed to access drugs which have not completed the FDA clinical trial process.

This legislation has swept the country and has now passed and become law in 33 states with little opposition, but when it came to Texas, Texans for Cures fought to add language to protect patient’s safety. 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.

 

In this 85th session of the Texas legislature, three new bills were filed which jeopardized patient safety.

 

HB 661, HB 810 by Rep. Tan Parker and HB 3236 by Kyle Kacal would have dramatically changed the way patients could access unproven drugs and stem cell, “interventions” which have not been proven to be safe through FDA approved clinical trials.

HB 661

House Bill 661 would have allowed chronically diseased patients to access biologic drugs or devices which had only completed a FDA approved Phase 1 trial.

HB 810

House Bill 810 would have allowed chronically diseased patients to access an investigational stem cell,” intervention” without scientific oversight, or legal liability, or even completing a FDA Phase 1 approved clinical trial.

HB 3236

House Bill 3236 would have removed the provision added to HB 21 in the 84th session and would have required patients to pay for the costs of the manufactured drug.

 

Each of these three bills were unacceptable to Texans for Cures as filed, because they lacked scientific rigor and proper oversight, and therefore were ripe for fraud and abuse.

 

Legislative Timeline

 

March 2017

Texans for Cures (TFC) met with both of the bill’s authors and recommended patients should not have to pay for the costs of the drug. Also, we recommended for a patient to access an investigational drug, it should have completed at least a FDA approved Phase 2 trial. Neither member accepted these patient safety recommendations.

April 18, 2017

Chairman, David L. Bales, testified before the Texas House of Representatives Public Health Committee (see attached testimony).

April 18- May 10, 2017

TFC met with many House of Representatives offices and all 31 Senate members and provided letters of opposition from the following stakeholders: – International Society of Stem Cell Research – American for Cures, Don Reed – Dr. Doris Taylor, Texas Heart Institute – Dr. Willam Decker, Baylor College of Medicine – Dr. Mary Pat Moyer, Incell – Leigh Turner, Bioethicist, University of Minnesota Rice University, James Baker Institute ( Neutral document by Kirsten Matthews)

May 10, 2017

Chairman Bales testified before the Senate Health and Human Services Committee. However, this hearing was different for a couple of unexpected reasons. 1.) After being told the committee was not going to meet to consider HB 661 and HB 810,the Senate, ”suspended the rules” and announced the hearing would take place upon the Senate adjourning that day. 2.) The unfortunate part of this maneuver was we were unable to have Drs. Doris Taylor and William Decker provide their expert testimony on why Right to Try can be a very dangerous option for sick patients.

May 15, 2017

The Senate Health and Human Services Committee again met after suspending the rules to discuss an agreement between the Senate sponsor, Paul Bettancourt and Senators Charles Schwertner (Chairman of the Committee) and Van Taylor. Senators Schwertner and Van Taylor agreed to pass the bill out of Committee so long as each had the opportunity to add an amendment on the Senate Floor. After getting assurance from Sen. Bettancourt that the House and the author of the bill, Rep. Tan Parker, would concur on the bill as amended, members voted it out of committee 9-0. Shortly after, the amendments were successfully attached on the Floor of the Senate.

May 24, 2017

The House did not concur with the amended bill.

May 25, 2017

The Speaker of the House, Joe Straus, named the following House members to a conference committee on HB 810: Tan Parker, Drew Springer, Garnet Coleman, Charlie Geren and John Zerwas. The Lt. Governor, Dan Patrick named the following Senators to the conference committee: Van Taylor, Charles Schwertner, Jose Menendez, Charles Perry and Paul Bettancourt

May 26, 2017

The conference committee agrees to the Senate amendments and all members sign the committee report.

May 28, 2017

The Texas House of Representatives and Senate voted on the bill unanimously. Senator Van Taylor spoke at this time on, “Legislative Intent” regarding patient safety and it was recorded into the legislative journal.

May 29, 2017

Texas Legislature gavels out, Sine Die (Latin for, ”without a fixed day”) to meet again.

 

Final Analysis

The safeguards added with the amendments by Senator Charles Schwertner and Senator Van Taylor greatly improve patient protections and responsible research in Texas.

Sen. Schwertner’s amendment allows patients to sue physicians and drug manufacturers for adverse events as a result of a stem cell intervention.

Sen. Taylor’s amendment requires physicians to be affiliated with an IRB associated with an academic medical institution or hospital with at least 150 beds. And, they are required to report annually to the Texas Medical Board the results of all patient outcomes and collect and share all data with the medical board and the public.

The RTT members attempted to move the IRB oversight to the Health and Human Services commissioner, but the conferees in the Senate, led by Senators Taylor and Schwertner held strong and the final bill keeps the oversight with the TMB, where the language to protect patients is strong. Additionally, and we feel the most important issue, is patients will not be required to pay more than the normal costs for a manufactured drug or stem cell procedure. Senator Van Taylor’s, floor speech on “Legislative Intent” clearly defines the state’s mandate that physicians and manufacturers can not charge exorbitant fees to make a profit. If they do, they will be breaking the law.Considering the large amounts of money behind the efforts to pass legislation and the emotionally charged atmosphere, which would have made it easier to charge patients for unproven drugs and interventions (HB 3236, HB 661 and HB 3236), we feel very happy with the outcome.

Texans for Cures, with incredible support from many of you, helped quash HB 3236 (patient pay) and HB 661 (patient access to unproven biological drugs and devices). And, with the leadership of Senators Schwertner, Taylor, and Watson, and State Rep. Garnet Coleman, added patient protections which greatly improved HB 810. As originally written, this bill would have made Texas the true, “Wild West” and created a situation where unscrupulous stem cell operators could thrive.

Our team, will enjoy time at home and the satisfaction of winning a battle against opponents who we feel do not make patient’s safety and responsible research a priority and create an atmosphere where unscrupulous physicians can take financial advantage of patients in their most vulnerable mental state.

We fought the good fight and won!!!

Mary Scala

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