Texas House Bill HB661

Texas 2017 - 85th Regular

• Filed: 12/20/16

Caption

Relating to access to certain investigational drugs, biological products, and devices that are in clinical trials by patients with severe chronic diseases.

Impact

The legislation proposes a modification of current regulations regarding the utilization of investigational medications, aiming to streamline the path for eligible patients diagnosed with severe chronic ailments. While it seeks to provide a supplementary treatment avenue, the bill will also necessitate the designation of specific conditions as severe chronic diseases by the Texas Health and Human Services Commission. This action is critical as it will broaden the scope of options available to patients who may otherwise find themselves out of viable treatment choices.

Summary

House Bill 661, known as the 'Medical Freedom Act,' aims to expand access to investigational drugs, biological products, and devices for patients suffering from severe chronic diseases. The bill seeks to empower patients with the ability to pursue potentially life-altering treatments during their battle with debilitating conditions that do not permit the luxury of prolonged waiting times for regulatory approvals. By allowing these patients to explore options outside the traditional FDA approval route, the bill emphasizes the importance of individual choice in treatment decisions.

Sentiment

The sentiment surrounding HB 661 appears notably supportive, particularly from patients who advocate for the right to access innovative treatments. Medical professionals also indicate a positive outlook, arguing that patient-physician collaboration should be a central consideration in treatment decisions. However, some concerns or reservations could arise around possible risks associated with promoting investigational treatments that have not yet completed robust safety assessments, which may spark caution among regulatory bodies and patient safety advocates.

Contention

Notable points of contention may include the ethical implications of allowing access to unapproved medications and the responsibility of physicians in guiding patients through informed consent. Critics may argue about the potential risks of hastily deploying investigational drugs without comprehensive safety evaluations. The bill explicitly protects physicians from licensure repercussions based solely on their recommendations related to these drugs, which may invoke further debate about accountability in medical practice as it relates to patient protection.