It should go without saying given the Texas Medical Board’s recent aggressive regulatory stance on the treatment of chronic pain, Texas physicians involved in the practice of testosterone and hormone replacement therapy should be made aware of a discussion by the Board at a recent Board meeting regarding a U.S. Food and Drug Association (FDA) safety announcement.
On January 31, 2014, the FDA issued a safety announcement alerting the public the FDA was investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA stated that although it had been monitoring risks related to testosterone products and decided to reassess this safety issue based on the recent publication of two separate studies suggesting an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.
To be clear, the FDA safety announcement stressed the FDA had not concluded FDA-approved testosterone products increased the risk of stroke, heart attack, or death or that patients should stop taking prescribed testosterone products. The Texas Medical Board’s discussions on these issues focused on relevant Board rules regarding standards for physicians practicing complementary and alternative medicine, including requirements of patient assessment, disclosure of expected outcomes, risks and benefits of treatment, a documented treatment plan with periodic review, adequate medical records, and therapeutic validity. The Board also discussed potential disciplinary issues with testosterone therapy which could arise with the “off-label” use of testosterone if the physician did not provide and obtain proper informed consent for off-label use or if the physician did not discuss the benefits weighed against possible risks of the therapy.
Because of the Board’s interest in this particular topic, Texas physicians in the field of testosterone or hormone replacement need to be hyper-vigilant in keeping proper consents and documentation, and keeping apprised of the relevant Board rules. The attorneys at the Leichter Law Firm have aided numerous Texas physicians to implement best practices. If the attention has shifted to you and you have an investigation or legal case pending before the Texas Medical Board, and want a knowledgeable administrative law attorney with experience working with the Board and its members, please call the attorneys at the Leichter Law Firm for a free consultation at 512-495-9995.