HB 2246

This bill authorizes a doctor to perform stem cell therapy that is not approved by the United States f ood and d rug A dministration ( " FDA "" ) if the therapy is used for treatment or a procedure within the doctor 's scope of practice and is related to orthopedics, wound care, or pain management. As used in this bill ""s tem cell therapy "" m eans a treatment involving the use of afterbirth placental perinatal stem cells or human cells, tissues, or cellular or tissue-based products, which complies with the regulatory requirements provided in this section, but it explicitly excludes human cells or tissues that were derived from a fetus or an embryo after an abortion. STANDARDS In order t o ensure the highest standard for the retrieval, manufacture, storage, and use of stem cells, this bill requires that such cells be (i) r etrieved, manufactured, and stored in a facility registered and regulated by the FDA ; (ii) r etrieved, manufactured, and stored in a facility certified or accredited by the National Marrow Donor Program, the World Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, or the American Association of Tissue Banks ; and (iii) v erifie d to contain viable or live cells using a post-thaw analysis report, which must be sent to the doctor prior to use. FACILITY CERTIFICATION OR ACCREDITATION This bill prohibits a doctor from obtaining stem cells for therapy from a facility unless the facility maintains valid certification or accreditation. Any contract for obtaining such cells require s the facility to provide the doctor with its name, address, accrediting organization, dates of the accreditation, and an y contracted limitations. The facility must also notify the doctor within 30 days of any change in accreditation status. When performing a procedure, the doctor must use products from facilit ies adhering to current good manufacturing practices pursuant to the federal Food, Drug, and Cosmetic Act . NOTICE IN ADVERTISEMENT This bill requires a doctor using stem cell therapy to include a notice in any form of advertisement stating that the doctor performs therapies not yet approved by the FDA . The notice must encoura ge consultation with a primary care provider, be clearly legible, and be in a type size no smaller than the largest type size used in the advertisement. CONSENT This bill requires a doctor to obtain a signed consent form from the patient or the patient ' s representative. The form must contain (i) t he nat ure of the proposed treatment ; (ii) a statement that the therapy has not been approved by the FDA ; (iii) t he anticipated results of the treatment ; and (iv) t he recognized risks, complications, anticipated benefits, and possible alternative treatments, including nontreatment. EXEMPTIONS T his bill does not apply to doctors who ha ve obtained FDA approval for an investigational new drug or device for the use of human cells or tissues. It also does not apply to a doctor performing therapy under a contract for institutions accredited by the Foundation for the Accreditation of Cellular Therapy, the Blood and Marrow Transplant Clinical Trials Network, the Association for the Advancement of Blood and Biotherapies, or an entity determined by the depart ment to have expertise in stem cell therapy. VIOLATIONS This bill provides that a violation may subject the doctor to disciplinary action by the doctor's respective board. Additionally, a doctor commits a Class E felony if the doctor intentionally perform s or participate s in (i) t reatment s using human cells or tissues derived from a fetus or embryo after an abortion ; or (ii) t he sale, manufacture, or distribution of computer products created using human cells, tissues, or cellular or tissue-based products. A Class E felony offense is punishable by a term of i mprisonment of n o less than one year nor more than six years and a potential fine not to exceed $3, 000. RULEMAKING This bill authorizes the board of medical examiners and the board of osteopathic examination to promulgate rules to effectuate th is bill."