Tenth Amendment Center: Signed as Law: Mississippi Expands Right to Try, Rejects Some FDA Restrictions
JACKSON, Miss. (June 26, 2020) – Yesterday, Mississippi Gov. Tate Reeves signed a bill into law that expands the sate’s “Right to Try” law. The new provisions will increase the number of patients eligible for experimental treatments and allow patients to access stem cell treatments not yet given final approval by the FDA, nullifying some agency regulations in effect.
A Republican and two Democrats sponsored Senate Bill 2830 (SB2830). Mississippi enacted Right to Try in 2015 and expanded its provisions the following year. SB2830 expands it further, making patients with “traumatic injuries” eligible for experimental treatments under the law. It also adds adult autologous mesenchymal stem cells to the list of experimental treatments covered under the act.
The Senate passed SB2830 50-0 back in March. The House approved the measure 114-0 on June 12. With Gov. Reeves’ signature, the new law went into immediate effect.
BUILDING AGAINST FDA RESTRICTIONS
SB2830 builds on and expands Mississippi’s Right to Try Act, authorizing terminally ill patients to access experimental treatments not yet approved by the FDA.
The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs and treatments. However, under the expanded access provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb, patients with serious or immediately life-threatening diseases may access experimental drugs after receiving express FDA approval. RIght to Try allows terminally ill patients to bypass the expanded access provision and obtain experimental drugs from manufacturers without first obtaining FDA approval.
Congress passed a federal Right to Try law in 2018 after 40 states enacted laws allowing terminally ill patients to effectively bypass the FDA and try experimental treatments without federal permission.
SB2830 goes a step further, specifically authorizing stem cell treatments in Mississippi without regard to FDA regulations and expanding access beyond patients with terminal illnesses and debilitating disabilities to include those with traumatic injuries.
This expansion of Right to Try demonstrates an important strategic point. Passing bills that take a step forward sets the stage, even if they are limited in scope. Opening the door clears the way for additional steps. You can’t take the second step before you take the first.
Mike Maharrey
June 26, 2020 at 03:28PM
