Tenth Amendment Center: Now In Effect: Louisiana Expands of Right to Try Act, Further Rejects Some FDA Restrictions

From Tenth Amendment Center

...from Tenth Amendment Center

BATON ROUGE, La. (Aug 1, 2017) – Today, a law goes into effect expanding Louisiana’s Right to Try law to include technology designed to help ALS patients with mobility. The new law sets the foundation to nullify in practice a Food and Drug Administration (FDA) rule that currently denies these patients’ access to this specific technology.

Rep. Julie Stokes (R-Kenner) and two cosponsors introduced House Bill 179 (HB179) in March. The legislation expands the Louisiana Right to Try law to include robotic technology that assists patients suffering from terminal degenerative muscular diseases with mobility.

The new law is specifically meant to allow ALS patients in the state to access EyeDrive technology that allows them to maneuver a wheelchair using eye movements. The technology is currently unavailable on the market because it is still in the FDA trial phase.

The Senate passed HB179 by a 38-0 vote. The House approved the measure by an 88-0 vote.

Former New Orleans Saints football player Steve Gleason inspired the legislation. He was diagnosed with Amyotrophic Lateral Sclerosis (ALS), commonly known as Lou Gehrig’s Disease, in 2011. This terminal illness produces progressive muscle weakness and eventually death. Gleason founded Team Gleason to help raise awareness of the disease and funds to fight it. As Gleason’s experience shows, technology can vastly improve the quality of life for ALS patients. He currently uses a machine that helps him breathe, and a feeding tube for nutrition. He communicates by typing with his eyes onto a tablet attached to his wheelchair. He can also use this same device to drive the wheelchair, pay bills, call/text/email for help, take selfies, play a video for his son, stream music and much more.

Currently, EyeDrive technology remains unavailable for most ALS patients due to FDA regulations. Passage of HB179 opens the door for all ALS patients in the state to bypass the FDA and access this amazing technology.

In 2015, the Louisiana legislature passed, and the governor signed,“Right to Try” legislation giving terminally ill patients access to medicines and treatments not yet given final approval for use by the FDA.

The Federal Food, Drug, and Cosmetic Act prohibits general access to experimental drugs. 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.

Louisiana Right to Try bypasses the FDA expanded access program and allows patients to obtain experimental drugs from manufacturers without first obtaining FDA approval. This procedure directly conflicts with the federal expanded access program and sets the stage to nullify it in practice. HB179 builds on that foundation and expands the law.

Although Right to Try only addresses one small aspect of FDA regulation, it provides a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.

Thirty-seven states currently have Right to Try in place. The rapid progress of this legislation and Louisiana’s efforts to improve its law shows that Americans from across the political spectrum intuitively understand that these FDA regulations are harmful and must be mitigated through state-level action.

Mike Maharrey
August 01, 2017 at 07:19AM