ANNAPOLIS, Md. (Nov. 4, 2015) – A Maryland bill scheduled for introduction in 2016 would set the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Sen. Bryan Simonaire (R-Pasadena) intends to file ‘Right to Try’ legislation for next year that would give additional options for patients facing life-threatening illnesses by tearing down federal roadblocks that have needlessly kept medicine out of the hands of the very sick.
“A lot of these drugs could save people’s lives and a lot of people don’t have time to wait,” Sen. Simonaire said in a Capital Gazette report about his anticipated legislation.
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.
“Americans shouldn’t have to ask the government for permission to try to save their own lives,” said Darcy Olsen, president of the Goldwater Institute. “They should be able to work with their doctors directly to decide what potentially life-saving treatments they are willing to try. This is exactly what Right To Try does.”
Although these type of bills only address one small aspect of FDA regulation, they provide 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.
“The Right to Try Act is a no-brainer,” said Mike Maharrey of the Tenth Amendment Center. “When someone is on their deathbed, the fact that FDA regulations would let them die rather than try, has got to be one of the most inhumane policies of the federal government. Every state should nullify the FDA like this.”
Maryland looks to join twenty-four other states that have approved Right to Try legislation. The momentum has built very quickly behind this idea, with most of these states passing these laws within the past year alone. This rapid progress shows that Americans from across the political spectrum intuitively understand that these FDA regulations are harmful and must be mitigated through state-level action.
The bill language is not available at the present time, but should be released to the public within the next several weeks.
