The Republican Party has put language into its party platform championing “Right to Try” laws that set the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients.
Last week, the Republican Party platform committee met in Cleveland to discuss a wide variety of topics. They were tasked with figuring out exactly what should be in the party platform, in preparation for the actual nominating convention.
State Sen. Eric Brakey, a Maine delegate, offered an amendment to put language in favor of “Right to Try” into the party platform. Brakey introduced “Right to Try” legislation that was passed and signed into law in his home state earlier this year.
A Washington Free Beacon report elaborates on these developments:
The Republican Party platform committee adopted language on Monday supporting terminally ill patients’ access to drugs that have not been fully approved by the Food and Drug Administration.
“We commend those states that have passed Right to Try legislation, allowing terminally ill patients the right to try investigational medicines not yet approved by the FDA. We urge Congress to pass similar legislation, giving all Americans with terminal illnesses the right to try,” read the language adopted yesterday.
Before the amendment was officially adopted, delegates made impassioned pleas in favor of nullifying FDA regulations for terminal patients.
Juanita Cox, a Nevada delegate on the Platform Committee, told a heart-breaking antidote about a medical doctor she knows who tried to import experimental medicine for his MERSA-stricken daughter. Although he could easily cover the cost, the feds enforced their regulations and stopped the drugs from being imported from Japan. She died as a result.
“I just want to remind all the delegates that we are the party of liberty and freedom,” Michigan delegate Meshawn Maddock said in support of Sen. Brakey’s amendment. “And [we should do] anything that we can do that would limit the overreach of the FDA especially for people… who are already terminally ill.”
Although this may seem like a particular narrow instance of nullification, “Right to Try” laws introduce the idea into the political zeitgeist. This popular idea, now officially endorsed by the Republican Party, can lead to more substantial instances of state-level resistance down the line.
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.
The new laws create a process to bypass the FDA expanded access program and allow 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.
The new laws also feature protections for health care providers with prohibitions against revoking a license or issuing sanctions based on recommendation or issuance of such investigational treatments, as well as prohibiting lawsuits against physicians who comply with the law. Manufacturers of treatments will enjoy similar protections.
“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.”
More than two-dozen states 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.