COLUMBUS, Ohio (Dec. 19, 2016) – Last week, the Ohio Senate unanimously approved a bill that sets the foundation to nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally ill patients. The legislation now heads to Gov. John Kasich’s desk for his consideration.

Rep. Robert Sprague (R-Findlay) and Rep. Marlene Anielski (R-Walton Hills) introduced House Bill 290 (HB290) back in January. The legislation would enable terminally ill patients to access medications and treatments not yet given final approval for use by the FDA.

The House passed HB290 96-1 in February and the Senate approved the measure 32-0 on Dec. 6. Gov. Kasich will have 10 days from the date of transmittal to his office to sign or veto the bill. If he doesn’t act, it will become law without his signature.

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.

HB290 creates a process to bypass 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.

According to The Courier, only 5 percent of Ohioans get approval to enter clinical trials.

“Breast cancer is just one example where the bill could have an impact.There are 22 pioneering breast cancer treatments waiting for the FDA’s final approval. But while some of them are already available and saving lives in Europe, only about 1,000 people in the U.S. receive help each year. Others die while waiting for approval.”

The legislation includes provisions shielding manufactures of experimental drugs from liability.

Except for actions or omissions constituting willful or wanton misconduct, a manufacturer or terminal distributor that provides or distributes an investigational drug, product, or device pursuant to this section and section 4731.97 of the Revised Code is not liable for or subject to damages in any civil action or prosecution in any criminal proceeding for actions or omissions related to providing or distributing the investigational drug, product, or device.

If Kasich signs HB290 into law, Ohio will become the 33rd with a Right to Try law on the books. Although these laws 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.

“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.”

The Right to Try Act is a no-brainer. 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 take action to nullify the FDA like this.

Mike Maharrey

The 10th Amendment

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