Bill allows terminally ill to use drugs awaiting FDA approval

By JAN LARSON McLAUGHLIN

BG Independent News

 

A bill has passed the Ohio House that would allow terminally ill patients to use drugs still in the trial period by the U.S. Food and Drug Administration.

State Rep. Tim Brown, R-Bowling Green, co-sponsored House Bill 290, which is also known as the “Right to Try” legislation. The bill passed the House after testimony was presented by people whose dying family members may have benefited by having access to the drugs, he said.

The law will allow Ohioans who are suffering from a terminal illness to have increased access to investigational drugs, biological products, or devices that have passed Phase I of an FDA clinical trial and will remain in ongoing trials.

The access must come with the recommendation of their treating physician and another physician.

“We’re not talking about something that’s not tested,” but rather drugs that are still in the lengthy trial periods with the FDA, Brown said earlier this week. “The drugs we’re talking about have already gone through the first rounds of FDA trials.”

If the Ohio Senate passes the bill, Ohio will join 24 other states that already allow access to such medications. Currently, Ohio citizens can travel to those other states to get the drugs, but cannot access them here in Ohio.

“This bill will expand treatment opportunities for Ohio’s terminally ill residents.  Far too often, patients who were previously unable to access potentially lifesaving medications in Ohio sought medical assistance in other states.  This bill will eliminate additional financial and emotional burdens and will provide options in Ohio for patients who desperately need it,” Brown said.

Currently, the FDA offers an expanded access program, which allows terminally ill individuals to access investigational medications. However there are only about 1,000 annual participants and the application process is burdensome.

This legislation does not require doctors to provide their patients with investigational drugs, but creates an opportunity not previously available to terminally ill patients and their physicians.

House Bill 290 now goes to the Ohio Senate for further consideration.