Idaho OKs Experimental Treatment for Terminal Patients

Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....

By Paul Shukovsky

March 28 — Idaho Gov. Butch Otter (R) signed into law a bill March 23 that lets practitioners treat terminally ill patients with investigational drugs or devices not yet approved by the U.S. FDA.

With Otter's signature, Idaho becomes the 25th state to enact a so-called right-to-try bill, according the Goldwater Institute—a think tank supporting “constitutionally limited government,” which has been circulating model legislation around the country.

Right-to-try bills in Georgia and Maine are awaiting gubernatorial signatures, Goldwater Senior Policy Advisor Starlee Coleman told Bloomberg BNA March 28.

The Idaho bill tracks closely with the Goldwater model legislation in removing state legal impediments to use of investigational products.

“It is the intent of the legislature to protect physicians and other parties from civil, criminal or professional liability” relating to right-to-try treatments, according to the Idaho bill.

The bill defines an eligible investigational drug, biological product or device as one that “has successfully completed phase 1 of a clinical trial but has not yet been approved for general use by the United States Food and Drug Administration and remains under investigation” in a FDA-approved clinical trial.

The bill does not compel a manufacturer, hospital or provider to offer an investigational product or require a health plan to pay for it.

‘Unfortunate Sign of Polarization.'

The bill also prohibits state licensing boards or disciplinary bodies from taking action against a provider's license based on a recommendation to an eligible patient regarding access to or treatment with an investigational product. And the new law explicitly declares that it creates no private cause of action against a manufacturer or provider who “has exercised reasonable care” in providing such a product in good-faith compliance with the law.

Opponents to right-to-try bills in some states have cited revisions to the FDA's compassionate-use program for accessing investigational drugs as a reason to hold off on passage of such bills. Before a right-to-try bill unanimously passed the Oregon Legislature last July, lawmakers heard testimony from a medical ethicist who said the revised FDA program should be given time to prove itself before passage of a right-to-try bill . California Gov. Jerry Brown (D) vetoed a right-to-try bill in October saying he wants to give the FDA program a chance to work .

The Goldwater Institute's Coleman said the FDA's revised compassionate-use application “is still not available and they can't explain why. That’s why we say people shouldn't have to fill out an application to the government to save their life.”

Coleman noted that a federal right-to-try bill has yet to emerge from Congress .

“Maybe it’s just an unfortunate sign of the polarization in Congress,” she said. “At the state level, the bills are extremely bipartisan. In almost half the states where the bill has been introduced, it’s been introduced by Democrats and not a Republican. In most states where it passes, it passes unanimously.”

Bipartisan Support in Idaho

The Idaho bill, HB 481, was sponsored by a Democrat and passed the Republican-majority Legislature with only a single no vote in each chamber.

According to the Goldwater Institute, right-to-try laws previously have been enacted in: Alabama, Arizona, Arkansas, Colorado, Florida, Illinois, Indiana, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, North Carolina, North Dakota, Oklahoma, Oregon, South Dakota, Tennessee, Texas, Utah, Virginia and Wyoming.

To contact the reporter on this story: Paul Shukovsky in Seattle at pshukovsky@bna.com

To contact the editor responsible for this story: Kendra Casey Plank at kcasey@bna.com