Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
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.
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.”
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 email@example.com
To contact the editor responsible for this story: Kendra Casey Plank at firstname.lastname@example.org
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)