House passes ‘right-to-try’ — allowing the terminally ill to ask companies for experimental drugs outside of FDA’s purview

The House on Tuesday afternoon passed a Senate-ratified version of a bill, known as “right-to-try,” and President Donald Trump has indicated he will sign it — further proof that the Koch brothers-backed Goldwater Institute’s politicization of the US Food and Drug Administration (FDA) is just beginning.

Riding on the backs of terminally ill patients who have run out of options, Republicans pegged the bill as a last-ditch effort to “try anything.” At an earlier hearing, Rep. Morgan Griffith (R-VA) even went so far as to say that he would inject monkey urine into himself if “faced with one of these heart-rending situations.”

The bill’s backers, though, have yet to publicly disclose why the program is specifically necessary, or if there are examples of terminally ill patients who will gain access to investigational treatments because of “right-to-try” (companies are still allowed to reject requests) and would not have under FDA’s expanded access program.

The House’s passage of the Senate bill from last August — after a previous House bill passed but was not taken up by the Senate, and after a previous House version failed to pass — also follows the right-to-try movement’s spread across state legislatures. President Donald Trump has said he would sign the bill and Vice President Mike Pence said it was a priority for him.

But Rep. Frank Pallone (D-NJ) called the bill “dangerous,” “not necessary” and said it “needlessly exposes patients to unknown risks.” This bill is worse than what the House passed prior, Pallone said, noting a loophole in it that could expand the number of people than can use investigational drugs and are not terminally ill.

Public health experts, including FDA Commissioner Scott Gottlieb (though he has since said he backs the bill and that there’s leeway for implementation), had raised concerns on various versions of the bill, particularly as FDA already has its own version of “right-to-try,” known as expanded access, and the agency approves more than 99% of all expanded access requests.

Critics of the expanded access program have said it’s unnecessarily burdensome, though FDA has made clear that it can respond to an emergency request within 24 hours.

Regardless, with a right-to-try win under its belt, Goldwater now has its sights on easing the off-label promotion of medicines and further efforts to undermine the FDA.

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email for more information.

Image: Shutterstock

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