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 news@raps.org for more in­for­ma­tion.

Im­age: Shut­ter­stock

Author

Zachary Brennan

managing editor, RAPS

Hal Barron, GSK

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And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Until now.

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