De­spite po­lit­i­cal sup­port, state right-to-try bills show no takeup

Modern Healthcare - - NEWS - By Steven Ross John­son

Cal­i­for­nia Gov. Jerry Brown’s veto last week of a “right-to-try” bill dis­ap­pointed ad­vo­cates who want more state laws al­low­ing ter­mi­nally ill pa­tients ac­cess to ex­per­i­men­tal drugs.

Since the spring of 2014, 24 states have en­acted right-to-try laws that prom­ise to help dy­ing pa­tients cut through bu­reau­cratic red tape to get drugs not yet ap­proved by the Food and Drug Ad­min­is­tra­tion.

But a Mod­ern Health­care sur­vey found no ev­i­dence of any pa­tients re­ceiv­ing an ex­per­i­men­tal ther­apy as a re­sult of the new statutes, so far. A spokes­woman for the Louisiana State Med­i­cal So­ci­ety said the or­ga­ni­za­tion has re­ceived only two re­quests from pa­tients seek­ing in­for­ma­tion. Of­fi­cials in other states said they have not been con­tacted by physi­cians, who would by law be the ones ask­ing phar­ma­ceu­ti­cal com­pa­nies for the drugs. Also, no state has yet cre­ated the poli­cies or in­fras­truc­ture to help doc­tors nav­i­gate the right-to-try op­tion. States say they’re work­ing on it.

Some see the lack of ac­tion as proof that the laws are based more on pol­i­tics than help­ing pa­tients. The lib­er­tar­ian or­ga­ni­za­tion be­hind the cam­paign says this is only the be­gin­ning.

“There are nu­mer­ous peo­ple around the coun­try who are get­ting ready and pre­par­ing,” said Kurt Altman, di­rec­tor of na­tional af­fairs for the Phoenixbased Gold­wa­ter In­sti­tute. The in­sti- tute helped draft the right-to-try bills for state leg­is­la­tures, which were more open to the leg­is­la­tion than Congress.

Altman said the in­sti­tute is help­ing state reg­u­la­tors and med­i­cal boards in Ari­zona and a cou­ple of other states to “en­act any reg­u­la­tions that are re­quired to help fa­cil­i­tate (th­ese laws).”

The in­sti­tute’s goal is to push fed­eral leg­is­la­tion that would al­low dy­ing pa­tients to seek ex­per­i­men­tal drugs with­out reg­u­la­tory in­ter­fer­ence. Un­der right to try, ter­mi­nally ill pa­tients who have ex­hausted all other ap­proved treat­ment op­tions could re­quest a pre­scrip­tion for an ex­per­i­men­tal drug or med­i­cal de­vice that has passed Phase 1 of the FDA’s clin­i­cal trial process. Phar­ma­ceu­ti­cal com­pa­nies are not le­gally re­quired to pro­vide the drug and are not li­able if a drug causes harm or death. Few have come out in sup­port of the law.

Sascha Haver­field, vice pres­i­dent for sci­en­tific and reg­u­la­tory af­fairs at Phar­ma­ceu­ti­cal Re­search and Man­u­fac­tur­ers of Amer­ica, the trade group that rep­re­sents drug com­pa­nies, said he wor­ries the laws could neg­a­tively af­fect clin­i­cal tri­als. Pa­tients might be less will­ing to par­tic­i­pate be­cause they might be as­signed to a con­trol group that gets a placebo. Haver­field said com­pa­nies have re­sponded to the re­quest for ex­per­i­men­tal drugs by fa­cil­i­tat­ing aware­ness of ex­panded ac­cess pro­grams.

There’s also a sim­i­lar cur­rent FDA process called “com­pas­sion­ate use.”

Pro­po­nents of right to try say that FDA process, which could take months, was not help­ful to those with only a few months to live. The FDA ac­knowl­edged de­lays, and in Fe­bru­ary is­sued draft guid­ance for a sim­pler ap­pli­ca­tion form, cut­ting the amount of time it takes physi­cians to com­plete it from 100 hours to 45 min­utes.

Still, “ex­pe­dited on a fed­eral level is not ex­pe­dited when th­ese folks need it,” Altman said. Crit­ics say right-to-try laws im­pede the cur­rent fed­eral pro­gram.

“I think that po­lit­i­cally, (right to try) has been seen as a very pos­i­tive and proac­tive thing to sup­port,” said Ali­son Bateman-House, a post­doc­toral fel­low at New York Univer­sity Lan­gone Med­i­cal Cen­ter’s Divi­sion of Med­i­cal Ethics. But, she ar­gued, “There seems to be some sort of will­ful blind­ness to see­ing whether it works or not.”

None of the laws ad­dress what some say is a huge bar­rier to re­ceiv­ing drugs: cost.

Right-to-try laws do not re­quire health in­sur­ers to cover ex­per­i­men­tal treat­ment or any sub­se­quent care that may oc­cur as a re­sult of tak­ing an ex­per­i­men­tal drug.

In­sur­ers typ­i­cally do not cover the cost of ex­per­i­men­tal treat­ments, said Court­ney Jay, a spokes­woman for Amer­ica’s Health In­sur­ance Plans, who said the or­ga­ni­za­tion is still re­view­ing right-to-try laws to as­sess their po­ten­tial im­pact.

Haver­field said the so­lu­tion for ter­mi­nally ill pa­tients might be in the pro­posed 21st Cen­tury Cures Act, which passed in the House this sum­mer. That would re­quire com­pa­nies to pro­vide the FDA with more in­for­ma­tion on how they han­dle re­quests for in­ves­ti­ga­tional drugs through com­pas­sion­ate use.

GOP law­mak­ers have also in­tro­duced leg­is­la­tion that would pre­vent fed­eral ac­tion to block state right-to-try laws, but the out­come of that bill is un­cer­tain. So far, there has not been a push to cre­ate a fed­eral rightto-try law.

That’s why, Altman said, the in­sti­tute will con­tinue its cam­paign. He ex­pected Gov. Brown’s veto of a rightto-try bill will only em­bolden oth­ers to even­tu­ally get the bill passed.

“Our strat­egy is not go­ing to change,” Altman said.

IS­TOCK PHOTO

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