Clash over drugs

De­fense bill would al­low com­bat troops to use un­ap­proved pills, de­vices

The Washington Post - - FRONT PAGE - BY LAU­RIE MCGIN­LEY lau­rie.mcgin­ley@wash­ More at wash­ing­ton­ news/ to-your-health

The FDA is bat­tling a Pen­tagon pro­posal to use emer­gency drugs and de­vices that the FDA hasn’t ap­proved.

Should the Pen­tagon be al­lowed to au­tho­rize the use of un­ap­proved drugs and med­i­cal de­vices on an emer­gency ba­sis for com­bat sol­diers?

That ques­tion has sparked a fu­ri­ous bat­tle this week among some of Wash­ing­ton’s big­gest power play­ers, with the De­fense De­part­ment and its con­gres­sional ad­vo­cates on one side and the Food and Drug Ad­min­is­tra­tion and the health com­mit­tees on the other.

The Capi­tol Hill clash was set off by a pro­vi­sion in the an­nual de­fense au­tho­riza­tion bill that would al­low the de­fense sec­re­tary to au­tho­rize the emer­gency use of drugs and de­vices that have not been ap­proved by the Food and Drug Ad­min­is­tra­tion. The per­mis­sion would ap­ply to mil­i­tary per­son­nel who are out­side the United States.

The FDA has the sole au­thor­ity to make de­ci­sions on med­i­cal prod­ucts, in­clud­ing dur­ing an emer­gency. The De­fense De­part­ment can ask the FDA to grant an emer­gency au­tho­riza­tion to use un­ap­proved drugs and de­vices if there is a threat of a chem­i­cal, bi­o­log­i­cal, ra­di­o­log­i­cal or nu­clear agent.

The FDA and lead­ers of con­gres­sional health com­mit­tees say that giv­ing the Pen­tagon the au­thor­ity to de­cide whether to use un­ap­proved drugs and de­vices could ex­pose sol­diers to dan­ger­ous prod­ucts. Mem­bers of the de­fense pan­els and the Pen­tagon say that the mea­sure would save lives by en­sur­ing that sol­diers in com­bat sit­u­a­tions get cut­ting-edge treat­ments.

Capi­tol Hill talks to re­solve the dis­pute are now un­der­way. The FDA and the lead­ers of the health com­mit­tees fa­vor a dif­fer­ent ap­proach that would cre­ate an ex­pe­dited process for the Pen­tagon’s emer­gency-use re­quests. That would be sim­i­lar to the FDA’s “break­through” des­ig­na­tion for promis­ing drugs for se­ri­ous or lifethreat­en­ing con­di­tions. If law­mak­ers agree on new lan­guage, it could be of­fered as an amend­ment to the de­fense bill or in fu­ture leg­is­la­tion. The House-Se­nate con­fer­ence re­port filed Wed­nes­day, which in­cludes the pro­vi­sion to al­low un­ap­proved drugs and de­vices, could be voted on by the House as soon as next week.

FDA Com­mis­sioner Scott Got­tlieb on Tues­day ex­pressed un­hap­pi­ness with the de­fense-bill lan­guage, say­ing med­i­cal-prod­uct ap­provals should be kept un­der his agency's con­trol.

“We think we pro­vide a level of over­sight that helps en­sure the safety of prod­ucts, helps fol­low up to make sure that if there are ad­verse events we’re mon­i­tor­ing them; we’re col­lect­ing that in­for­ma­tion,” he said.

Navy Cmdr. Gary Ross, a Pen­tagon spokesman, said the De­fense De­part­ment, if given the emer­gency au­tho­riza­tion, would ex­er­cise cau­tion. “If DOD is given this au­thor­ity, we would work closely with our FDA col­leagues to en­sure life­sav­ing treat­ments are fielded quickly while pro­tect­ing pa­tient safety,” he said.

Un­der the de­fense bill’s lan­guage, the Pen­tagon would be re­quired to cre­ate a panel of out­side ex­perts to rec­om­mend when an un­ap­proved prod­uct should be used, and de­fense of­fi­cials would have to con­sult with the FDA — but would not have to fol­low its ad­vice.

Con­gres­sional sup­port­ers of the pro­vi­sion say law­mak­ers are frus­trated over what they see as FDA de­lays in ap­prov­ing freezedried plasma, a de­hy­drated form of plasma that is in­tended to be quickly re­con­sti­tuted and given to sol­diers dur­ing mil­i­tary op­er­a­tions. Such plasma is be­ing used by a small num­ber of U.S. troops un­der lim­ited per­mis­sion from the FDA, and by some U.S. al­lies.

Got­tlieb said that the FDA could ap­prove the plasma as soon as 2018, more quickly than if the Pen­tagon had to de­velop its own re­view process.

The Pen­tagon pro­vi­sion has strong sup­port among de­fense com­mit­tee law­mak­ers of both par­ties, in­clud­ing Se­nate Armed Ser­vices Com­mit­tee Chair­man John McCain (R-Ariz.); rank­ing Demo­crat Sen. Jack Reed (R.I.); House Armed Ser­vices Com­mit­tee Chair­man Mac Thorn­berry (R-Tex.), and rank­ing Demo­crat Adam Smith ( Wash.).

In a let­ter to those law­mak­ers Thurs­day, five for­mer FDA com­mis­sion­ers who served in both Demo­cratic and Repub­li­can ad­min­is­tra­tions — Mar­garet Ham­burg, Jane Han­ney, David Kessler, Mark McClel­lan and An­drew von Eschen­bach — de­nounced the pro­vi­sion and said it “likely in­creases the risks for our mil­i­tary per­son­nel.”

Law­mak­ers who sup­port the FDA po­si­tion in­clude Sen. La­mar Alexan­der (R-Tenn.), chair­man of the Health, Ed­u­ca­tion, La­bor and Pen­sions Com­mit­tee; Sen. Richard Burr (R-N.C.), chair­man of the In­tel­li­gence Com­mit­tee; and Rep. Greg Walden, (R-Ore.), a mem­ber of the House En­ergy and Com­merce Com­mit­tee.

Michael Carome, di­rec­tor of Pub­lic Cit­i­zen’s Health Re­search Group, said it is a “hor­ri­ble idea” for the Pen­tagon to get au­tho­riza­tion to use un­ap­proved ma­te­ri­als on troops. “It will en­dan­ger the FDA’s au­thor­ity and en­dan­ger the sol­diers,” he said.

“It will en­dan­ger the FDA’s au­thor­ity and en­dan­ger the sol­diers.” Michael Carome, di­rec­tor of Pub­lic Cit­i­zen’s Health Re­search Group


FDA chief Scott Got­tlieb ob­jects to a De­fense De­part­ment pro­posal to al­low the emer­gency use of un­ap­proved drugs and de­vices.

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