FDA so­lic­its in­dus­try in­put for OND pol­i­cy pri­or­i­ties

A Fri­day FDA no­tice is so­lic­it­ing pol­i­cy sug­ges­tions from the in­dus­try that re­view staff at the FDA’s Of­fice of New Drugs (OND) can im­ple­ment in the near fu­ture.

To hear from in­dus­try on “spe­cif­ic, ac­tion­able pol­i­cy sug­ges­tions that could be im­ple­ment­ed in the near-term,” the FDA is so­lic­it­ing pre­sen­ta­tions for dis­cus­sions at a pub­lic meet­ing set via the Fed­er­al Reg­is­ter no­tice as well as invit­ing com­ments on the top­ics that the no­tice dis­cuss­es.

The meet­ing is set for 7 No­vem­ber, with the goal of so­lic­it­ing sug­ges­tions on read­i­ly and broad­ly ap­plic­a­ble poli­cies across var­i­ous ther­a­peu­tic ar­eas or dis­eases. This dif­fers from the in­put in­dus­try can of­fer for guid­ances and frame­works on high-pol­i­cy ini­tia­tives, such as to in­cor­po­rate re­al-world ev­i­dence and the sci­ence of pa­tient in­put in­to reg­u­la­to­ry de­ci­sion-mak­ing.

The fo­cus of the no­tice is cen­tered on di­rect­ing the at­ten­tion to five top­ics that are of par­tic­u­lar in­ter­est for the sug­ges­tions to aid OND in fo­cus­ing on pol­i­cy pri­or­i­ties while the FDA- and Cen­ter for Drug Eval­u­a­tion and Re­search (CDER)-wide high-pol­i­cy ini­tia­tives are un­der­way.

The FDA so­lic­its in­put about where OND can fa­cil­i­tate ad­di­tion­al guid­ance or sci­en­tif­ic dis­cus­sion in the near fu­ture to im­prove clar­i­ty and pro­mote ef­fec­tive drug de­vel­op­ment “for var­i­ous clin­i­cal ar­eas linked by a shared ther­a­peu­tic con­text,” such as drugs that are in­tend­ed for the treat­ment of se­ri­ous, life-threat­en­ing rare dis­eases. Spe­cif­ic sug­ges­tions can al­so be about where OND can un­der­take guid­ance or pol­i­cy de­vel­op­ment sup­port­ing drug de­vel­op­ment for dis­eases that are cur­rent­ly un­a­menable to tar­get­ed ther­a­pies. In­dus­try can share views on guid­ance, ben­e­fits, draw­backs to ex­tend­ing nov­el tri­al de­signs to ad­di­tion­al ther­a­peu­tic ar­eas and how to pro­mote ef­fec­tive drug de­vel­op­ment pro­grams when such ap­proach­es cause un­cer­tain­ty-re­lat­ed ten­sion.

The re­main­ing top­ic of par­tic­u­lar in­ter­est to the agency re­lates to the FDA guid­ances that are not dis­ease- or in­di­ca­tion-spe­cif­ic. The FDA wants to hear from those who may “be­lieve that OND re­view di­vi­sions are im­ple­ment­ing these guid­ances in dif­fer­ent ways.” It seeks rec­om­men­da­tions for top­ics where, “This may re­flect a need for guid­ance re­vi­sion or ad­di­tion­al pol­i­cy de­vel­op­ment.”

“Con­sis­tent with FDA’s broad­er ini­tia­tives and mod­ern­iza­tion ef­forts, the clin­i­cal and sci­en­tif­ic lead­ers of OND are seek­ing sug­ges­tions on where we can pro­vide reg­u­la­to­ry clar­i­ty to pro­mote in­no­v­a­tive and ef­fec­tive drug de­vel­op­ment across mul­ti­ple ther­a­peu­tic ar­eas,” the agency states in the no­tice. The move comes amid the mod­ern­iza­tion of OND, a FY 2019 pri­or­i­ty, and CDER.

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So­cial im­age: FDA, AP Im­ages

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

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