Aca­d­e­mics and re­searchers raise con­cerns with FDA’s plan for ‘in­te­grat­ed re­views’

More than 50 aca­d­e­mics and re­searchers from Har­vard, Yale, Johns Hop­kins and oth­er uni­ver­si­ties around the world are call­ing on the FDA to not re­place its orig­i­nal re­views of med­ical prod­ucts with an “in­te­grat­ed re­view” be­cause of the valu­able in­for­ma­tion that would be lost.

The re­searchers claimed that such a shift would de­prive them of in­for­ma­tion and da­ta on the clin­i­cal stud­ies and tri­als sub­mit­ted to the FDA, in­for­ma­tion on the post­mar­ket­ing re­quire­ments, and re­view­er con­cerns with an ap­pli­ca­tion that might not be in­clud­ed in a sum­ma­ry doc­u­ment like the in­te­grat­ed re­view, among oth­er im­por­tant de­tails.

“The FDA should not re­place in­di­vid­ual re­views with an in­te­grat­ed re­view. Rather, an ad­di­tion­al doc­u­ment that sum­ma­rizes the in­di­vid­ual re­views can be pub­lished, as FDA has al­ready been do­ing in pub­lish­ing ‘Sum­ma­ry Re­view’ doc­u­ments,” the re­searchers wrote.

Sim­i­lar­ly, non­prof­it Pub­lic Cit­i­zen said it “strong­ly ob­jects” to the FDA’s pro­pos­al, which was first ex­plained in a June Fed­er­al Reg­is­ter no­tice. “This ill-con­ceived pro­pos­al would, at the least, be a ma­jor step back­wards in agency trans­paren­cy with re­spect to the da­ta that the agency re­lies on when ap­prov­ing new drugs or bi­o­log­ics and the agency’s as­sess­ment of these da­ta,” Pub­lic Cit­i­zen said.

Health tech­nol­o­gy com­pa­ny Flat­iron Health al­so not­ed that some of the sec­tions in the orig­i­nal doc­u­ment ap­pear to be miss­ing in the new in­te­grat­ed sum­ma­ry. “We al­so note that the new doc­u­ment is con­sid­er­ably short­er than the orig­i­nal, which sug­gests that some po­ten­tial­ly use­ful con­tent may be lost in the new for­mat. We urge FDA to en­sure that high­ly valu­able in­sight in­to re­view­ers’ think­ing is re­tained in the new in­te­grat­ed re­view for­mat. We are par­tic­u­lar­ly in­ter­est­ed in en­sur­ing that any ‘con­sul­ta­tive’ re­views from ex­perts out­side the core re­view team are in­clud­ed in the in­te­grat­ed sum­ma­ry re­view or oth­er­wise ac­ces­si­ble,” the com­pa­ny said.

In­dus­try group BIO, how­ev­er, said the new in­te­grat­ed tem­plate is an im­prove­ment over what the agency of­fers now, but al­so cau­tioned the FDA “to strict­ly lim­it dele­tions to the in­for­ma­tion re­peat­ed across re­view doc­u­ments rather than in­for­ma­tion that FDA deems to not be im­por­tant to ex­ter­nal en­ti­ties.”

BIO of­fered the ex­am­ple of the FDA re­cent­ly trim­ming the con­tent of pub­licly post­ed ac­tion pack­ages, which led to the elim­i­na­tion of “a sig­nif­i­cant num­ber” of meet­ing min­utes. In­dus­try group PhRMA al­so said it is im­por­tant for the FDA to en­sure that the com­bi­na­tion of the in­te­grat­ed re­view doc­u­ment and its ap­pen­dices “is no less com­pre­hen­sive than the ex­ist­ing doc­u­men­ta­tion that is post­ed on Drugs@FDA.”

BIO added: “These doc­u­ments for non-mile­stone de­vel­op­ment phase meet­ings, mid­cy­cle com­mu­ni­ca­tions, and late-cy­cle meet­ings are im­por­tant for stake­hold­ers’ un­der­stand­ing of the evo­lu­tion of the FDA’s think­ing dur­ing the de­vel­op­ment pro­gram and through­out the Agency’s re­view of an ap­pli­ca­tion. Like­wise, ad­min­is­tra­tive and cor­re­spon­dence doc­u­ments should con­tin­ue to be made avail­able.”

On the top­ic of the FDA con­tin­u­ing to re­lease spon­sors’ clin­i­cal study re­ports (CSRs), which the agency is con­sid­er­ing end­ing, the aca­d­e­mics and re­searchers al­so dis­agreed with BIO on what to do.

The aca­d­e­mics and re­searchers of­fered their sup­port for the FDA to con­tin­ue its ef­forts to re­lease CSRs, even though on­ly one has been re­leased so far. But BIO and PhRMA said that the re­lease of CSRs should not be pur­sued by the agency.

BIO al­so called on the FDA to work with the Eu­ro­pean Med­i­cines Agency and Health Cana­da to bet­ter align its trans­paren­cy ef­forts.


RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

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