Study: Just half of post­mar­ket­ing com­mit­ment tri­als are pub­lished

A new study pub­lished Mon­day in BMC Med­i­cine finds that on­ly about half of the clin­i­cal tri­als re­quest­ed by the FDA as part of post­mar­ket­ing com­mit­ments for new­ly ap­proved drugs and bi­o­log­ics are pub­lished in peer-re­viewed jour­nals.

The study al­so found that in­for­ma­tion for near­ly half of the post­mar­ket­ing com­mit­ment stud­ies sub­ject to re­port­ing re­quire­ments un­der sec­tion 506B of Fed­er­al Food, Drug, and Cos­met­ic Act (FD­CA) was not up to date.

Con­duct­ed by re­searchers at Yale Uni­ver­si­ty, Uni­ver­si­ty of Con­necti­cut and Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, the study re­viewed post­mar­ket­ing com­mit­ments for the 110 new drugs and bi­o­log­ics ap­proved from 2009-2012.

Un­like post­mar­ket­ing re­quire­ments, which drug­mak­ers must con­duct as a con­di­tion of ap­proval, post­mar­ket­ing com­mit­ments are agreed to by drug­mak­ers at the time of ap­proval and are not re­quired un­der statute or reg­u­la­tion.

More than half (55.5%) of the 110 ap­provals had one or more post­mar­ket­ing com­mit­ment(s), with 33 re­quir­ing a new clin­i­cal tri­al. Of those, 27 were sub­ject to Sec­tion 506B re­port­ing re­quire­ments.

For the stud­ies sub­ject to re­port­ing re­quire­ments, 12 (44.4%) were nei­ther closed nor had an up-to-date sta­tus in pub­licly avail­able data­bas­es on the FDA’s web­site.

The study did find, how­ev­er, that near­ly all the clin­i­cal tri­als re­quest­ed as part of post­mar­ket­ing com­mit­ments were reg­is­tered on Clin­i­cal­Tri­ (90.3%), most of which were marked as com­plet­ed or ter­mi­nat­ed (82.1%). Of the com­plet­ed or ter­mi­nat­ed stud­ies all but one had re­port­ed re­sults.

How­ev­er, the au­thors found that most of the stud­ies (81.8%) that had re­port­ed re­sults on Clin­i­cal­Tri­ re­port­ed their re­sults af­ter the sched­uled sub­mis­sion dead­line.

On­ly about half of the stud­ies that were el­i­gi­ble for pub­li­ca­tion (i.e. com­plet­ed or ter­mi­nat­ed in Clin­i­cal­Tri­ or sub­mit­ted, ful­filled or re­leased ac­cord­ing to the FDA) were pub­lished in peer-re­viewed jour­nals.

“Among the 29 reg­is­tered or un­reg­is­tered stud­ies for which pub­li­ca­tion would be ex­pect­ed based on the most re­cent sta­tus pro­vid­ed by the FDA, phar­ma­ceu­ti­cal com­pa­nies, or on Clin­i­cal­Tri­, just un­der half were pub­lished in a peer-re­viewed jour­nal (14 of 29 (48.3%)),” the au­thors write.

And while post­mar­ket­ing com­mit­ments on­ly make up 19% of the postap­proval com­mit­ments and re­quire­ments im­posed by the FDA, the au­thors say the da­ta gen­er­at­ed by post­mar­ket­ing com­mit­ments “may be a po­ten­tial­ly im­por­tant source of in­for­ma­tion about drug and bi­o­log­ic safe­ty and ef­fec­tive­ness af­ter mar­ket ap­proval.”


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.

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