The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioreg­num Opin­ion Col­umn by John Car­roll

A few weeks ago, when Stephen Hahn was be­ing light­ly queried by Sen­a­tors in his con­fir­ma­tion hear­ing as the new com­mis­sion­er of the FDA, he made the usu­al vow to main­tain the gold stan­dard in drug de­vel­op­ment.

Neat­ly sum­ma­rized, that stan­dard re­quires the agency to sign off on clin­i­cal da­ta — usu­al­ly from two, well-con­trolled hu­man stud­ies — that prove a drug’s ben­e­fit out­weighs any risks.

Over the last few years, bio­phar­ma has en­joyed an un­prece­dent­ed loos­en­ing over just what it takes to clear that bar. Reg­u­la­tors are more will­ing to drop the sec­ond tri­al re­quire­ment ahead of an ac­cel­er­at­ed ap­proval — par­tic­u­lar­ly if they have an un­met med­ical need where pa­tients are clam­or­ing for a ther­a­py.

That con­fir­ma­to­ry tri­al the FDA de­mands can wait a few years. And most every­one in bio­phar­ma would tell you that’s the right thing for pa­tients. They know its a ton­ic for every­one in the in­dus­try faced with push­ing a drug through clin­i­cal de­vel­op­ment. And it’s helped in­spire a glob­al biotech boom.

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