The FDA’s very pub­lic slap of No­var­tis’ red face is a warn­ing to the en­tire in­dus­try — don’t down­play it

In drug de­vel­op­ment, there’s an un­writ­ten rule that the FDA can re­ly on the deep-pock­et glob­al play­ers to pro­duce clean da­ta. The re­sults may be pos­i­tive or neg­a­tive, and you’re free to in­ter­pret as you please, but the da­ta are re­li­able.

All the da­ta, from hu­mans right down to the mice. 

Trust in the in­tegri­ty of the peo­ple hand­ing over the da­ta is es­sen­tial for the cur­rent em­pha­sis on ac­cel­er­at­ed ap­provals. If the top play­ers start gam­ing the sys­tem, every­one can go back to the clin­ic and plan to plod through each stan­dard phase of clin­i­cal tri­als, with a long, slow reg­u­la­to­ry re­view at the end.

Re­mem­ber how well that worked?

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