The FDA has now poked a hor­net's nest of con­tro­ver­sy in the House. And that could sting Bio­gen's mega block­buster quest in Alzheimer's

Bio­gen has earned two pow­er­ful crit­ics in the House of Rep­re­sen­ta­tives as the storm of con­tro­ver­sy that sur­rounds their ex­per­i­men­tal Alzheimer’s drug ad­u­canum­ab now moves to Con­gress.

Rep. Frank Pal­lone, Jr., chair­man of the Com­mit­tee on En­er­gy and Com­merce, and Rep. Car­olyn Mal­oney, chair­woman of the Com­mit­tee on Over­sight and Re­form, an­nounced late Fri­day that their com­mit­tees would put a spot­light on the FDA’s de­ci­sion to hand Bio­gen a megablock­buster ac­cel­er­at­ed ap­proval based on a se­lec­tion of da­ta from con­flict­ing clin­i­cal stud­ies.

The lan­guage in their state­ment makes it crys­tal clear that they have some point­ed ques­tions for the reg­u­la­tors — led by FDA in­ter­im chief Janet Wood­cock — about the broad-la­bel OK that puts the drug in front of mil­lions of des­per­ate Alzheimer’s pa­tients for $56,000, a price which will be am­pli­fied by re­lat­ed pro­ce­dures to mon­i­tor pa­tients:

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