FDA ex­e­cutes a 180 on Ther­a­peu­tic­sMD ther­a­py, hand­ing it an OK — and stok­ing con­cerns about po­lit­i­cal in­flu­ence

A year af­ter the FDA hand­ed Ther­a­peu­tic­sMD $TXMD a re­jec­tion let­ter for its ther­a­py pre­vent­ing vagi­nal pain dur­ing sex, the agency has done a com­plete 180 — ap­prov­ing the treat­ment af­ter wav­ing off the safe­ty con­cerns that had once war­rant­ed a CRL.

The de­ci­sion to drop the CRL and al­low the ap­pli­ca­tion to pro­ceed with­out meet­ing spec­i­fied hur­dles is one of three the FDA ex­e­cut­ed in the weeks af­ter Scott Got­tlieb jumped in­to the top job at the FDA, rais­ing con­cerns that po­lit­i­cal in­flu­ence was chang­ing the for­tunes of some of the com­pa­nies with busi­ness be­fore the agency. In this case, Got­tlieb — hand­ed a man­date to speed ap­provals — won the nom­i­na­tion the day af­ter the re­jec­tion was an­nounced by Ther­a­peu­tic­sMD.

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