Bioequivalence and Bioavailability Forum

Dear All

Good morning

Over a couple of months we are struggling with the FDA-mandated Risk Evaluation Mitigation Strategies (“REMS”) which says if the branded drug is covered by REMS, distribution can be severely restricted, thereby eliminating access to the wholesalers and ultimately the generic manufacturers as well.

Earlier this year, response to the complaints of Generic Companies, an amendment known as Section 1131 was recently added to the Senate bill (here is the bill and here is the amendment), but the House version lacks this language (here is the bill).


Does anyone else has gone through this rough patch and know a way out of it or It is going to be a road to the center of black hole .


Luv