FDA guidance aims for loophole to avoid rebates

FDA has completed a draft guidance that would create a legal loophole for drug companies to bypass legal commitments to pay rebates to PBMs and payers. The guidance, which is under review at the Office of Management and Budget, is intended to allow companies to sell drugs at net prices that don’t include rebate payments.

If and when it is implemented, HHS believes the guidance would enable drug companies to create a parallel market that would function alongside regular supply chains. In this separate channel, imported drugs could be sold at lower list prices to patients who are uninsured or who have large deductibles. ...