Rethinking the Firewall: Considering Drug Costs in the FDA's Regulatory Policies.

Despite the profound impacts the U.S. Food and Drug Administration's (FDA) policy can have on consumers, the FDA has not put in place a framework for how drug pricing should be incorporated in its regulatory decision-making across administrations. We propose such a framework and identify four key domains in which the FDA can and should adopt pricing-aware policies: some actions FDA can take under its existing authority, some require new authority from Congress, and some require collaborations with other agencies in which FDA can play a key supporting role. These domains include: 1) improving generic competition, 2) reforming the Accelerated Approval pathway, 3) sharing data for transparency, and 4) applying temporary changes to enforcement policies. We also describe areas in which the FDA should not consider drug pricing in its policy to protect the integrity of regulatory decision-making at the FDA.