FDA and Drug Pricing: Lowering The Cost of Capital – Not The Cost Of Drugs
Executive Summary
FDA regulatory reforms have been framed as part of the drug pricing debate. Commissioner Gottlieb has reframed the goal as lowering the cost of capital by increasing predictability. That probably won’t lower drug prices – but it might lower the cost of future acquisitions for drug companies.
You may also be interested in...
FDA's 21st Century Cures Plan Gives Patient-Focused Drug Development A Boost
US agency will hold five workshops and develop seven guidance documents focused on patient input in the drug development and review process; since some guidance requirements under Cures law overlap with those in PDUFA VI commitment letter, most of the funding will come from user fees.
Trump Exec Order On Drug Costs: Seeking To Balance Access, Innovation
Draft version of order signals a focus on insurance benefit design, accelerating drug approvals and de-regulation.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.