Two bills were introduced in Congress last week aimed at forcing biopharma companies to reduce the waste, and cost, of excessive doses in single-use vials and to pick up the tab for a nationwide drug disposal program. Sens. Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) introduced the Reducing Drug Waste Act in the Senate. The bipartisan bill would require the FDA to coordinate with the Centers for Medicare and Medicaid Services (CMS) in developing a joint action plan to better manage costs with respect to drug vial sizes and other drug delivery systems and to reduce the waste resulting from oversized single-use doses. The FDA and CMS also would have to submit a report to Congress with recommendations for further legislative action that might be needed. A different waste issue is addressed by a bill Rep. Louise Slaughter (D-N.Y.) introduced in the House in the wake of National Drug Take Back Day. Her bill is intended to create a framework for disposing of unused opioids and other prescription drugs. In introducing the bill, Slaughter called on Congress to do more to "hold the producers of these drugs – the big pharmaceutical companies – accountable for the safe disposal of the products that make them billions in profits." The Pharmaceutical Stewardship Act would do on a national scale what some counties and city governments have done locally by requiring biopharma manufacturers to foot the bill for drug collection and disposal at locations where the drugs are dispensed.

The FDA is recognizing eight European drug regulatory authorities as capable of conducting drug manufacturing inspections that meet its requirements. As a result, the FDA will rely on the inspection data obtained by regulatory agencies in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K. as part of the mutual recognition agreement it signed with its European counterparts. The agency is on track to meet its goal of assessing the capabilities of the regulatory agencies in all 28 EU member countries by July 2019.