Standing up for the Invisible Manufacturers

Contract manufacturers are unsung heroes. They produce medicines to the same quality standards as pharma companies and comply with the same regulations, but they do not receive the same profits as their pharma counterparts, nor recognition by patients. Their name does not go on the label of the medicines they help develop, and regulators and legislators have tended to overlook the outsourcing sector when making crucial decisions. The issue was highlighted in 2013, with the introduction of Generic Drug User Fee Amendments (GDUFA). These user fees, negotiated by the FDA, the generic industry and several other industry groups, were structured in a way that unintentionally created a large fee burden on contract manufacturing facilities in the generics space. When the sector started to receive invoices from FDA, they wondered why they were bearing this burden when they hadn’t been invited to the negotiating table.

The reaction? The birth of the PBOA. Without an association, things like GDUFA could come up again and, to quote an adage from a senator of Louisiana, “If you’re not at the table you’re probably on the menu…”