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Discovery & Development Contract Development Services, Contract Manufacturing Services

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…”

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About the Author

Gil Roth

Gil Roth is the founder and president of the Pharma & Biopharma Outsourcing Association (PBOA). In 1999, he helped launch Contract Pharma, which swiftly became the premier magazine covering the pharma/biopharma outsourcing and contract services industry. He served as editor of Contract Pharma from October 1999 until February 2014, chronicling the evolution of the pharmaceutical outsourcing sector.
In 2013, while reporting on an article about the Generic Drug User Fee Amendments (GDUFA), Roth had the idea to build a trade association for CMOs and CDMOs, in order to provide them with a voice in regulatory and legislative areas and to raise awareness of the pivotal role they play in healthcare.

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