PBOA Supports Legislation to Protect FDA User Fees

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-03-04-2015, Volume 11, Issue 3

The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.


The Pharma & Biopharma Outsourcing Association (PBOA) issued a statement On Feb. 27 praising US Representatives Leonard Lance (R-NJ) and Anna Eshoo (D-CA) for introducing the FDA Safety Over Sequestration Act, or FDA SOS Act (H.R. 1078). The Act would exempt privately-paid user fees paid to the FDA from any future sequestration.

"The PBOA commends Representatives Lance and Eshoo for their bipartisan efforts taking the lead on this important issue. User fees comprise nearly half of the FDA’s budget and help the Agency reach performance milestones for regulatory review, thorough and timely inspections, and IT implementation," said PBOA President Gil Roth in a statement.

"PBOA's members provide the services that help the pharma and biopharma industry develop and manufacture drugs, biologics, vaccines, and other treatments safely and cost effectively. User fees, whether paid by their clients or by them directly, are integral to advancing this mission and ultimately bringing those treatments to patients. While recent budget deals have restored cuts through FY15, the FDA SOS Act would provide a permanent fix and remove the threat and uncertainty that sequestration would create for the Agency," he continued.


"We look forward to working with Congress, industry and other stakeholders to address this issue and preserve FDA’s access to the user fees it collects," Roth added.

The Pharma & Biopharma Outsourcing Association is a nonprofit trade association dedicated to advancing the regulatory, legislative and general business interests of Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs).

Source:  The Pharma & Biopharma Outsourcing Association