Press Release

Statement: Release of 2013 PDUFA Fees in Spending Package

PhRMA January 14, 2014

WASHINGTON, D.C. (January 14, 2014) – Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President of Scientific and Regulatory Affairs Sascha Haverfield, PhD, issued the following statement on the release of sequestered prescription drug user fees included in the omnibus spending package filed yesterday:

“PhRMA greatly appreciates the efforts of members of the House and Senate Appropriations Committees as well as leaders in both Chambers who have worked tirelessly over the past year to find a bipartisan resolution to restore the Food and Drug Administration’s (FDA) access to the sequestered FY2013 Prescription Drug User Fee Act (PDUFA) funds. The release of these funds will benefit patients, public health and regulatory science.

“We look forward to working with the FDA as the Agency pursues implementation of the regulatory science initiatives which were a key component of the PDUFA V technical agreement but were negatively impacted by the sequestration of PDUFA user fees.”

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