BIO, PhRMA outline PDUFA VI goals

The Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America said Wednesday that they intend to use the PDUFA reauthorization process to advance three goals: improving the integration of patient perspectives into drug development and regulatory decision-making; enhancing the scientific expertise, processes, and tools FDA uses to regulate medical products; and promoting the long-term stability of the PDUFA program. The trade associations outlined identical goals at a public meeting to launch negotiations for PDUFA VI.

BIO SVP for Science Policy Kay Holcombe said at the meeting it is essential for FDA and stakeholders to move patient-focused drug development "from an ad hoc and anecdote-driven approach to a robust, systematic, and data-driven process that occurs at each stage of drug development and review." Creating guidance and procedures for integrating patient preference research into drug regulation will be among BIO's and PhRMA's priorities for PDUFA reauthorization, Holcombe said (see BioCentury, June 29). ...