Posted 09 December 2016
By Zachary Brennan
The US Food and Drug Administration (FDA) on Friday published a manual of policies and procedures (MAPP) describing how staff from the Center for Drug Evaluation and Research (CDER) can engage in public-private partnerships and consortia to facilitate, inform, and help the external groups understand CDER’s current thinking in a role separate from any regulatory review process.
Under FDA’s Critical Path Initiative, Advancing Regulatory Science Initiative and similar programs, the agency engages with other government, academic, scientific, patient and industry organizations to foster scientific collaborations.
In addition to efforts to bridge scientific gaps in drug discovery and development, CDER is involved in several partnerships to promote the development of research tools, platforms, clinical databases and predictive models to advance knowledge of diseases and safety profiles of drugs.
“It is essential that CDER staff is aware of potential conflicts of interest and avoid any appearance of undue influence,” the MAPP says, noting this document is specifically for CDER staff involved in discussions with public-private partnerships and consortia convened by external entities.
As far as the terms of engagement, FDA notes that while the CDER public-private partnership liaisons can have general regulatory discussions, the liaison “will not engage in discussions directly related to any regulatory submissions, which are the responsibility of the CDER reviewers in the review team” and also “will not discuss other confidential or non-public information.”
As far as fundraising, the MAPP says CDER employees are prohibited from using their status as representatives of the federal government to solicit private funds. And public-private partners are similarly prohibited from appearing to solicit funds on behalf of CDER, FDA or the federal government.
CDER Staff Participation in Public Private Partnerships and Consortia