Biotech Values

[DewDiligence]

Re: FDA Citizen Petitions

Can some person/lawyer/entity file a citizen's petition and delay any possible approval?

If a CP is filed whose sole purpose in the view of the FDA is to delay an ANDA or 505b2 NDA, the petitioners may be subject to fines or other penalties.

Are there new rules regarding CPs regarding timelines and disclosures?

The FDA must disclose a CP and must rule on it within 180 days, unless the requests in the CP are moot pending the outcome of litigation. (An example of a moot CP is the one filed by Teva in 2008 regarding the NVS/MNTA ANDA for Copaxone.)

This monograph from a private law firm contains some handy info regarding FDA policy on CP’s:
http://www.fdli.org/conf/handouts/Rosen.pdf