Government,
Administrative/Regulatory
May 30, 2018
Citizen pathway for raising drug approval concerns gone astray
FDA citizen petition abuse is an instrumental anti-competitive tool that pharmaceutical companies use to delay market entry of generic drugs, an empirical study demonstrates.
Robin Feldman
Professor
UC Hastings College of the Law
Robin is director of the Institute for Innovation Law at UC Hastings College of the Law.
As the White House and the Food and Drug Administration look to crack down on pharmaceutical companies for "gaming the system," strategic behaviors that block inexpensive generics are getting an increasing share of the spotlight. One of these games involves abuse of the citizen petition system at the FDA.
Originating in the 1970s, the citizen petition process was created to provide ordinary citizens with a forum for raising concerns...
For only $95 a month (the price of 2 article purchases)
Receive unlimited article access and full access to our archives,
Daily Appellate Report, award winning columns, and our
Verdicts and Settlements.
Or
$795 for an entire year!
Or access this article for $45
(Purchase provides 7-day access to this article. Printing, posting or downloading is not allowed.)
Already a subscriber?
Sign In