The Pharmaceutical Research and Manufacturers of America supports having generic companies play an equal role in monitoring drug safety, but it argues that FDA should approve all safety-related labeling changes before they are implemented.
FDA Generic Labeling Rule: PhRMA, GPhA Offer Degrees Of Dislike
GPhA argues it would be impossible for ANDA applicants to unilaterally change their labels; Pfizer suggests FDA only allow one request for a proposed labeling change on a given safety issue at a time.