Corey Raines Quoted in Product Liability Law Reporter
The American Association for Justice published an article in its Product Liability Law Reporter on Dec. 10, 2013 titled “Battle Brewing over FDA Generic Drug Labeling Ruling.” The article, written by Courtney L. Davenport, is about the FDA’s proposed changes to generic drug labeling and features quotes from Wexler Wallace associate Corey Raines.
The FDA’s proposed rule would allow generic drugmakers to submit label changes once they learn of safety concerns – not once the brand-name manufacturer has initiated changes. Corey has written a number of posts for the Wexler Wallace blog regarding this topic; In particular the Supreme Court’s ruling in PLIVA, Inc. v. Mensing in 2011 and how the FDA’s subsequent proposed rulemaking would effectively overturn theMensing decision. In the AAJ article, she is quoted as saying:
“The FDA’s proposed rule is an acknowledgement of the inherent, significant problems that result from the inability of generic drug manufacturers to initiate changes to their labeling. Currently, consumers have no legal remedy should they be injured by a generic drug. In essence, this rule will make all drug manufacturers responsible for their products and protect the legal rights of consumers.”
To read the full article as it appeared in the Product Liability Reporter, click here. To read any of Corey’s articles regarding the Mensing decision, visit the Wexler Wallace Blog here, here and here.