In the News

Kevin Zielke and Joshua Joseph Co-Author Article for Pharmaceutical Compliance Monitor

December 16, 2014

Kevin M. Zielke, Detroit-based member and Leader of Dykema’s Pharmaceutical Team, and Joshua H. Joseph, Washington, D.C.-based associate in the firm’s Products, Class Actions & Professional Liability practice, co-authored the article, “The Plaintiff Bar’s Latest Attack on Generic Drug Manufacturers: How a New FDA Rule Could Dismantle Recent Legal Victories,” which appeared in Pharmaceutical Compliance Monitor.

In the article, Zielke and Joseph discussed the Food and Drug Administration’s (FDA) issuing a Notice of Proposed Rulemaking that would effectively deprive generic manufacturers’ preemption defense by allowing generic manufacturers to independently update their products labels. The authors point out that the rule change would effectively force generic manufacturers to operate like their brand-name counterparts, which they are not equipped to do, and could come at great expense to consumers.

To read the entire article, click here.