The U.S. Court of Appeals for the Federal Circuit has ruled in a new en banc decision that individuals employed by importers, or corporations that are not the “importer of record,” may be liable under civil penalty laws because of their role in introducing articles into U.S. commerce. This decision represents an important increase in the risk faced by individuals working for importing companies and other firms in the global supply chain.
The Food and Drug Law Institute (FDLI) will hold its “Understanding cGMPs—What Attorneys Need to Know” conference at the Washington, DC office of Hogan Lovells on July 15, 2014. During the conference, which is specifically tailored for lawyers but appropriate for all drugs and biologics stakeholders, attendees will hear from top FDA/CDER Compliance officials, in-house counsel, Hogan Lovells’ lawyers, and others, on how FDA evaluates company compliance with current good manufacturing practice (cGMP) and responds to noncompliance. The conference will highlight recent cGMP developments and provide updates on FDA authority. It will also expand beyond the United States to consider global issues such as import/exports and international inspections.
Topics discussed at the recent Food & Drug Law Institute’s (FDLI) Enforcement, Litigation and Compliance Conference included FDA Center leaders’ enforcement priorities, interagency enforcement actions, the implications of increasing globalization, and the diversion of controlled substances. Among the highlights: Joseph Rannazzisi, Deputy Assistant Administrator in DEA’s Office of Diversion Control, said due diligence is the
To update our previous post on this subject, on July 20, 2012, the government filed its brief opposing KV’s request for injunctive relief and moved to dismiss the case. In its brief, the government argues that KV lacks standing to sue because, in June 2012—prior to KV filing suit—the agency posted on its website a statement and a
K-V Pharmaceutical Company (“KV”) and its wholly-owned subsidiary, Ther-Rx Corporation (“Ther-Rx”) filed suit in the U.S. District Court for the District of Columbia on July 5, 2012 against the FDA seeking declaratory and injunctive relief to “restore” KV’s 7-year orphan drug exclusivity for MAKENA (hydroxyprogesterone caproate or 17P) Injection, 250 mg/mL.