FDA Allows Rehearing Deadline to Pass in Misbranding Case

The Food and Drug Administration (FDA) did not file a motion for rehearing with the U.S. Court of Appeals for the Second Circuit by the January 16, 2013 deadline in the case of United States v Caronia. In so doing, the appellate court’s setting aside of the conviction of pharmaceutical sales representative Alfred Carornia’s stands. The FDA charged Caronia with: (1) conspiracy to introduce a misbranded drug into interstate commerce; and (2) introducing a misbranded drug into interstate commerce, both involving violations of 21 U.S.C. secs. 331(a) and 333(a)(2). Observers speculate that the FDA will not pursue any further action on this case as it might set a precedent across the country that would prohibit prosecution of these types of cases.


At trial, Caronia was found not guilty of introducing the drug Xyrem® into commerce. The jury did find Caronia guilty of conspiracy to market Xyrem while it was misbranded, but not marketing with knowledge that the labeling and warnings were inadequate. Xyrem is a central nervous system depressant that the FDA approved in 2002 for the treatment of narcolepsy patients with cataplexy, a condition involving weak or paralyzed muscles. The FDA required a “black box” warning label for Xyrem stating that: (1) it was approved only for patients between the ages of 16 and 65, (2) there was limited experience with use for patients over 65, and (3) it had not been tested on children. The FDA claimed that Caronia and a codefendant made statements to a physician posing as a prospective customer promoting the use of Xyrem to treat fibromyalgia, muscle disorders, chronic pain, and chronic fatigue syndrome. Caronia stated that the drug had been used with patients as young as 14 and, more frequently, with patients over 65.


By letting this decision stand, the FDA is not risking a ruling by the U.S. Supreme Court that would apply throughout the country. Allowing this conviction to be set aside would allow the FDA to pursue these types of action in other judicial circuits, as this ruling only applies to the Second Circuit, which is comprised of New York, Connecticut, and Vermont. Richard Samp, chief counsel of the Washington Legal Foundation, which filed a brief in support of Caronia, said in an article published at Pharmalot.com, “It indicates to me that rather than fight, they’re interested in finding a way to conduct business as they have.”

Ability to Prosecute

In addition, the FDA does not believe that the current ruling of the Court of Appeals for the Second Circuit will impact how it enforces the law. According to Pharmalot, an FDA spokeswomen said, “The FDA does not believe that the decision will significantly affect the agency’s enforcement of the drug misbranding provision of the Food, Drug & Cosmetic Act.” She continued, “The decision does not strike down any provisions of the FD&C Act or its implementing regulations, nor does it find a conflict between the act’s misbranding provisions and the First Amendment or call into question the validity of the act’s drug approval framework.” The appellate court noted that free speech protections do not extend to false or misleading statements.

The FDA has until March to seek a hearing before the U.S. Supreme Court, according to the Pharmalot report. In addition, the FDA could seek a 60 day extension to make its filing.