FDA Explains Decision Not to Seek Rehearing in Caronia

Yesterday FDA explained why it did not seek a rehearing of the Second Circuit’s December 3, 2012 decision in United States v. Caronia. In its decision (previously discussed here), the Second Circuit overturned the conviction of a sales representative for encouraging doctors to prescribe the suppressant Xyrem for off-label use. The court held that the sales representative’s promotion was speech and that the government could not restrict such speech under the 1st Amendment.  In concluding that the conviction violated the representative’s First Amendment rights the court held that the government did not establish the necessary reasons why it was necessary to restrict such speech given that others were legally entitled to deliver the same message and the government did not prove that the representative’s comments related to off-label use were false.

FDA explained its decision as follows: “FDA does not believe that the decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug & Cosmetic Act. The decision does not strike down any provision 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.”

With its statement, it appears FDA is attempting to narrow the Caronia decision. FDA’s statement  also sends a strong message that it will continue to address off-label promotion but will likely do so under the prohibition on misbranding in 21 U.S.C. § 352 rather than utilizing the “pure speech” approach employed in Caronia. Stated differently, FDA will assert that the shipment of product in response to off-label promotion is prohibited conduct (not speech) under current FDCA misbranding provisions.  The government will probably try similar cases in the future by attacking the conduct of shipping the product rather than challenging just the speech about the off-label use. It may be some time yet before we see whether FDA will change its approach to seeking recoveries for off-label promotion under the False Claims Act.  FDA’s announced position that the Caronia decision does not change the current state of law would seem to indicate that it will not seek certiorari.

Today’s post was contributed by Ralph Hall and Eric Marshall.

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