US Food and Drug Administration–Approved Laboratory Tests After Caronia

In the January 2013 edition of the ARCHIVES, I described, in ‘‘Food and Drug Administration Approval of Laboratory Tests,’’ 1 the US Food and Drug Administration’s (FDA’s) off-label drug conundrum, and how it might apply (or chaos it might cause) were the FDA to begin approving laboratory tests. The month before the article’s January publication, the United States Court of Appeals for the Second Circuit handed down its opinion in United States versus Caronia, a case directly addressing the off-label issue, and for which a brief discussion as to its potential effect on FDA-approved laboratory tests is appropriate. In Caronia, a physician who had been convicted of health care fraud cut a deal to lighten his sentence and joined a Department of Justice (DoJ) sting operation during which he recorded pharmaceutical representative Alfred Caronia making ‘‘truthful, nonmisleading’’ statements about the uses of a narcolepsy drug, Zyrem. Caronia’s statements contained information pertaining to the use of the drug ‘‘that had been studied in clinical trials but were not approved [by the FDA].’’ 3 Caronia was tried and convicted of the crime of ‘‘conspiring to introduce a misbranded drug into interstate commerce.’’ 3 Caronia received a criminal sentence, which he appealed. Many legal experts have been concerned for some time that the FDA’s schizophrenic stance on off-label speech violates free speech protected by the First Amendment. Criminalizing truthful, nonmisleading speech by pharmaceutical representatives—speech that essentially anybody else is able to say—has produced an unsustainable tension, finally addressed by the Second Circuit in Caronia’s appeal. The Second Circuit concluded that ‘‘the government clearly prosecuted Caronia for his words—for his speech’’ and ‘‘slapped down [the] FDA’s and DoJ’s long-standing contention that the Food, Drug & Cosmetic Act (FDCA) makes it illegal for drug companies and their employees to communicate about an off-label use.’’ 3 Indeed, the Second Circuit went even further, asserting that ‘‘it is in the public interest for drug companies to discuss off-label uses with physicians.’’ 3 The Second Circuit’s Caronia decision has the potential to significantly change the FDA’s stance on approving laboratory tests. The court’s decision, dealing with First Amendment free speech rights, does not directly address laboratory tests. The FDA’s strained designation of laboratory tests as ‘‘medical devices,’’ a designation used entirely to assert control over them, remains intact. The FDA’s ability to grant approval of laboratory tests, including the promotion of so-called companion tests, also remains intact; this is so even as one struggles to determine just exactly how a molecular test could be ‘‘configured to work specifically in [non-small cell lung cancer] patients.’’ 1 Caronia changed the paradigm, freeing drug vendors to speak openly, with First Amendment protection, about FDA-approved and FDA-nonapproved (‘‘off-label’’) uses for drugs and medical devices. The success of ‘‘companion tests’’ has depended on the pre-Caronia environment allowing the FDA to restrict speech about alternative, offlabel tests; however, now that Caronia allows truthful, nonmisleading speech about these other tests, the marketing appeal of the companion test may rapidly wane. Taken in full, the holding could eliminate the newly minted companion test entirely, by eliminating the FDA-produced monopoly incentives that come with a test being labeled a companion test. Because Caronia is the ninth straight First Amendment case the FDA has brought and lost, and only applies to 3 states, it is unlikely the Obama administration will attempt Supreme Court review. For the FDA, the Caronia ‘‘decision was the Nightmare Before Christmas.’’ 4 Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research was ‘‘horrified’’ that the Second Circuit has held that a drug vendor’s truthful, nonmisleading speech is protected speech under the First Amendment. Other stakeholders in FDA litigation have generally had a ‘‘subdued’’ response to Caronia, noting that ‘‘it will be a long time before we figure out the true meaning of the case.’’ 3 Some stakeholders termed Judge Debra Ann Livingston’s Caronia’s dissent, referencing the famous Arsenic and Old Lace, ‘‘well-reasoned;’’ however, Richard Epstein demolishes it, noting, ‘‘[s]he is surely correct to write that, even if there is no law forbidding the consumption of arsenic, ‘this would not endow Abby and Martha with a First AmendAccepted for publication February 12, 2013. Published as an Early Online Release March 15, 2013. From the Department of Pathology and Laboratory Medicine, The University of Texas Health Science Center at Tyler. The author has no relevant financial interest in the products or companies described in this article. doi: 10.5858/arpa.2013-0020-ED Reprints: Timothy Craig Allen, MD, JD, Department of Pathology and Laboratory Medicine, The University of Texas Health Science Center at Tyler, 11937 Hwy 271, Tyler, Texas 75708-3154 (e-mail: timallenmdjd@gmail.com/timothy.allen@uthct.edu).