If people can promote drugs for uses that lack supporting evidence, it would turn back the clock to the pre-1962 world of medicine where there wasn’t any research or data on what medicines worked and what was harmful, says Robert Temple, deputy director for clinical science at FDA’s Center for Drug Evaluation and Research (CDER).
Long regarded as FDA’s leading authority on what constitutes sufficient evidence for new drug approval and for claims made in drug marketing and promotion, Temple made clear his deep fears about the recent U.S. v. Caronia ruling at the Elsevier’s FDA/CMS Summit in Washington Dec. 11.
Medicine changed in 1962 with legislation that requires pharmaceutical companies to develop clinical data on what works for medical products and what doesn’t. “Before that, there wasn’t any evidence,” Temple recalled. But with this ruling, he added, sponsors would not have to bother getting clinical data on additional uses of an approved drug. Such research, though, is very important, Temple explained, noting that it led to most of the important cardiovascular treatments of recent years. Conversely, permitting marketers to promote unproven uses, he warned, could “kill vast numbers of people.”
While FDA could try to curb off-label promotion by challenging specific claims as untruthful and misleading, that would impose a huge burden on the agency, Temple commented. “If we have to do it case by case, it’s over.”
Temple recommended that everyone read the vigorous dissent in this 2-1 decision from the 2nd Circuit Court of Appeals. Judge Debra Ann Livingston argued that allowing drug companies to promote approved drugs for nonapproved uses would give sponsors “little incentive to seek FDA approval for those uses.” FDA lawyers are poring over the decision and are expected to seek a rehearing before the circuit court’s full panel of judges. The next stop could be the Supreme Court, especially if other lower courts produce conflicting decisions on additional off-label promotion cases moving through the legal system.