The Nightmare Before Christmas

  • by: |
  • 12/18/2012

Bob Temple is having nightmares – and it’s not because of too much coffee before bedtime.

Bob envisions a nightmare situation if the Caronia ruling enables companies to promote drugs for uses that are not supported by well-controlled clinical trials.

Temple, deputy director for clinical science in the Center for Drug Evaluation and Research, discussed the decision at the FDA/CMS Summit in Washington Dec. 11. The U.S. Court of Appeals for the Second Circuit ruled in United States v. Caronia that the government cannot prosecute pharmaceutical manufacturers or their representatives under the Food, Drug, and Cosmetic Act for speech promoting the lawful, off-label use of an approved drug.

“What is worth talking about is what the consequences would be if people could promote uses that they hadn’t established, hadn’t bothered to get through the system,” Temple stated. “I’m horrified by that.”

Temple expressed concern that the Caronia ruling could undermine the 1962 amendments to the FDCA, which require that drugs be proven to be effective as well as safe. He said that prior to 1962 people did not know whether drugs worked. “If this [ruling] were to change the situation so that yes, people had to get their first claim in with adequate and well-controlled studies, but after that they didn’t have to bother anymore, and if that made them not bother anymore, that would be a nightmare.”

“There are all kinds of things that if you didn’t know the answer [it] would be terrible, and having people promote those uses is frankly terrifying,” said Temple.

“First of all, things that are wonderful would never be approved,” he stated, noting that most of the known cardiovascular outcomes were secondary outcomes. “There are all kinds of things that if you didn’t know the answer [it] would be terrible, and having people promote those uses is frankly terrifying.”


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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