The FDA is finally taking steps to overhaul its constitutionally flawed off-label prosecutions of device and drug makers by holding a two-day public hearing on November 9 and 10, 2016, to consider, “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”
FDA Public Hearing to Reconsider “Off-Label Marketing” Prohibitions
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Multiple federal district courts have held that manufacturers, sales people and physicians have a first amendment right of free speech to disseminate and receive truthful information about a drug or device even if the agency has not given permission to make the statement.
The manufacturers have had to go to court because the agency filed criminal charges against them for off-label marketing.
This past March the agency settled a lawsuit with the drug maker Amarin after a U.S. District Court ruled that Amarin’s statements about Vascepa, a treatment of persistently high triglycerides, were “truthful and non-misleading.” Previous decisions in the cases of Caronia and Vascular reached the same free speech conclusions.
“Truthful and Non-Misleading”
Coming up with new standards to determine what is “truthful and non-misleading” will be challenging.
The agency says it is interested to learn about the extent to which additional communications about unapproved uses, “can provide access to information that is relevant, scientifically sound, responsibly presented, and provides as full an understanding as possible about the limitations of the available evidence, as well as comment on the extent to which health care professionals currently face impediments to accessing such information, whether from firms or from other sources.”
The agency also said it is interested in comment and information addressing “whether and in what ways firms” communications of unapproved use information are distinct and perhaps provide unique benefits compared to other sources.
The announcement of the meeting stated, “Not all communications of information about unapproved uses help support public health. For example, communications that emphasize a medical product’s claimed benefits, while minimizing the limitations of the supporting evidence, or minimizing the product’s known or potential adverse effects, may inappropriately influence prescribing or use decisions in a manner that is not in a patient’s best interest.”
If you want to attend or present at the hearing, you must register by October 19, 2016. Electronic or written comments will be accepted after the public hearing until January 9, 2017.
The hearing will be held at the FDA White Oak Campus, 10903 New Hampshire Ave, Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, Maryland.
You can watch a live Webcast of the hearing at: http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm489499.htm, on the day of the public hearing.
To read the background information about the purpose and goals of the hearing, click here.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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