Industry More Than Ready for FDA Off-label Communications Guidance

Feb. 2, 2016 – The FDA’s recent announcement regarding which new and revised guidance documents it plans to publish in 2016 includes four long-awaited guidance documents by the Office of Prescription Drug Promotion (OPDP).

“While the agency has been pondering its options, consumers and health professionals are expecting the industry to move forward and participate in social media and off-label conversations,” said Coalition for Healthcare Communication Executive Director John Kamp. “OPDP has been talking about social media and off-label communication guidances for years. It’s great to see them high on FDA’s policy agenda,” he said.

The topics of the advertising-related guidances to be published this year are:

  • Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs
  • Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-party Sites
  • Presenting Risk Information in Prescription Drugs and Medical Devices Promotion (Revised Draft)
  • Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Licensed or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices

“I look forward to the agency’s views on communicating economic information to formularies under section 114 of FDAMA,” said APCO Worldwide’s Wayne Pines. “This type of information is becoming more important as new drugs are developed and as insurers make critical decisions about what they will reimburse for,” Pines noted. “I would hope that the guidance is clear and provides a safe harbor for companies seeking to provide useful information about approved or about to be approved drugs.” He also observed that the scientific exchange guidance will not be issued in 2016. “The document that FDA drafted on this appears to be held up at the HHS level,” according to Pines.

Although industry has been clamoring for more guidance from the FDA on all of these topics, in light of landmark First Amendment decisions across the federal court system, the off-label guidance is one of the most-anticipated documents by medical product companies. Indeed, the Pharmaceutical Research and Manufacturers of America told the Coalition that “We support the updated guidance from FDA to enhance data-driven information-sharing with healthcare professionals and patients.”

Peter Pitts, president and co-founder the Center for Medicine in the Public Interest, told the Coalition that the FDA needs to lead on this issue and at last seems to understand that if it does not, “it will be kicked in the head in court.”

In an article published last October in Morning Call, Pitts said that so far, “It would be generous to call the FDA’s views on the dissemination of off-label information ad hoc.” He told the Coalition that “if I was in the FDA right now, I would try to find another approach – instead of ‘is it on or off the label?’ the questions should be ‘is it truthful and non-misleading?’ and ‘is it useful to the public health?’” He added that “hopefully the agency will address this matter sooner rather than later.”

Movement toward permitting “truthful and non-misleading” communication continues in the federal courts, according to an article posted Feb. 1 in Policy and Medicine, which stated that in U.S. v. Vascular Solutions Inc. and Howard Root, a medical device case in the U.S. District Court for the Western District of Texas, the Department of Justice provided jury instructions indicating that “the federal government is actively warming up to the idea that the law, specifically the FDCA, does not criminalize truthful off-label promotion.”

Specifically, the jury instructions state the following, under the heading “Unapproved Use by Doctors”:

“Doctors may use medical devices that have been approved or cleared for one use for a different use that has not been cleared or approved by the FDA. This is often referred to as unapproved use or off-label use. This is not illegal. It is also not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”

“The DOJ shift in jury instructions on off-label cases is another signpost that it’s time for the FDA to provide updated policy guidance that enables industry to speak freely about new and emerging uses for approved products,” Kamp asserted. “Assuming action on the four guidance items slated for this year, we shall see significant changes in FDA marketing policy,” he said. “Congress, patients, caregivers and health professionals, as well as industry, will all be watching carefully.”