Life Science Compliance Update

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November 10, 2016

FDA Off-Label Hearing: Day One


Yesterday, the Food and Drug Administration (FDA) kicked off a two-day public meeting to review the extent to which off-label information about medicines may be disseminated to physicians. The meeting opened with Dr. Robert Califf, Commissioner of the FDA, making brief opening remarks, followed by a slew of individual presentations.

The presentations were limited to eight minutes (joint presenters were given 16 minutes) and included speakers such as Mr. Michael Labson of Covington & Burling LLP, on behalf of Pharmaceutical Research and Manufacturers of America (PhRMA); Ms. E. Cartier Esham with the Biotechnology Innovation Organization (BIO); Ms. Khatereh Calleja of the Advanced Medical Technology Association (AdvaMed); Dr. Andrew Koenig of Pfizer Inc.; Dr. Edith Perez with Genentech; Dr. John Kamp with the Coalition for Healthcare Communication; and Ms. Jennifer Graff of the National Pharmaceutical Council.

The public hearing comes amongst a growing tide of court decisions and settlements that affirm the First Amendment right of pharmaceutical and medical device companies to engage in truthful, non-misleading speech about approved products, including off-label conditions of use.

Concerns of Both “Sides”

One of the FDA’s chief concern is that public health may be compromised if a company communicates an unapproved use that has not been confirmed to be safe or effective. According to Michael Carome, director of Public Citizen’s Health Research Group, “It is tremendously important that the FDA strongly regulate manufacturer communications regarding unapproved uses of approved or cleared medical products to protect public health. Without strong limits on such industry communications, our long-standing regulatory framework for ensuring that drugs and medical devices are safe and effective for their intended uses would be undermined, threatening patient health.”

Industry, on the other hand, is concerned that public health may be compromised if a company is not permitted to communicate relevant, truthful, non-misleading and clinically-proven information – even if the use is unapproved.

Deputy general counsel of BIO, Deborah M. Shelton, believes, “Removing current regulatory barriers, and clarifying the ability of companies to share truthful and non-misleading information about medicines, is essential to our collective ability to realize the full potential of 21st century medicines and helping to ensure that patients are able to get the right medicines at the right time for them.”


What is the FDA Looking For?

The FDA sought responses to a variety of questions, including: (1) how increased communications from firms about unapproved uses impact the public health and how it might differ across different categories of medical products and categories of communications; (2) what kind of information or systems currently exist to help the FDA determine how firms’ increased communication of information about unapproved uses could affect prescribing and medical product development and research; (3) whether or not there should be different approaches for different categories of medical products (i.e., human drugs and biologics, medical devices, animal drugs), or for different disease areas or patient populations; (4) what standards should apply to unapproved use communications to minimize the potential of these communications to be misleading or otherwise cause harm; and (5) what standards should the FDA otherwise use to determine whether or not the communications are truthful and non-misleading, including disclosures.

Consumer Reports

A Consumer Reports survey showed that a majority of Americans do not like the idea of allowing pharmaceutical companies to advertise a drug for a use that has not been approved by the FDA. Consumer Reports spoke at the meeting, calling on the FDA to maintain its ban on the “off-label” promotion of drugs and medical devices.

PhRMA Statement Released

In addition to Mr. Labson’s comments at the hearing, PhRMA president and CEO Stephen Ubl released a statement, noting that,

As the U.S. health care system evolves to become increasingly focused on value, patients, payers and providers seek more science-based safety, effectiveness and economic information about existing and emerging treatments for patients. The market for medicines is changing rapidly as alternative payment models proliferate and novel decision tools like value frameworks are being applied. Increasingly, prescribing decisions are made not by independent physicians, but influenced by the integrated delivery systems in which they practice or by financial incentives created by powerful health plans. In this changing environment, it is important that biopharmaceutical companies be able to share appropriate science-based information with population health decision makers, yet the U.S. Food and Drug Administration’s (FDA) current federal regulations have not kept up with this new reality.

Ubl continued, noting,  

Given our increasingly data-driven, value-based health care system, we hope the FDA will adopt a stepwise approach in defining new and clearer regulatory standards to permit responsible sharing of information and data about medicines with other parties in the health care system. The FDA should start by clarifying rules around information sharing with insurance companies and other population health decision makers by the end of the year. Such clarification – also requested by stakeholders in the insurance industry – will help improve the efficiency of our health care system and facilitate increased value-based care.


While any policy changes will not be immediate, the public meeting shows that the FDA is interested in listening to stakeholders, allowing them face time to speak and meet with FDA officials. Any change – even a small change – has the power to influence what kind of information patients receive on drugs and devices, and industry and the FDA have a responsibility to ensure public health remains a priority.

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