Product LiabilityPublications

Promoting Off-Label Use: Are the Times Changing at the FDA?

September 6, 2016Articles

FDA to hear comments about expansion of off-label communications

The Food and Drug Administration (FDA) has announced that it is engaged in a comprehensive review of its regulations and policies related to off-label communications. The FDA will hold a public hearing on November 9 and 10, 2016 from 9 a.m. to 5 p.m. to take comments on this issue.

Off-label use occurs when a physician prescribes or uses currently available and marketed medications or other products for an indication that has not received FDA approval. Pharmaceutical manufacturers cannot promote off-label use, but they are, under strict conditions, allowed to respond to unsolicited questions from health care professionals about off-label use and to distribute peer-reviewed publications regarding off-label use. Conversely, health care practitioners are generally permitted to prescribe approved medical products for off-label indications when they judge that it is medically appropriate for their individual patients. In fact, off-label use of a medication may be the standard of care, or even the only treatment, in certain situations.

Recognizing this dichotomy, the FDA is seeking input from stakeholders regarding how increased communications from pharmaceutical manufacturers on off-label use could impact the public health. Among other issues, the FDA specifically requests input on the benefits, drawbacks and risks regarding increased communications as it relates to clinical decision making, research, coverage and reimbursement. Also, the FDA seeks input on factors that it should consider in “evaluating whether firms’ communications about unapproved uses of approved/cleared medical products are truthful and non-misleading, including what information firms should disclose in these communications to help ensure audiences are not misled.” The FDA also notes that it is considering “whether revisions are appropriate in order to provide greater legal certainty and clarity to regulated entities.”

In that regard, changes to permitted communications could impact medical malpractice cases. Use of off-label medication is not evidence, in and of itself, of negligence in a medical malpractice case. However, off-label use is often discussed by plaintiffs’ attorneys in trial to take advantage of the public’s misunderstandings regarding off-label use. In a Harris Poll, half of respondents thought that a drug could be prescribed only for its primary FDA-approved use. In turn, half also felt that physicians should be prohibited from prescribing drugs for off-label use. Allowing pharmaceutical manufacturers greater opportunities to promote off-label usage could be a step to de-stigmatize the public’s negative perceptions surrounding off-label use.

Additionally, with communications currently restricted, physicians and attorneys are limited in their ability to establish how others in the field are using FDA approved medicines off-label. By increasing permissible communications, a pharmaceutical manufacturer could sponsor more physician education regarding off-label use of their medications, making it easier to demonstrate a physician was acting in accordance with others in the field.

The potential changes will also impact pharmaceutical manufacturers. If truthful off-label promotion is legal, manufacturers may find relief from potential claims related to unpermitted promotion of off-label use. In the past 10 years there have been at least five settlements of more than a billion dollars, with the FDA and under the False Claims Act, related to off-label promotion. Opening the door to permissible off-label communications could allow much of this previously restricted communication. It would also clarify to drug manufactures the increasingly muddled divide between First Amendment rights and FDA regulations. A recent case involving Amarin Pharmaceuticals, Inc. found that Amarin had First Amendment rights to engage in truthful and non-misleading speech promoting an off-label use of their drug, Vascepa, even though FDA regulations prohibited such speech. By updating its position, the FDA could provide clarity to this divide and provide guidance to manufacturers as to the communications considered to be truthful and non-misleading.

Additional information about the FDA’s request for public comment can be found at For those who do not wish to attend the November hearing, electronic or written comments will also be accepted until January 9, 2017. In the interim, potential changes to the FDA regulations should be considered when negotiating a Corporate Integrity Agreement, which may remain in effect even after new regulations are passed.

We are available to assist with questions that you may have regarding the legal implications of off-label communications or off-label prescribing. Contact your Dinsmore attorney to learn more.