Blog

Federal Court Rules FDA Can't Restrict Off-Label Marketing by Drug Makers

Photo of Eric Gerard

Top 10 posts.jpg

In a landmark ruling of enormous potential significance but, for now at least, questionable applicability nationwide, a federal district court in New York has held that the Food and Drug Administration (FDA) cannot restrict drug makers' efforts to market pharmaceuticals for indications not approved by the agency. While doctors are permitted to prescribe drugs for non-FDA-approved (or "off-label") uses, drug manufacturers themselves have long been prohibited from marketing their products off-label on the theory that such promotion could harm consumers. Patients, the reasoning behind the ban held, might be swayed by advertising into pressing their doctors for prescriptions to treat maladies where there was little scientific evidence supporting the effectiveness and safety of such uses.

On August 7, 2015, however, a federal district court judge sitting in Manhattan ruled that the federal government could not proscribe off-label marketing, citing the First Amendment as the basis of his decision. While misleading commercial speech may generally be barred by the government, truthful commercial speech enjoys greater protection. The court held that off-label marketing constitutes protected commercial speech so long as it is truthful and not misleading.

The implications of this decision are sizable. For years, pharmaceutical companies have faced the specter of heavy government fines for marketing off-label, while the False Claims Act authorized "whistleblowers" within the industry to bring private civil claims (called qui tam actions) for violating the ban. Should off-label marketing be accepted as legal, such enforcement actions and private causes of action will disappear. Consumers are those most likely to suffer, given that drug makers will lose the incentive to seek rigorous scientific support for product uses in soliciting FDA approval. Instead, they will be permitted to bring drugs to market and promote them through billion-dollar ad campaigns so long as those ads are "not misleading"-a far lower bar than the FDA approval process demands.

At present, the trial court's decision is of limited effect, constituting dispositive law only in the case to which it applies and persuasive authority in other matters even within the same jurisdiction. The precedent on which it was based, however, is a Second Circuit decision that had vacated the conviction of a pharma sales representative who was prosecuted for violating the FDA's ban on off-label promotion. There, the appellate court extended the First Amendment's protection of truthful advertising to off-label marketing in the criminal context, which the district court judge above applied in a civil matter. It thus appears likely that, in the Second Circuit at least, a sea change has occurred. Whether courts elsewhere agree remains to be seen.

The lawyers at Abraham, Watkins, Nichols, Sorrels, Agosto & Friend have been protecting the rights of consumers and patients for over 65 years. If you or someone you know has been harmed by a defective product or dangerous drug, please call us today at 713-222-7211 or toll free at 1-800-870-9584.

No Comments

Leave a comment
Comment Information

Awards & Recognition

  • 2016-2017 Equal Access to Justice Champion

    The Equal Access to Justice Champions Program was started by the Houston Bar Association in 2006, to help ensure placement of Houston Volunteer Lawyers cases with pro bono volunteers. Originally, firms were tiered according to size, and firms within each tier committed to accept a certain number of pro bono cases from HVL each year for five years.

  • The National Trial Lawyers | Top 100 Trial Lawyers

    The National Trial Lawyers: Top 100 is an invitation-only organization composed of the premier trial lawyers from each state or region who meet stringent qualifications as civil plaintiff and/or criminal defense trial lawyers. Selection is based on a thorough multi-phase objective and uniformly applied process which includes peer nominations combined with third-party research.

  • Million Dollar Advocates Forum

    Established in 1993, the Million Dollar Advocates Forum (which includes the Multi-Million Dollar Advocates Forum) is one of the most prestigious groups of trial lawyers in the United States. Membership is limited to attorneys who have won million and multi-million dollar verdicts and settlements. There are over 4000 members throughout the country. Fewer than 1% of U.S. lawyers are members.

  • Recognized by Best Lawyers America | Abraham, Watkins, Nichols, Sorrels, Agosto & Aziz | 2017

    Recognition by Best Lawyers is based entirely on peer review. Their methodology is designed to capture, as accurately as possible, the consensus opinion of leading lawyers about the professional abilities of their colleagues within the same geographical area and legal practice area.

  • Lead Counsel Rated

    In order to earn the Lead Counsel Rating, an attorney must not only demonstrate significant legal experience, but must also receive multiple peer recommendations advocating his or her ability. This is a key component in the screening process.

  • Texas Super Lawyers | Texas Monthly

    Each year, Super Lawyers recognizes the top lawyers in Texas via a patented multiphase selection process involving peer nomination, independent research and peer evaluation. The Texas lawyers who receive the highest point totals during this selection process are further recognized in Texas Super Lawyers Top Lists.

Get Your Free Case Review 713.587.9668

Let Us Help You Today! Request a Free Consultation

Bold labels are required.

Contact Information
disclaimer.

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.

close

Privacy Policy

  • $50+ Million Personal Injury Fire and Explosion

    The firm successfully represented nearly 100 victims who suffered personal injuries and damages to property from a large fire and explosion resulting in a settlement of more than $50 million. The firm served as lead lawyers on the steering committee in this litigation.

  • $80 Million Personal Injury Large Plant Explosion

    The firm successfully represented 270 plaintiffs', taking a lead role in the plaintiffs' steering committee, who suffered injuries in a large plant explosion resulting in a settlement of nearly $80 million.

  • $50+ Million Personal Injury Plant Fire and Explosion

    The firm successfully represented 45 personal injury victims in a plant fire and explosion, serving on the plaintiffs' steering committee, concluding with a settlement of more than $50 million.

  • $22+ Million Personal Injury Work Site Accident

    The firm prevailed in a personal injury trial for a worksite injury client with the jury returning a verdict and resulting in a judgment of over $22 million for the firm's client.

  • $12 Million Auto Accident 18-Wheeler Collision

    The firm successfully achieved a $12 million settlement for the family of a man who died in an 18 wheeler collision.

  • $30 Million Personal Injury Burn Victims

    The firm prevailed on behalf of three burn victims with settlements totaling nearly $30 million.

Our Record Of Success.

When you are hurt and you choose a law firm to represent you in court or at the negotiation table, you need to carefully consider the firm's record.

More Success Stories