Truthful off-label marketing protected as free-speech

August 11, 2015

Blog Post

In a free-speech decision that could cause a seismic shift in the pharmaceutical market, a federal judge in New York last week ruled that the First Amendment protects truthful off-label marketing of FDA-approved drugs.

Federal law allows a doctor to prescribe FDA-approved drugs for any purpose the doctor deems medically necessary, even if the drug is not approved for that purpose. This process is called an “off-label use”. Even though a doctor can prescribe for off-label use, the federal Food, Drug and Cosmetic Act prohibits a drug manufacturer from marketing the drug for off-label use.

Recently, the FDA, the Department of Justice, state attorney’s general, and the whistleblower community have become increasingly aggressive in going after drug companies and individual drug representatives for promoting off-label use. As The New York Times reported:

“Over the last few years, the government reached major criminal and civil settlements with GlaxoSmithKline ($3 billion), Abbott Laboratories ($1.5 billion), Merck ($950 million) and Amgen ($762 million) related to off-label promotions of their products.”

As explained in a 2014 HHS publication, the Government believes off-label marketing leads to medically unnecessary or inappropriate treatment and over-utilization of certain drugs. HHS also identified concerns over “deceptive practices that promoted off-label uses of many prescription drugs.”

This could all be changing. In a landmark decision, U.S. District Judge Paul A. Engelmayer ruled that the First Amendment protects off-label marketing, so long as the statements are truthful and not deceptive. The Government likely will appeal to the U.S. Court of Appeals for the Second Circuit, which in a 2012 case held that the First Amendment requires a narrow reading of the ban on off-label marketing.

If this decision stands, pharmaceutical companies will see tremendous opportunities to expand their product markets without the risk of Government sanctions.

Over the past 24 months, the U.S. Department of Health and Human Services Office for Civil Rights has brought notable enforcement efforts against several non-profit covered entities and business associates, resulting in instances of six and seven-figure penalties against providers across the county for incidents involving breaches of protected health information.

A new amendment to New York state law, which would have required all healthcare providers to obtain separate consents from patients for treatment and payment is on hold until further guidance is released, according to the New York Department of Health.

On November 1, 2024, the Centers for Medicare & Medicaid Services issued the Medicare Physician Fee Schedule 2025 final rule, which establishes new advanced primary care management billing codes that will expand opportunities for physician practices, federally qualified health centers, rural health clinics and other health care providers to get paid for services provided by clinical staff under the direction of a physician, nurse practitioner or physician assistant beginning January 1, 2025.

Truthful off-label marketing protected as free-speech

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