Truthful Off-Label Speech and Misbranding: The Claim Still Has to Match the Science

Truthful off-label promotion has First Amendment protection in the Second Circuit when it concerns a lawful use of a drug approved by the Food and Drug Administration and is non-misleading. Amarin later obtained protection for specified communications about Vascepa. For someone in medical affairs or sales, the important questions are what the company said, what supported it and how the prescriptions became claims for government payment.

What Is Considered Off-Label Promotion?

Off-label promotion is a manufacturer’s promotion of a drug for a use outside the labeling approved by the Food and Drug Administration. A physician may prescribe an approved drug for an unapproved use. The manufacturer operates under a separate set of rules governing how it markets the product and what use it intends for it.

The approved product is specific: its indication, strength, dosage form and route of administration belong to the approval. The approval question concerns the use the agency reviewed. The promotion question concerns the use the company is trying to sell. The payment question concerns the use a health care program will cover.

The distinction reaches the business model. In its account of Warner-Lambert’s Neurontin promotion, the Justice Department reported that the company chose not to seek approval for new uses because approval could allow generic competitors to use those indications against a planned successor product. The reason for leaving a use off the label was commercial. An insider’s understanding of the approval strategy can explain something the promotional material alone cannot.

How Off-Label Promotion Became Misbranding

The historical misbranding theory turned on intended use and labeling. It could reach a promotional statement without requiring the government to prove that the statement was false.

Under the historical approach to the Food, Drug, and Cosmetic Act, a prescription drug needed approved labeling covering the uses the company advertised. Promoting another use supplied evidence that the manufacturer intended the drug for a purpose its approved label did not cover.

That was the mismatch: the company was selling a use it could not put on the approved label. The government could pursue that mismatch even without a false scientific claim. The company’s decision to speak became the central issue, and the later speech decisions narrowed that approach.

Truthful Off-Label Promotion and the First Amendment

Truthful off-label promotion received First Amendment protection in the Second Circuit’s December 2012 opinion. The protection concerns a lawful use of an approved drug and a truthful, non-misleading message.

That puts the content of the message at the center of the question. False or misleading claims remain subject to enforcement, and payments to induce prescribing raise a separate question. For an insider, the useful comparison is between what the study found and what the company told prescribers it found.

Amarin and the Vascepa Promotion Dispute

Amarin obtained preliminary court protection for specified truthful, non-misleading communications about an off-label use of Vascepa. The Food and Drug Administration had declined to approve the additional use Amarin sought, and the company asked the court to decide what it could say about it.

The Southern District of New York’s August 2015 decision applied the Second Circuit’s reasoning to Amarin’s proposed statements and accompanying disclosures. The words and the qualifications traveled together. Public Citizen’s account of the dispute reports that a March 2016 settlement allowed Amarin to promote Vascepa for the off-label use.

For a medical affairs employee, the distinction is concrete: the claim and the information accompanying it have to be considered together. We work with you on the comparison between the company’s message, its scientific support and what the audience actually received.

What Changed in the Intended-Use Rule in 2021?

The intended-use amendment effective September 1, 2021 says a firm’s knowledge that healthcare providers prescribe or use an approved drug off-label, by itself, does not establish that the firm intends an unapproved new use.

The earlier rule said that a manufacturer which knew, or had notice, that its drug would be used for other purposes had to provide adequate labeling for those uses. The amended rule separates knowledge of prescribing from the company’s own intended use.

Promotional communications and the circumstances in which a product is offered still matter to intended use. The amendment addresses the inference drawn from knowledge alone.

When the Sales Claim Outruns the Study

A promotional claim can mislead by attributing a finding to a study that did not measure it. The allegations against Shire give that problem a concrete form.

Shire agreed to a $56.5 million civil settlement announced in September 2014 over alleged improper marketing and promotion affecting prescriptions and program reimbursement. In a whistleblower’s complaint, the alleged Adderall XR pitch was that it was superior to competing drugs at normalizing children with ADHD. The complaint challenged what the study could actually support:

The alleged mismatch was specific: a comparative sales claim rested on a non-comparative study. A scientific citation gave the pitch an appearance of support while the complaint alleged that the study answered a different question.

The same complaint alleged that sales representatives and medical science liaisons promoted Vyvanse as non-abuseable despite a supporting study that concluded it could be abused. It also alleged that Adderall XR promotional material failed to prominently display important abuse warnings. The scientific paper, the sales message and the risk information supplied to the physician belonged in the same comparison.

These allegations show why an employee’s knowledge of the underlying study matters. The difference may be visible to the person who knows what the investigators measured and what the commercial team said they measured.

Government Payment Raises a Different Question

A False Claims Act case examines the connection to government money. For drug promotion, that includes the claim submitted for payment, the use it represented and the company’s role in causing a false claim.

Medicaid’s definition of a medically accepted indication includes FDA-approved uses and uses supported by qualifying citations in recognized drug compendia. These reference works therefore matter to reimbursement alongside the approved label. When a company knowingly causes a false claim for a use the program does not cover, taxpayers pay for the prescription.

Payments introduce another issue. The Anti-Kickback Statute addresses payments made to induce prescribing or other covered business, and resulting claims can support a False Claims Act case. Speaker selection by prescribing volume, a fee for an event that never happened, or an internal calculation tying payments to prescriptions concerns what the company bought. The accuracy of a slide does not answer that question.

Those are different records inside the same business. Scientific staff may understand the claim’s support. Sales staff may understand how a speaker was selected. Reimbursement staff may understand what a payer was told. We connect those accounts to the payments and prescriptions they concern.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

What the Later Enforcement Shows

Later civil cases continued to connect drug promotion to allegedly false claims. Celgene agreed to a $280 million civil settlement announced in July 2017 concerning alleged promotion of Thalomid and Revlimid for unapproved uses and resulting false claims. The alleged link to false payment claims is what makes this a civil whistleblower example after the speech decisions.

Public Citizen’s 2018 report, Twenty-Seven Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017, found that federal financial penalties for unlawful promotion had declined sharply after 2013. It questioned whether the change demonstrated improved company compliance. On the separate question of whistleblower activity, it said:

A fall in penalties is a poor substitute for evidence that the sales pitch became more honest.

When You Know What the Study Actually Said

If you know where a drug’s sales message departed from its scientific support, or how promotion fed government reimbursement, speak with our whistleblower experts about that connection. We stay beside you throughout the process, building your strongest whistleblower case from the company’s science, communications and payment decisions and bringing in pharmaceutical fraud whistleblower lawyers who understand both promotion and reimbursement.