Off-Label Marketing

What is off-label marketing?

“Off-label marketing” refers to the practice of marketing health care products for uses that have not been determined to be “safe and effective” by the FDA. Under some circumstances, Medicare and Medicaid will not pay for medications that are prescribed for uses that have not been FDA-approved.

Many of the recent, large scale False Claims Act settlements with drug manufacturers involve schemes in which the companies marketed their products for uses that had not been determined to be “safe and effective” by the Food & Drug Administration (FDA).

Drug manufacturers are prohibited by federal law from marketing drugs for non-FDA-approved indications. (21 U.S.C. § 331; 21 C.F.R. § 312.7.) Medicare, Medicaid and other government health care programs generally do not pay for medications that are prescribed for a use that has not been approved by the FDA, and, accordingly, is not a medically accepted use. (42 U.S.C. § 1395y(a); 42 U.S.C. § 1396r-8(d)(1)(B), (k)(3) and (6); 42 C.F.R. § 411.15(k); Medicare Benefit Policy Manual, Pub. 100-02, Ch. 16, § 20, Ch. 15, § 50.4.1.)

This sort of use is referred to as “off-label,” as it is a use that is not endorsed on the medication’s FDA-approved product label. While physicians may prescribe medication off-label without violating their medical licenses, it is generally illegal for anyone to knowingly bill a government health care program for an off-label use. When drug manufacturers market their medications for off-label uses they consequently not only violate the rules of the FDA, they also may violate the False Claims Act by causing doctors to prescribe, and pharmacies to bill Medicare and Medicaid for off-label use of their drugs.

When a pharmaceutical company markets its drug off-label, the following factors, among others, are relevant to whether the U.S. Department of Justice will take enforcement action under the False Claims Act:

  1. The dollar value of the off-label use paid for by Medicare and Medicaid;
  2. The strength of the documentary proof and other evidence of the off-label marketing;
  3. Whether the off-label marketing rose to the level of a consistent company practice;
  4. The strength of the evidence that the company’s marketing “caused” off-label prescriptions either by directly influencing doctors or creating a medical consensus that indirectly influenced doctors;
  5. Evidence of lack of safety or efficacy of the off-label use, such as a “black box warning” on the product label, FDA denial of an application to approve the use, results in clinical trials, or specific incidents of harm; and,
  6. The relative cost of alternative, on-label treatments for patients.

VSG Qui Tam Lawyers Are Experienced in Handling Pharmaceutical Off-label Fraud Cases

VSG represented a sales manager who brought a whistleblower action against his employer, the pharmaceutical manufacturer Wyeth, for off-label marketing of the drug Rapamune.  This case, in conjunction with another case with partially overlapping allegations, led to a recovery of $491 million for the Government.  The firm’s client has used his whistleblower award to fund the creation and operation of a retreat in rural Arkansas for ministers and other spiritual leaders.

 

 

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