11 Indest-2008-8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two whistleblowers brought suit against Pfizer’s Wyeth Pharmaceutical Inc. (Wyeth) alleging violations of the False Claims Act (FCA).  Relator Lauren Kieff alleged the company encouraged physicians to prescribe its acid reflux drug, Protonix, off-label.  This is in addition to allegations that Wyeth offered Protonix in oral and intravenous forms as a bundling deal to offer both drugs at a discount to physicians and hospitals.  This same deal was reportedly not offered to Medicare and Medicaid thereby overcharging the government programs by not paying an alleged hundreds of millions of dollars in rebates due to them.

Wyeth told a Massachusetts federal court on Thursday, November 12, 2015, that a whistleblower cannot prove that the company encouraged physicians to prescribe Protonix off-label.  Wyeth argued that it would be near impossible to determine causation acknowledging a plethora of outside resources physicians could have relied on including their own independent judgment in deciding to prescribe the drug off-label.

However, Kieff claims that Wyeth’s own internal records show that physicians gained much of their knowledge on Protonix IV through the pharmaceutical company’s sales representatives.  Furthermore, she points out that there have been no clinical studies about off-label uses of Protonix for physicians to rely upon.

To read the full complaint of the United States, click here.

Off-Label Prescribing.

Physicians can generally prescribe drugs off-label.  However, off-label use of drugs previously approved by the Food and Drug Administration (FDA) for a certain medical condition is not regulated and is considered “experimental” or “investigative.”  The FDA does not regulate the practice of medicine.  Therefore once the FDA has approved the drug, physicians are free to use their professional judgment in prescribing the drug.

For more information on off-label prescribing, click here.

Due to the risks involved in off-label prescribing, most insurance companies are reluctant to reimburse such prescriptions since its use may be entirely ineffective in treating the patient or even detrimental.

Off-Label Promotion of Drugs by Pharmacies.

The promotion of utilizing drugs off-label constitutes a violation of the FCA when it results in billing to a government health care program such as Medicaid and Medicare.  State programs explicitly prohibit coverage for off-label prescription usage.  The theory behind this prohibition is that using a drug in a way it has not been medically accepted (or approved by the FDA) results in waste of government funds on assumed ineffective treatments.

Centers for Medicare and Medicaid Services issued some guidelines for recognizing the various forms of unlawful off-label promotion, to include:

(1)    Paying incentives to sales representatives based on sales for off-label use;

(2)    Paying kickbacks to physicians to prescribe drugs for off-label use;

(3)    Disseminating misleading posters promoting off-label use;

(4)    Paying physicians:

(a)    To pretend to be the authors of articles about off-label uses when the articles were actually written by manufacturers’ agents;

(b)    To serve as members of “advisory boards” promoting off-label use;

(c)    To travel to resort locations to listen to promotions about off-label use; or

(d)    To give promotional lectures in favor of off-label use to fellow practitioners;

(5)    Providing advice to prescribers on how to code their claims and document their medical records to support payment for off-label uses not covered by Medicaid;

(6)    Publicizing studies showing efficacy of off-label uses while suppressing studies showing no efficacy; and

(7)    Making false representations directly to Medicaid to influence decisions about payment for drugs used off-label.

To read more about off-label pharmaceutical marketing, click here.


Are you facing allegations of off-label promotion?  Do you suspect your company may be involved in the unlawful promotion of off-label prescribing?
Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.


American Cancer Society.  “Off-Label Drug Use.”  Cancer.Org.: 17 Mar. 2015.  Web.  19 Nov. 2015.

Centers for Medicare and Medicaid Services.  “Off-Label Pharmaceutical Marketing: How to Recognize and Report It.”  Fact Sheet: Oct. 2015.  Web.  20 Nov. 2015.

Kass, Dani.  “Wyeth Rejects Claim That it Promoted Off-Label Prescribing.”  Law360.  Portfolio Media Inc.: 13 Nov. 2015.  Web.  16 Nov. 2015.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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