Source: https://cohenhealthcarelaw.com/2012/12/off-label-drug-promotion-and-marketing-yields-significant-penalties-part-1-amgen-settlement/
Timestamp: 2019-04-18 13:17:49+00:00

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Off-label drug use is not illegal, but off-label drug promotion and marketing can result in significant legal penalties.Most recently, Amgen pled guilty to illegally introducing a misbranded drug, Aranesp, into interstate commerce as part of a global settlement in which Amgen agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of certain drugs.
engaged in false price reporting practices involving several of its drugs.
Companies and businesses that want to promote drugs (such as HCG) for off-label uses should be aware of FDA laws such as misbranding.
The FDA rarely takes enforcement action against physicians, for two reasons: (1) physicians generally operate intrastate in dispensing drugs to their patients subject to state licensing laws, and the FDA traditionally exercises jurisdiction over interstate activities; and (2) the practice of medicine is considered within the purview of state government, pursuant to the Tenth Amendment to the U.S. Constitution.
Thus, off-label administration by the physician to his or her patient is not unlawful. However, the FDA’s argument against Evers was that Evers had “misbranded” the drug “when he publicly advocated” the off-label use, and in so doing, failed to provide “adequate directions” for use as required by Section 502(f)(1) of the FDCA.
The Cohen Healthcare Law Group advises physicians and companies on off-label use legal issues, biotechnology laws, FDA and FTC legal issues in online and brick-and-mortar ventures, telemedicine, Stark and anti-kickback, integrative medicine, and on other business and healthcare legal issues. Contact our FDA legal team today.
[i] FDCA §301(a)(1), 21 U.S.C. §331(a)(1). In addition, inclusion of a non-FDA approved indication on a drug product’s labeling renders that product adulterated, in violation of the FDCA.
[ii] FDCA §301(k), 21 U.S.C. §331(k).
[iii] U.S. v. Evers, 643 F.2d 1043 (1981).
John E. Obsorn, Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information, 10 Yale J. Health Pol’y, L. & Ethics 299 (2010).
[iv] The experience of Purdue Pharma, manufacturer of the prescription pain medication OxyContin, illustrates the perils of misbranding and other violations of the FDCA. The company was accused of encouraging physicians to prescribe OxyContin for use every eight hours instead of the twelve-hour dosage approved by the FDA. It eventually agreed to pay 19.5 million dollars to twenty-six states and the District of Columbia to settle a civil suit based on its alleged promotion of off-label use of the painkiller. However, Purdue Pharma suffered an even more serious blow when the U.S. Department of Justice brought criminal charges against the company and three of its top executives. Federal prosecutors contended that Purdue Pharma had engaged in a fraudulent and deceptive marketing campaign that falsely claimed that OxyContin, because of its timed-release formula, was more resistant to abuse and less likely to cause addiction than competing products such as Percocet. The federal government also charged some company sales representatives with giving doctors misleading scientific data to support their fraudulent claims. Three company executives also pleaded guilty to misdemeanor charges of misbranding OxyContin, a violation of the FDCA that does not require proof that the defendants intended to defraud doctors or consumers or that they knew about the wrongdoing of others. These officials agreed to pay a total of $ 34.5 million in fines. Purdue Pharma illustrates that pharmaceutical companies and their executive officers who violate FDA regulations by promoting off-label uses run the risk of incurring huge fines or even incarceration if they are caught.
See Department of Justice, Otsuka to Pay More than $4 Million to Resolve off-label Marketing Allegations Involving Abilify(March 27, 2008).
[vi] U.S. Department of Justice, Pharmaceutical Company Cephalon to Pay $425 Million for Off-Label Drug Marketing(September 29, 2008).
[vii] U.S. Department of justice, Pharmaceutical Company Eli Lilly to Pay Record $1.415 Billion for Off-Label Drug Marketing (January 15, 2009).
[viii] U.S. Department of Justice, Allergen Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox® (September1, 2010).

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