Truthful, Not Misleading Marketing Of Off-Label Drugs

In a landmark ruling, Amarin Corp. received approval to provide doctors with information about the unapproved uses of their fish-oil pill.  Promoting off-label use could have led to misbranding charges; however, the federal judge ruling allows the pharmaceutical industry to provide information to doctors about using medications that are not already approved by the Food and Drug Administration (FDA) as long as the information is ‘truthful and not misleading’.

As discussed in “Ruling Lets Drugmaker Promote Use Without FDA,” posted by Anna Edney on, doctors are allowed to prescribe drugs ‘off-label’ – not as explicitly described on the drugmakers’ label.  However, drugmakers are not allowed to promote their drugs for any other use other than what was approved by the FDA.  Amarin produces a prescription-grade, omega-3 pill that is approved to treat high triglycerides and wanted to share information about a trial study involving the use of their omega-3 for patients with moderately elevated triglycerides.  However, the FDA threatened to charge Amarin with misbranding if they discussed this off-label use.  Amarin claimed that the FDA was preventing them from “engaging in constitutionally protected truthful speech” and the court agreed.  The results of this ruling essentially allow pharmaceutical businesses to provide information about the unapproved uses of their drugs, even without a request.

Although drugmakers can now offer ‘truthful and non-misleading’ statements about the off-label uses of their drugs, they could still be called to the table to back up these statements.  Pharmaceutical businesses that utilize enterprise resource planning (ERP) solutions, such as Microsoft Dynamics® AX, can respond quickly to doctor or FDA requests for information.  This robust ERP solution offers a Quality Document Management Portal, electronic batch records, enhanced audit trails, and electronic signatures as well as built-in support for cGMP, HACCP, ISO, and other compliance regulations and traceability features.  You can be confident in the quality of your data and use the built-in reporting features to prepare and share reports that can support your off-label claims (as long as they are truthful and non-misleading).

Drugmakers can use a modern business solution to capture, analyze, and share the data pertaining to products and services.  Contact AKA Enterprise Solutions for more information about the ERP solution that can support your strategic business goals.

By | 2018-07-06T17:46:21+00:00 August 31st, 2015|Compliance, Data|0 Comments
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