Regulations and compliance are part of life. On a macro level, the Constitution regulates some of the fundamental responsibilities and protections of our government and of all Americans. On a more mundane level, traffic laws regulate how we drive. Regulation and oversight are a bit like the old adage of the chicken and the egg – which came first? New or expanded federal, state and local agencies, such as the Consumer Financial Protection Bureau, receive mandates to monitor a particular aspect of life or business. To meet their mandate, they establish regulations, a compliance investigative arm and repercussions for failing to comply. Governments also pass new laws, such as the Affordable Care Act, and out of necessity a bureaucracy develops or expands to oversee those laws.
In an industry such as healthcare, adherence to regulations helps ensure quality care, patient safety and informed patients and providers. Pharma, in particular, must comply with drug marketing regulations that are intended to avoid messaging that may over-sell the benefits and outcomes of medications. Nonadherence to these regulations may negatively impact both an organization’s bottom line and its reputation.
A costly outcome of misleading marketing
Genentech, a popularized member of the Roche Group, and OSI Pharmaceuticals is a case in point. In June of this year, Genentech and OSI agreed to settle claims that they misled physicians about the effectiveness of Tarceva® in treating newly diagnosed lung cancer patients. The U.S. Food and Drug Administration (FDA) approved Tarceva as a second-line treatment and data shows that it is most effective for patients with non-small cell lung cancer who had never smoked and for those with the epidermal growth factor receptor (EGFR) genetic mutation. Investigators were able to show that from 2004 to 2010 Genentech and OSI developed marketing materials and had interactions with physicians that were misleading and suggested a broader prescribing opportunity. The settlement came under the False Claims Act (FCA), which was enacted by Congress in 1863 in response to concerns that businesses were defrauding the Army during the Civil War. The Genentech/OSI case is the first time cancer-drug survival data has been used as evidence to prove false claims. Genentech and OSI agreed to pay $67 million — a costly penalty for the lack of internal oversight of marketing materials and direct interactions with physicians.
The yin and yang of marketing
Creating marketing language that is at once both accurate and compelling can be challenging. Persuasive language can easily become boastful spin if not carefully scrutinized. It is critically important for a pharma marketing team to build its promotions on solid data and information that supports the claims being made.
MannKind Corporation, the maker of Afrezza®, is discovering this yin and yang of marketing since Sanofi, a French pharmaceutical company, announced in January it was returning marketing rights for Afrezza, an inhaled insulin, to MannKind. Titration and spirometry issues are at the heart of Sanofi’s decision to give up its marketing rights.
Developing a sales force that can keep this medication in the treatment arsenal for providers who care for patients with diabetes is the responsibility of Michael Castagna, chief commercial officer at MannKind. Castagna believes that MannKind can present the benefits of the drug to providers who are able to:
- Perform spirometry in their offices to test lung capacity in patients being considered for inhaled insulin
- Titrate the medication to patients’ individual needs
Patient safety is at risk if the sales force ignores these critical elements in marketing materials and fails to present off-the-shelf purchasing options for providers who do not have spirometry equipment. A strong, straight-forward marketing campaign to relaunch Afrezza addresses provider capabilities, focuses on the importance of spirometry and titration, and educates providers so they can, in turn, educate their patients.
What are your biggest concerns when it comes to pharma sales/marketing compliance? Tweet @MMITnetwork to have a conversation and check back later this week for Perspectives on Pharmaceutical Drug Compliance: Part 2.