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MUSINGS

Sharing Safety: A Patient, and Business, Imperative

Kate Lumpkin

Sharing vital safety information in promotional materials and sales representative presentations isn’t just required by law and regulation, it is an undeniable imperative for both patient and commercial success.

So why is minimizing it, or even omitting it, still the most common violation OPDP cites in enforcement letters? The answer I continue to hear most often is, “we need more room for efficacy claims, even at the expense of sharing the safety information.” Highly successful commercial professionals know better.

Acknowledging the obvious need to share efficacy information, sharing important and understandable safety is the most important aspect of overall commercial success. To maximize its success, it should also be relevant, timely, and integrated deeply into the product’s “story.” Consider the three reasons below:

  1. The patients who take a medical product must fully understand the breadth of the treatment, both the efficacy and the safety, to maximize the benefit and improve their health. Patients who fully understand the benefits AND safety are more likely to stay on the product, thus increasing adherence and compliance. It is critical that they have appropriate knowledge and expectations in order to ensure successful treatment. To provide such is an indication of our authenticity regarding true patient centricity. And as we are in the business of improving patient health, a successfully treated patient is our best advocate for our product.
  2. It is in our business best interest to also boldly share, and consistently reinforce, the safety profile of our products with health care providers – not because we have to, but because doing so creates the best opportunity for commercial success. Health care providers know all treatments may cause adverse events, thus we must share the safety to create credibility. Even more importantly, though, is that we must share the safety to enable appropriate patient selection, create appropriate expectations, and encourage appropriate use. It may take a sales representative 7-12 interactions to influence a health care provider to prescribe a new product, but it will take just a couple of unexpected middle of the night patient complaints to cause the provider to return to a previous treatment regimen. Sharing safety in an honest and transparent way creates win-wins for the patient, the health care provider, and the company’s bottom line.
  3. We must share safety in a way that satisfies today’s legal liability environment, as well as the FDA regulations. When sharing safety, it is vital to consider both the content and the prominence. Here is the link to the FDA draft guidance on safety content and presentation for your reference.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf

There are still many unanswered questions regarding safety presentation, such as patient recall and comprehension in TV ads, ideal amount of necessary information (without also scaring otherwise appropriate patients from even trying the product), and how to best provide the information in various media. Those challenges still need to be addressed and are valid concerns.

However, one thing is certain. Sharing appropriate safety should not be hidden below a sight line, lost in contrast, placed at the bottom of the ad in paragraph form with no header, left by a sales representative until the end of the presentation when it is clear they will not be able to share it, or especially omitted entirely. In addition to sharing appropriate content, it is an imperative to share safety with prominence reasonably comparable to the efficacy presentation.

Ensuring that health care providers and patients know what to expect from their treatment, both the benefits and the safety, is in the best interest of the patient and the best commercial interest of the company. A patient who stops taking a treatment due to unexpected adverse events will never benefit from its efficacy, yielding the worst outcome for everyone.