|15th June 2017
The 21st Century Cures Act was signed into law last December during the Obama administration. It brings numerous changes to the US drug development landscape, impacting patients, academia, research institutions, and industry. Over the last number of months Blue Latitude have been engaging with US pharma companies to help our clients understand its implications and how it could be leveraged.
In this article, I will focus on the sections of the Act that relate specifically to communication around approved medical products and the impact it could have on the industry. Specifically, I will discuss the changes to medical product communications and how the FDA evaluates promotional materials that present information not contained in the labelling for the product. I believe this will increase collaboration between pharma and analytics.
The context for this change in policy is rooted in the evolution of healthcare from a volume to a value based market. For years, the priorities of drug development programmes were to prove the safety and efficacy of a drug in a placebo controlled, double-blind clinical trial that would support application for marketing authorisation. These studies did not take into account the measures of performance requested today around value, such as rate of hospitalisation, cost per quality-added-life-year or patient reported outcomes, as these measures were not a prerequisite at time of trial design.
Data illustrating the value of a drug is in high demand today, but repeating completed studies would incur substantial costs the industry is simply not willing/able to incur. Luckily, a lot of this data already exists. It exists in health records, patient registries, and claims databases, which, while uncontrolled, provide a huge sample set. Enter the 21st Century Cures Act – which opens up credible sources of Real World Evidence (RWE) for commercial use to understand and communicate the value of medical products.
To be very clear, this is not a yard sale on data! There is still significant rigour required when using RWE commercially and adherence to the product prescribing information is critical. The FDA released guidance to add more detail on this matter. In it, the agency acknowledges that “labelling is the primary tool for communicating essential information needed for safe and effective use of the product ... it is not intended to be an exhaustive summary of all that is known about the product for its approved or clear uses.”
To support industry in determining whether communications about a product are consistent with the product’s FDA-required labelling, a three-factor system has been outlined. If a communication fails to satisfy any one of these factors, it is not consistent with the labelling.
Factor 1: Does the information in the communication compare to information about those conditions in the FDA-required labelling? (The answer to all must be yes)
|11th December 2018
Blue Latitude Health sits down with key opinion leader and specialist neurologist Dr Timothy Vollmer to better understand the paradigm shift in MS treatment. He explains the challenges neurologists face when making treatment decisions, and why patients need to be treated with more efficacious drugs earlier on.
|10th December 2018
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging markets.
|3rd December 2018
Multi-award-winning advocate and patient engagement champion Trishna Bharadia gives a valuable insight into life with multiple sclerosis. She explains how treatment has changed, how our healthcare systems and pharma can unite to improve quality of life for MS patients today, and why her diagnosis isn’t stopping her achieving her goals.