With the total revenue of the worldwide pharmaceutical industry fast approaching one trillion dollars, the pressure of capturing valuable market share is forcing companies to spend more and more money on advertising. Pharmaceutical companies spent a total of $4.5 billion last year, an 18% increase from 2013, on TV commercials, magazine ads, websites, social media and much more to promote their products. Compounding the growth of the industry with the growth of digital media, promotional materials for pharmaceutical products can be found everywhere.
Due to the risks present with prescription drugs, the Food & Drug Administration (FDA) has put strict regulations & guidance on the labeling and promotion of pharmaceutical drugs. The FDA’s Office of Prescription Drug Promotion (OPDP) continually monitors promotional materials that have been released to the public to ensure that it does not inaccurately portray the risks, dosage amounts, intended use or directions. If the OPDP identifies an infraction, they issue Warning letters or Untitled letters to the company at fault. These letters must be taken very seriously, and besides being extremely costly, the corrective actions are neither easy nor quick.
The number of letters that the FDA issues are likely to increase in the coming years as companies struggle to track their promotional materials in various medias. Therefore, it is extremely important that pharmaceutical companies have a robust process in place that can easily track where all promotional materials are located and the information they contain.
One of the top 10 global pharmaceutical companies recently received an Untitled letter from the OPDP and requested BlueLine Associates’ help in defining their current state for creating & tracking promotional materials. After multiple Kaizen events & Voice of the Customer sessions, BlueLine identified serious gaps in their process, and recommended seven improvements to ensure that all the possible root causes for inaccurate material being read by a patient were addressed. These recommendations are currently being implemented to ensure that the organization can track every promotional piece and identify the content it contains to a single keyword.
In the past 5 years, pharmaceutical companies have paid over 13 billion dollars to resolve allegations by the US Department of Justice regarding marketing practices. It is extremely costly and dangerous to release promotional materials with misinformation, so it is very important for pharmaceutical companies to have proper processes in place to create and track the promotional materials released to the public.