If you work in the pharmaceutical industry, you know that compliance with FDA rules on promotion is crucial to keeping your business in business. A mere allegation of non-compliance from FDA can have a profound impact on business, both directly (e.g., leading to a drop in sales or stock price) and indirectly (e.g., diverting precious resources to work on a response to the letter). In this article we explore recent FDA enforcement trends related to promotion of pharmaceutical products, and discuss the actions you can take to keep your promotion from getting your company the wrong kind of attention.
The myriad of challenges pharmaceutical and biotechnology companies face today include striking a balance between innovation and compliance. Companies must innovate in order to remain competitive, yet remain in compliance with the laws, rules and guidance enforced by multiple agencies that may have differing regulatory goals. While the average patient may believe that drug product innovation is limited only by the intellect and imagination of scientists, the unfortunate reality is that innovation is greatly limited by compliance requirements. Among the challenges the industry faces is regulation by the Food and Drug Administration – including both the approval process and Current Good Manufacturing Practice (cGMP) requirements.
Three critical terms in every compliance and quality assurance team’s vocabulary: validation, qualification and verification. While they may have very similar meanings in the English language and are even used interchangeably at times, when used in the context of the pharmaceutical industry, qualification and verification are a part of process validation not to replace it. This is a very important difference to keep in mind. [Read more...]