Since my first post in this series, the FDA has issued two more warning letters regarding data integrity to drug manufacturers. As I stated in part one, 79% of warning letters to drug manufacturers in 2016 were related to data integrity – a number we’ll likely see rise this year if these new warning letters are any indication.
In part one of this series, I laid out a basic understanding of data integrity, including how it creates trust between a drug or medical device manufacturer and the FDA. In this post, I’m taking a brief look at how losing that trust can and will impact your business.
Impacts of Poor Data Integrity
In examining the history of enforcement trends, companies with data integrity issues have difficulty recovering. With data collected, analyzed, and exchanged at a near constant rate, there’s an almost equally constant opportunity for a data integrity problem to propagate and derail more than your compliance standing.
In early 2015, the FDA took API producer Polydrug Laboratories to task following an in-depth inspection, citing them for failing to record or investigate quality-related customer complaints, for production deviations and inadequate controls on computerized systems. Later that year, the FDA banned imports from the India-based drug manufacturing plant. Needless to say, this kind of import ban can all but destroy profitability for any business but even more so in the increasingly competitive pharma landscape.
In a similar and even more recent event, the FDA issued a Form 483 to Indian API manufacturer Divi’s Laboratories in early December 2016. The 5 observations included references to severe data integrity issues, including “manipulated data records.”
The observations were escalated just a few weeks ago when the FDA issued an import alert on several products from the impacted facility. Furthermore, the fallout from the regulatory action resulted Divi’s stock falling 22% – the largest one-day drop in the company’s history, showing that the ramifications of data integrity issues also threaten shareholder and consumer confidence.
Though quality practices and technologies have evolved, the FDA continues to cite primary quality functions in inspections. With an increase in budget and greater focus on data integrity for the FDA, life sciences organizations must ensure compliance of their basic functions to address emerging challenges.
Here, I’ve outlined just a few examples of how seemingly manageable data integrity issues can quickly spiral to create true, strategic challenges that aren’t so easily overcome. Have you seen similar issues becoming just as unwieldy? Join the conversation on one of our social channels (LinkedIn, Twitter, Facebook) and let us know!
And don’t forget – check back in or subscribe to our insights below for part 3 of this series on data integrity where we’ll explore tips, tricks, and best practices for overcoming data integrity challenges.