I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems worse than its bite nowadays.  The Pink Sheet had an article written by Joanne Eglovitch (here, paid subscription required) entitled “The Quality Lowdown: US FDA Finding New Crop Of Data Integrity Problems” today that stirred me up again!

The article noted two firms that had actual data integrity issues, as well as, firms that have had serious repeat cGMP violations related to audit tracing in their computer systems and bad cGMP practices.  Because of the serious nature of these violations and the fact that they were repeat observations, one of the foreign firms cited decided not to market its product in the US any longer.  Great for the US consumers, but what about the consumers in ex-US markets?  For them, maybe not so good.  But be aware, DI issues are also occurring at domestic drug manufacturers and laboratories.

Data integrity is the key quality measure.  Without DI, firms are only making their best guess or just ignoring quality altogether.  Harken back to the generic drug scandal days and the FDA’s Application Integrity Policy (AIP) which had real teeth to stop data integrity in its tracks.  Firms were shut down and applications that contained fraudulent data were withdrawn by the Agency.  Somewhere between then and now, the FDA got nervous and thought that the API or their fraud policy might not hold up in court. They also used the debarment process, which is still in effect, but it does not seem to be used that often to punish firms or individuals for data integrity lapses, or outright fraud today.

I know the arguments, that it is difficult to enforce US laws against foreign entities; worry about court overturning FDA policy; worry about creating drug shortages by placing draconian measures on firms for cheating or fraud or repeat egregious cGMP violations, and on and on. FDA still has some tools like Import Alerts, but that does not get to the root of the problem because, like one of the firms mentioned in the Pink Sheet article, they just stop selling in the US market!

I don’t want to get on a sustained rant today, I am sure with the COVID-19 pandemic, the current unrest and protests in the US over race relations and police misconduct, as well as the political divide, you have heard enough rants to last you a lifetime.  I will just leave you with this one thought: data integrity can be avoided by having senior leadership aware and ready to “nip it in the bud” or even better, by preventing it by developing an excellent quality culture in the company.  It all starts from the top. For information on what you can do to help instill that quality culture at your firm, please call or email Lachman Consultants to assure you are on the right track.