More than ten years ago, I wrote an article about a company action that invoked a memory of my then-3-year old son’s playful “The Thinker” pose. (I continue to have this picture hanging in my office now.) He would frequently say, “Hmmm.” I have always wanted to find a Part II story for my now-ten-year old daughter to avoid any sibling rivalry. The time has come.
The Food and Drug Administration recently issued a Warning Letter to a pharmaceutical company, where the company delayed and then impeded a facility inspection. Here’s the bottom line: If FDA has the authority to inspect a manufacturing facility, it is a prohibited act to delay or limit the inspection. While the Federal Food, Drug, and Cosmetic Act describes when, where, and what the agency can and cannot inspect, as a basic rule when a company produces goods regulated by FDA, the agency can inspect and, with some exceptions, it has significant access to information maintained at the facility.
The facts of the case at issue are amusing.
- In April 2016, FDA contacted the company, located outside the United States, to arrange an inspection.
- Almost two months later, but nine days before the planned inspection, the company responded that the factory workers and staff went on strike. FDA cancelled the pre-announced inspection.
- A month later and then a few weeks after that, the company repeated this strike excuse, even showing a photograph of striking employees and the facility entrance blocked.
- Despite the apparent strike, FDA learned that the company manufactured a number of products during that time.
- FDA wrote in its Warning Letter:
Your false statements to FDA regarding the purported strike at your facility delayed FDA’s scheduling and conducting of a pre-announced inspection.
- Six months later, FDA eventually conducted its inspection. However, the agency noted in the Warning Letter:
Your firm’s actions during this inspection significantly hindered FDA from fully assessing your compliance with CGMP [current Good Manufacturing Practices]. For example, doors to the … vessel room and packaging and labeling storage areas were locked, impeding reasonable access for the investigator to these areas, and limiting this inspection….
- Among the many violations cited in the Warning Letter, FDA included that the drugs were “adulterated,” because the products were made in a facility where the owner delayed and limited the inspection.
- The facts of the case are highly unusual, and the company’s actions were certainly ill-advised.
- There are limits to FDA’s inspectional authority, about which we have written and spoken numerous times in the past. However, if the agency has the right to inspect a facility, and the requests for information are within FDA’s inspection authority, the company cannot deny or limit an inspection. Period.
- While it is understandable that many companies would prefer not to have FDA visit – as this is not a milk and cookies visit — FDA has an obligation to protect the public health and conducting inspections is a means to accomplishing this objective. And, the agency has this legal authority.
- It is important for a company to know its rights, but it is equally important to respect and recognize FDA’s power.
- While there is no legal obligation to roll out a red carpet for FDA, providing false information, locking doors, promising (but not delivering) agency-requested information, and leaving investigators in the dark (literally) is disrespectful, discourteous and, well, unlawful. Things that make you go hmmm.