Can the FDA Live up to its Promise of a Risk-Based Approach to Compliance?

Published on: 
BioPharm International, BioPharm International-03-01-2008, Volume 21, Issue 3
Pages: 40–45

The expanding globalization of the industry poses a challenge for international enforcement.

In 2002, the USFood and Drug Administration decided to take a risk-based approach to inspections. Now, five years after announcing this approach, it's time to ask: how is the FDA progressing with this initiative?

Warren Perry

The quick answer is: so-so. Although the agency is doing a satisfactory job implementing a risk-based approach in the pharmaceutical, biotech, and devices industries today, troubling red flags in other sectors raise serious concerns, particularly as all industries become globalized.


China clearly is the biggest thorn in the FDA's side. In 2007, there were major recalls of pet food products in the US, followed by recall of toothpaste manufactured in China. According to industry experts, China's large and mostly fragmented food-processing industry makes inspection extremely challenging. And currently, China and many other Asian countries lack the supply chain infrastructure to support a risk-based system. As a result, the possibility for similar problems in the future is very high.

And the risk that similar problems—with much more dire consequences—could occur with pharmaceutical ingredients or products imported from China or other countries is real. The US and Chinese regulatory authorities entered into a cooperative agreement last fall, but that is only the beginning of what needs to be done.


Unfortunately, there is no easy solution. The FDA is relying on programs that are based heavily on technology solutions and require a complete, verifiable chain of custody. This chain of custody requires electronic records to support quality and facilitate recalls. This will not work for countries like China and India because technological infrastructure and risk-based manufacturing principles do not exist there. If the agency is serious about implementing risk-based enforcement of its regulations across all industries it oversees in the US and abroad, the following needs to happen:

  • A two-tiered solution: The FDA should institute a certification program for manufacturers of food and drugs that contains certain requirements based on technology, workflow processes, and sound GMPs. Companies meeting these requirements would fall into one tier that would be scrutinized less than the second tier of companies that do not meet these requirements. Companies perhaps could also receive some type of financial incentives to motivate them to improve and join the first tier. Over time, a system similar to the one in the US, where companies are ranked based upon their track record, could be put in place. Of course, this will require consistency among vendors and the ability to track who is who.

  • Better foreign inspection processes: The FDA needs to set up arrangements so that it can regularly inspect foreign manufacturers before problems arise. Such a system already exists in countries like France and Germany, where US inspectors can visit factories and issue warnings if there are problems. This is not the case in countries like China and Russia, because the political implications are much too high.

  • Political buy-in: Until countries start working together in a truly global fashion, consistently enforceable regulation will not be possible. Funding and financial incentives must be put in place. This, of course, will require transparency on all levels, which some countries may be unwilling to agree to.

These are three seemingly simple parts of a bigger solution, but they could potentially have far-reaching effects. Until the FDA and the US Congress seek to seriously address some or all of these ideas, we most likely will be looking at more pet food and toothpaste recalls, and maybe something much worse.

Warren Perry is a compliance advisor at QUMAS, Jersey City, NJ, 973.805.8642,