Just when you think that the FDA has to stick to the script by quoting chapter and verse of CGMPs, they get very progressive and offer straight talk about corporate commitment and leadership.

We have reported before that the FDA expects corporate oversight of the Quality Management System. (The QA Pharm 4/17/11.) The Johnson & Johnson debacle is just one recent example where the FDA cited the corporate folks for taking their eye off McNeil where Tylenol is manufactured.

But the Warning Letter to PolyCarbon Industries recently posted on the FDA website has an added dimension—a call for commitment and leadership. The Warning Letter dated December 2, 2010, reads as follows:

“It is essential that your firm establish and maintain a corporate commitment to an effective pharmaceutical quality system. Your firm’s management should demonstrate leadership and ultimate responsibility by participating in the design, implementation, and monitoring for quality throughout the company. Management should establish policies that describes your firm’s overall approach to ensuring drug quality and communicates your expectation of compliance with all requirements of applicable federal law and FDA regulations.”

There’s a lot of insight packed into this paragraph. The most important aspect is what commitment and leadership behaviors look like from an FDA perspective.

So, let’s do a little behavior analysis:

1.    Does your corporate group participate in the design, implementation and monitoring of quality at your company?

The best example of this that I have seen was a corporate group that facilitated a focused discussion of internal and external experts that led to the creation and deployment of company compliance policies.

The worst example was a company that hired a consultant to write the corporate policies. The policies appeared one day on the company intranet with the edict that they be deployed within six months. The old “right click on properties” revealed that the consultant had used the same policies for another client. The only thing different was the logo.

2.    Does your corporate group establish and communicate policies regarding regulations and compliance requirements?

The best example of this that I have seen was a company that deployed the policies with the business message that compliance was important to patients and the ability to compete. Compliance was to be valued and the operating norm.

The worst example was a company that couched the compliance message in terms of FDA inspections getting tougher, and that—right or wrong—the bar was being raised. “We just have to face reality.”

Regulatory compliance is no different than any other area of the company that requires commitment and leadership. Frankly speaking, when there is little leadership in this area, I find little leadership in other areas too.

So to our friends at the FDA, I say: “Spot on.”

Sometimes what needs to be said can’t be referenced to the Code of Federal Regulations, but is truly at the heart of the problem.