FROM THE EDITORS
GE's problems included failure to establish and maintain adequate procedures for validating the device design and also failure to establish and maintain adequate procedures for implementing corrective and preventive actions (CAPA). GE is a large company with significant resources, so how it got to this point may be puzzling.
“Sometimes the agency's agenda is not exclusively driven by what it sees at a particular company, but rather by the industry that the company is in and whether the agency wants to make a statement about compliance within that industry,” says Arthur Levine, a partner with Arnold & Porter in Washington, DC. Levine was formerly deputy general counsel for litigation at FDA and served as FDA's legal adviser on compliance and enforcement matters.
When FDA wants to send a message to industry, he says, the agency identifies an industry leader and assesses its quality programs. “FDA proceeds with a high-visibility enforcement action such as an injunction in order to promote deterrence in that segment of the industry generally.”
The problem is that it is really difficult to decipher how FDA decides which companies it wants to approach to be enjoined, says Levine. Sometimes FDA accepts the enhancement program and corrective actions that you submit to the agency, and the agency is content to monitor the process through further inspections. In other circumstances, however, FDA loses patience with your progress, he says. At that point, it takes a more aggressive step.
“There's very little doubt in my mind that GE Medical Systems responded to FDA's inspectional observations. I have no doubt that the company did take corrective measures and improve its quality systems,” he says. “The fact that FDA has proceeded with an injunction should not be understood by anyone that the company has not been responsive. It's just that the agency for one reason or another has remained not fully satisfied.”
According to Levine, the companies that FDA chooses to focus on, to some extent, are based not just on the inspectional findings but also on higher enforcement priorities about certain industries or industry segments. “FDA's threshold for patience with regard to corrective actions and quality system enhancements is influenced by its enforcement priorities,” he explains. Even if you do everything you believe is reasonable, FDA may have a larger goal.
So, if FDA is sending a message to the entire industry, what measures should you take? “You need to carefully consider the first inspection outcome and try to give a response that is sufficiently engaged. When FDA thinks about an FDA-483 response, it wants a company to respond in a systemic way.”
Some observations lend themselves to a very targeted response, but he says that more often FDA is often looking for a comprehensive response that addresses the system as a whole.
Now more than ever, you need to be extremely diligent in responding to warning letters and you need to make sure that your response is sufficiently comprehensive. Your response must address the root causes of the issues that are of concern to the agency. You must look at the implications of the warning as well as the wording.
Sherrie Conroy for the Editors