The past several months have brought forth numerous bits of news, pronouncements, expressions of concern and general uncertainty about the device regulatory regime, but also about FDA’s regulatory paradigm in general.  The recent piece in the New York Times regarding disagreement about the diabetes drug Avandia and the controversy involving accusations of conflict of interest by CDER head Janet Woodcock in the consideration of competing applications for enoxaperin, in the wake of last year’s resignation of Dan Schultz at CDER has led many to wonder where FDA is going under Dr. Margaret Hamburg.

Clearly, the new leadership at FDA is now acutely aware of the number and scale of the issues confronting FDA.  In their overwhelming majority, the scientists and technical specialists at FDA are dedicated and committed individuals.  At the higher levels, however, FDA has suffered from a series of problems, none more troubling in its long-term implications for the future of the industries it regulates, than its absence of imagination.

The FDA’s approach to science is rooted in statistical models, and those models and the people who analyze their results are wholly unwilling (as a matter of culture) to do finely tuned, meaningful risk-benefit analysis.  Several years ago, FDA’s own internal assessment cautioned that this blind reliance on statistical analysis will render it entirely incapable of assessing a new generation of complex devices, medications and combinations. The FDA is earning a reputation for inability to approve a product either safely or accurately, because it evaluates products in a statistical vacuum, without regard to societal benefit, need or even real-world safety variables.

There is some hope to be found in the fact that CDRH recently admitted that it needed new methods and new thinking, precisely along these lines.  That represents a refreshing start, but it will only make a difference if it is inculcated in FDA’s culture as a whole. Dr. Hamburg has quite a challenge ahead of her.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

In a recent FDA presentation Foster City, CA, Mark Roh, Regional Food and Drug Director outlined the most common cited 483 items for both pharma and med device companies:

The most common Drug GMP FDA-483 (observational) items:

• Responsibilities and procedures of the Quality Control unit are not in writing
• Written procedures are not followed
• Control procedures not established
• Inadequate specificatons
• inadequate written procedures
• Inadequate failure analysis

The most common Medical Device GMP FDA-483 (observational) items:

• Deficiencies in complaint file system
• Inadequate CAPA procedures
• Lack of written MDR procedures
• Corrective and preventive actions not documented
• Inadequate process validation

This doesn’t mean you won’t be cited for anything not listed in the bullet items or nabbed for all of the above. These are the most common observations cited by FDA personnel during an inspection. So now you may want to go back and take a good hard look at your SOPs, quality management system, CAPA process, complaint handling/MDRs as well as your validation documentation. Obviously training your personnel in these procedures and processes is also key.

Of course, everyone’s goal is not to end up here…

Also, you may want to check out our previous blog entry “Don’t Ignore 483s…it’s in Your Best Interest to Respond in Writing“

The concept of implementing SaaS is moving ahead quickly, especially in the medical device arena. Perhaps that shouldn’t be surprising; most industry experts say that device firms tend to be a bit more innovative when it comes to embracing new technologies.

That may be why Angiotech made the decision to go with AssurX’s OnDemand (SaaS) model as opposed to on-premise implementation for their global complaint handling system. Angiotech is a global specialty pharmaceutical and medical device company that discovers, develops, and markets innovative technologies and medical products primarily for local diseases or for complications associated with medical device implants, surgical interventions and acute injury.

AssurX’s CATSWeb system is already rolled out across four facilities – three in the US and one in Puerto Rico – with Europe expected by the end of 2009.

Larry Murphy, Senior Manager, Corporate Quality, was part of the team that made the decision to go with the SaaS model because they needed to get up and running quicker.

“We got the blessing of the IT group after they reviewed the AssurX system and were able to get answers quickly about the level of security and support,” Murphy said. “As far as the users are concerned, they really like having everything centralized, including the reporting capabilities. We have significantly improved our efficiency and productivity,” added Murphy.

Prior to implementing an automated complaint handling system, various divisions of Angiotech were using either paper-based systems or homegrown Access database applications. Now the company-wide system using CATSWeb allows them to process complaints in a more structured and standardized manner that provides a much higher level of quality of information as well as the ability to track progress using metrics and dashboards.

Future plans include expansion of the current process and perhaps implementing electronic medical device reporting (eMDR) somewhere down the line.