Fierce's 2012 Top 10 FDA Red Flags

By Eric Palmer

Executives of drug manufacturers will tell you their companies intend to meet all of the FDA's current good manufacturing practices. Actually, their bottom lines dictate that they should. Companies that don't do this lose sales and brand loyalty, and sometimes have to make unplanned and very large investments in consultants and plant upgrades. Plant closings can lead to shortages and shortages can lead to a whole host of other problems, like Congress looking for answers when they hear from constituents who face the prospect of death because the best treatments are unavailable.

In the last few years, we have had very public examples of all of this. Novartis ($NVS) and Johnson & Johnson ($JNJ) collectively recalled millions of products, catching black eyes while losing revenue, an estimated $1.5 billion in J&J's case. Production interruptions at plants owned by Boehringer Ingelheim, Hospira ($HSP) and Sandoz have led to drug shortages that have been all over the media and made legislators very angry and anxious to legislate in the U.S. and Canada. On the flip side, when the FDA misses something and safety or quality issues affect the public, like when heparin contamination led to patient deaths some years back, then it pays the price as well.

Sometimes there are mitigating factors. If you close down an aging plant that happens to be the sole supplier of crucial drugs, who will pick up the slack? And some of those plants have gone too long before getting that upgrade because the margins on the generics they produce are so slim that boards don't want to authorize investments.

Still, at any given time, there are companies here and around the world that stumble and the FDA catches them. FDA warning letters and 483 inspection forms certainly do not tell the whole story about who is and who isn't doing the best job in drug and API manufacturing. But they are the red flags for the industry, indicators of where the agency is headed when it comes to plant inspections.

So what are the most significant warnings and citations to happen in the last 12 months? That is hard to say. We at FiercePharmaManufacturing selected the 10 in this report for a number of reasons. Some of them, like the problems that led to plant closures or serious production interruptions at Novartis and the Ben Venue Laboratories plants, have had an impact both deep and wide. Some were selected because they represent potential trends in the way the FDA is approaching its duties, like citations for unprotected data systems, and the three-plant sweep the agency made along the Merck Serono supply chain. Some illustrate the legal consequences of not addressing problems fast enough.

Once you read the report, if you have ideas about others you think should be included, let us know by posting comments or sending email. -- Eric Palmer (email | Twitter)