What the Gulf Oil Spill Has to Do With Drug Safety

At the time of this writing, inspectors from the Food and Drug Administration (FDA) are at work monitoring seafood safety in areas affected by the oil spill in the Gulf of Mexico. Finger-pointing continues and there is now talk on the news of criminal prosecutions. The full economic effect of the disaster is not yet known—the oil spill remains a top headline and will no doubt be in the news for months to come, if not years.

If history is any indication, a tragic event of this proportion will renew the public’s appetite for government oversight and regulation. This would likely be the case even if the FDA were not so directly involved in cleaning up the mess—literally and figuratively. But in this case, the sea change at large in our society (no pun intended), is a front-of-mind issue in FDA halls. Nobody at the FDA should be expected to now make excuses for aggressive oversight of quality operations—whether in food processing plants or pharmaceutical manufacturing operations. The public is rightfully outraged.

Even before this unfortunate incident in the Gulf of Mexico, FDA administrators were grappling with a report by the U.S. Government Accountability Office (GAO), issued on Jan. 29, entitled, “Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal Misconduct Investigations.” The GAO report, while noting FDA successes in criminal prosecutions, also spelled out blatant areas where improvements were needed.

In responding to Congress, FDA officials concurred that improved communication methods were required for better enforcement (which will also reap sorely needed revenues from fines and restitutions gained with better enforcement). FDA officials have also stated their intent to increase the use of misdemeanor prosecutions against corporate officials. In this same report to Congress the FDA announced its intent to enhance its debarment and disqualifications, now publicly reported, to tighten oversight of clinical investigations.

One also needs to factor in that the recent passage of health insurance reform means more oversight of every entity in the health care industry—hospitals, device manufacturers, pharmaceutical processors, etc. It defies logic to think that more public funding for health care will give FDA-regulated companies more free reign.

Be prepared. For example, if your company hasn’t formalized standard operating procedures to deal with FDA 483 Letters there is no better time to do so than now. See the white paper on Form 483 Letters, “Guide for US FDA-Regulated Organizations -- How to Respond to (and Avoid) Form 483 Letters for Temperature, Humidity and Other Controlled Environments.”

All this might seem like a bitter pill to many hard-pressed quality assurance managers already trying to keep up with voluminous paperwork that regulations require, but considering it from a layman’s perspective, if FDA regulations are perceived by the public as being a way to take lead-free toys, dangerous pills, or diseased food off their worry list, then regulation is a good thing. Granted, this is a pendulum that swings back and forth—but from where we sit now it would be foolish for any organization to spend energy fighting oversight and regulation. Rather, making wiser decisions on how to maintain full compliance and product safety at the lowest costs should be the paramount concern.

The good news, especially in the pharmaceutical industry, is that there is a concomitant trend to factor in risk and overall cost-of-goods-sold strictly from a competitive economic standpoint. Many of the major players in the industry now have ample data—even before this growing public appetite for more oversight—of the economic toll that corrective and preventive action (CAPA) investigations can take on the company’s bottom line. It’s really quite simple—all the energy that a life science company devotes to CAPA concerns are taking resources away from new product development, marketing, etc., that help gain market share and profits.

There are nascent trends affecting how companies are now approaching environmental monitoring solutions in the life science industry. For instance, basic decisions on whether to go wireless or maintain the traditional Ethernet wired network seem to be shifting. Many are now looking at using the tried-and-true reliability of their existing wired Ethernet as preferable. With wireless communications so subject to interference, all are now insisting that any wireless configuration have data redundancy to ensure gap-free records (i.e., a hybrid system that combines stand-alone data collection with centralized monitoring and alarming). This platform ensures the ability to record at the point of measurement in the event of wireless network failures but also to back-fill data into a continuous record when wireless networks are restored. See the white paper on monitoring systems, “Monitoring Systems, You Can Have It All.”

Yes, there is increased public appetite for more FDA scrutiny of operations. At the same time, there is more sophistication among quality managers in discerning costs of ownership vs. upfront costs of the many technologies and instruments they use to ensure quality standards. Competition in the global marketplace is greater, and that is an even bigger driver of how to use technology to minimize operation costs—due to product loss, downtime, and failed quality audits—throughout the long term.

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