http://www.bulletproofblog.com The blog on crisis communications Fri, 30 Jul 2010 17:06:27 +0000 http://wordpress.org/?v=2.8.4 en hourly 1 http://www.bulletproofblog.com/2010/05/17/what%e2%80%99s-next-the-bulletproof-interview-%e2%80%93-david-sterling-and-jane-griffith-on-food-safety/ http://www.bulletproofblog.com/2010/05/17/what%e2%80%99s-next-the-bulletproof-interview-%e2%80%93-david-sterling-and-jane-griffith-on-food-safety/#comments Mon, 17 May 2010 12:09:13 +0000 Larry Smith http://www.bulletproofblog.com/?p=2797 Each week, Bulletproof Blog™ features exclusive interviews with thought leaders on issues of critical importance to companies and countries. This week, with recent recalls of deli meats, lettuce, and ground beef keeping food safety issues top of mind for the U.S. consumer, we interview David Sterling and Jane Griffith, two of the nation’s foremost experts on food and beverage supply chains and their impact on the integrity of the food we eat.

David Sterling, a partner with Sterling Solutions, has more than 25 years experience in finance and supply chain management from both a consulting and industry perspective. Jane Griffith, the Director of Quality Assurance and Food Safety for Wawa, Inc., leads a team that is responsible for food safety and product quality throughout the supply chain – from vendor selection, certification and management to execution of foodservice programs at the store level.

Mr. Sterling and Ms. Griffith shared their insights with Bulletproof™:

Last year, an American Society for Quality study found that more Americans are worried about food safety than the War on Terror. What’s driving this level of anxiety? How can food and beverage companies best calm the fear?

David Sterling and Jane Griffith: One of the primary reasons for increased consumer concern over food safety is the recent uptick in recalls in the U.S.  These recalls have impacted many different product categories and illustrate the scope of the food network. Most important, they have demonstrated how one ingredient can compromise the safety of many products and food processors. In addition, the increase in consumer awareness on food safety issues stems from the number of product lots affected during each recall, which raises consumers’ worries that their families may have eaten contaminated food, believing it was wholesome. Finally, the media attention to this subject, both on the national news and in the movie theatres (with the release of Food, Inc., Fast Food Nation, and Supersize Me), has dramatically impacted consumer perceptions of the food industry.

While the War on Terror is a major concern to all of us, many Americans are not directly impacted by it. Meanwhile, food directly impacts every American each day. As public awareness of food safety issues has increased, the potential that it can personally impact anyone of us at almost any time is a reality that consumers understand. In addition, at one time or another, almost all consumers have experienced purchasing food that, at a minimum, had compromised quality issues due to poor handling. The enormous scale and reach of the food chain in the U.S., coupled with the fact that most consumers possess at least at some level of understanding regarding food safety risks, creates a setting in which consumer concern can grow.

Ensuring safe food is a complex, intense, holistic process that touches all aspects of production – from raw ingredient growing practices and harvesting to processing, packaging and shipping. The food ingredient can be compromised at any stage along the food chain and this can lead to a recall. At the same time, most consumers are unaware of the processes that industry has implemented to ensure safe food via continuous oversight and monitoring of the food system from farm to fork.

In what specific ways are food and beverage companies changing their practices to reflect the public’s concern over food safety? How would you recommend that the industry publicize those measures?

David Sterling and Jane Griffith: The food industry, and especially retailers and Quick Service Restaurants (QSRs), are facing a loss of consumer trust by providing education on their practices to ensure food quality and safety. These may be posters in the establishment committing the retailer to providing safe food or a news story in a local paper. This is a very sensitive issue and some companies are reluctant to claim that they are providing safe food 100 percent of the time because they understand that nothing is certain and they don’t want to mislead consumers and further erode their trust.

The food industry and trade organizations are partnering with the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and the Food Safety Inspection Service (FSIS) to improve recall response and attention to food safety issues. Our foremost goal is reducing the time between discovery of a safety issue and communication of that issue to the public. Most important, we want to ensure that the product or ingredient being recalled is truly the source of an outbreak. We saw numerous examples of a poor recalls with the tomato, lettuce, and jalapeño pepper recalls of 2007. During those recalls, the FDA was not able to determine the true source of the outbreak and recalled several different commodities throughout a period of weeks. That caused an unnecessary economic impact to the food producers, suppliers, and the food industry as a whole. It also created consumer distrust because they lost confidence in government and industry and felt that we didn’t want to tell the consumer where the true problem really was.
               
Other initiatives underway within the food industry include an increased emphasis on the cold chain, or the distribution and logistics associated with getting perishable products on the shelves.  Improvements in technology are enabling companies to monitor product temperatures throughout the cold chain. In addition, advances in nanotechnology will allow food pathogens to be detected as the product moves through the cold chain. Finally, improved cold chain processes that will work with advancing technology are currently being developed. At the same time, training, education, and operational improvements are areas of focus to improve distribution processes not impacted by improved technology.

What issues are emerging on the horizon that all food and beverage companies need to know about?

David Sterling and Jane Griffith: One of next emerging issues associated with food safety is the traceability of a product from the source to the retailer. This level of detail will help to provide comfort to customers concerned about the origin of a product. It will also help with narrowing down recalls so that only impacted products are removed from sale and not the entire commodity or lot code.

Another emerging issue is the increased emphasis on food distributors and logistics providers.  Standards have long been targeted for harvesters, suppliers, and, more recently, retailers. The development of standards for food logistics providers is on the horizon. By ensuring that these food chain participants are held to appropriate standards, best practices will be in place for almost all of the participants within the food chain.

Click here to receive the Bulletproof Interview in your inbox each week.

Larry Smith is Senior Vice President of Levick Strategic Communications, the nation's top crisis communications firm, and a contributing author to Bulletproof Blog. Connect with Levick on Twitter: @Levick.

]]> http://www.bulletproofblog.com/2010/05/17/what%e2%80%99s-next-the-bulletproof-interview-%e2%80%93-david-sterling-and-jane-griffith-on-food-safety/feed/ 0 http://www.bulletproofblog.com/2010/03/29/what%e2%80%99s-next-the-bulletproof-interview-%e2%80%93-robert-maples-on-the-fda%e2%80%99s-transparency-initiative/ http://www.bulletproofblog.com/2010/03/29/what%e2%80%99s-next-the-bulletproof-interview-%e2%80%93-robert-maples-on-the-fda%e2%80%99s-transparency-initiative/#comments Mon, 29 Mar 2010 12:59:26 +0000 Larry Smith http://www.bulletproofblog.com/?p=2362 Each week, Bulletproof Blog™ features exclusive interviews with thought leaders on issues of critical importance to companies and countries. This week, as the Food and Drug Administration (FDA) enters the final phase of its new Transparency Initiative, we interview Robert Maples, a Senior Legislative Advisor at the law firm of Dickstein Shapiro LLP, about the FDA’s effort to make the agency – and the companies it regulates – more open to the general public.

Mr. Maples has counseled a number of clients and companies on complex regulatory and public policy matters. Currently, he leads the Research Accountability Project (RAP), which aims to identify, disclose, and prevent socially-biased agency-based government research. A leading authority on food, drug and tobacco issues, and editor of the e-newsletter FDATracker®, Mr. Maples shared his thoughts with Bulletproof™:

Tell us about the FDA’s Transparency Initiative and its intended impact on the companies it regulates. Are there regulatory changes in the offing that food and pharmaceutical companies should be preparing for now?

Robert Maples: On his first full day, President Obama issued an Executive Order on transparency and the FDA’s Transparency Initiative arose in response to this call for open government. The FDA formed a Transparency Task Force; built FDA Basics; held two public forums for input; and is currently reviewing approximately 1,400 comments to a public docket.

I‘ll also disclose a secret: Sources tell me that FDA has done all the work to date on a very modest budget and their effort is being watched as a potential model for other federal agency transparency efforts.

I don’t foresee any great regulatory changes emerging from this effort. There may be continuing debate and potential further restrictions and regulation of corporate social media utilization and the transparency of what is disclosed. As Justice Brandeis so famously said, “Sunlight is the best disinfectant” – and, for the most part, what is to be “disinfected” has yet to be seen.

What tangible benefits await food and pharmaceutical companies that take a more transparent approach when communicating with key marketplace and government stakeholder groups?

Robert Maples: I had an old friend in the public relations business whose advice in crisis situations was to “tell the truth and tell it often.” I don’t think any readers doubt that we have a new FDA on the watch and the message is clear: Police thyself and do it well or a warning letter is in your future. Further, FDA has signaled an interest in “stepped-up” criminal enforcement, which probably keeps many a CEO up at night.

Companies that police themselves and walk the white line will find enormous benefit by not being the next front page story in the Wall Street Journal. Transparency is a significant element in effective reputation management – and today, reputation management is really, really important to FDA-regulated companies.

Furthermore, in the wake of a year that was as tough on the consumer product industry as I can remember, I think that consumers want a little more connection to the brands they buy. Information and communication will reinforce the brand connection with the consumers and empower them to be confident in their buying decisions.

Are there ways that food and pharmaceutical companies can leverage the power of online communications to enhance transparency?

Robert Maples: Yes, many have used online communication to provide consumers additional information regarding products, adverse reactions, and precautions. The Web provides a very cost-effective and open forum to provide expansive information that can’t fit on a box, label, or bottle. Of course, FDA is watching the Web as well, so my advice to companies is to communicate with an eye toward compliance.

What’s next at the FDA? Are there issues emerging on the horizon that the companies under its purview need to know about?

Robert Maples: Almost all aspects of old existing authorities are seeing many new initiatives.  The Senate is poised to pass food safety modernization legislation and the food companies ought to be thinking about how they can shape its implementation. The Drug industry faces multiple challenges – from generics to nanotechnology and beyond. And, then, there is tobacco. The FDA is literally building a new enterprise to regulate the $80 billion U.S. tobacco market with 370 new personnel next year.

Click here to receive the Bulletproof Interview in your inbox each week.

Larry Smith is Senior Vice President of Levick Strategic Communications, the nation's top crisis communications firm, and a contributing author to Bulletproof Blog. Connect with Levick on Twitter: @Levick.

]]> http://www.bulletproofblog.com/2010/03/29/what%e2%80%99s-next-the-bulletproof-interview-%e2%80%93-robert-maples-on-the-fda%e2%80%99s-transparency-initiative/feed/ 0 http://www.bulletproofblog.com/2010/03/11/latest-food-safety-recall-turns-attention-toward-legislative-remedies/ http://www.bulletproofblog.com/2010/03/11/latest-food-safety-recall-turns-attention-toward-legislative-remedies/#comments Thu, 11 Mar 2010 18:56:47 +0000 Gene Grabowski http://www.bulletproofblog.com/?p=2282 salmonella has been detected in a popular flavor enhancer used in products ranging from hot dogs and salad dressing to potato chips and soup. Signs of contamination were also detected at the Basic Food Flavors plant, which made the hydrolyzed vegetable protein in question. Given the scope and sheer number of food products that contain the flavor enhancer, some experts are predicting that we may be on the cusp of the biggest food recall in FDA's 100-year history.

Coming on the heels of high-profile recalls of pistachios, cookie dough, peanut butter, tomatoes, spinach, and a host of other food products, this latest food safety recall is also spurring renewed calls for Congress to step in and finally update food safety legislation that has remained largely unchanged since 1906, despite modifications in the 1930s and 1970s. Last year, Senator Dick Durbin (D – Ill.) sponsored a bill that would change all that. And with each major food recall only increasing the chances that the Durbin bill could become law, smart food companies ought to begin preparing now to do business in what soon could become a more rigid regulatory environment.

Should the Durbin bill pass, the FDA will evolve from a largely reactive agency to one focused primarily on prevention. Among other measures, the proposed legislation seeks to require food manufacturers to perform analyses that identify where contamination is most likely to happen and develop risk mitigation plans that clearly outline how the company will reduce the chances that an outbreak could occur. The bill also seeks to ensure that onsite FDA inspections occur more often than the current industry average of around once every 10.5 years and provide the FDA with the authority to mandate recalls for the first time in the agency’s history.

With such sweeping changes now a real possibility, companies that act now to demonstrate their focus on prevention will not only ready themselves to meet tougher compliance standards. They will also position themselves as industry leaders at a time when only 32 percent of Americans are “very confident” that the food they buy is safe.

Gene Grabowski is Senior Vice President of Crisis and Litigation at Levick Strategic Communications, the nation’s top crisis communications firm. He is also a contributing author to Bulletproof Blog. Connect with him @crisisguru.

]]> http://www.bulletproofblog.com/2010/03/11/latest-food-safety-recall-turns-attention-toward-legislative-remedies/feed/ 0 http://www.bulletproofblog.com/2009/11/17/big-pharma-stuck-on-the-sideline-of-the-digital-revolution/ http://www.bulletproofblog.com/2009/11/17/big-pharma-stuck-on-the-sideline-of-the-digital-revolution/#comments Tue, 17 Nov 2009 21:25:35 +0000 David Bartlett http://www.bulletproofblog.com/?p=1356 brand-decisive impact, it seems that just about every company in every sector of the economy has taken to the online space, implementing digital strategies at varying levels of sophistication. Amid all the corporate blogs, Twitter accounts, and Facebook pages, however, one industry remains noticeably absent.

Big pharmaceutical companies have been reticent to embrace the online space as a primary marketing and communications tool – and for good reason considering the lack of total brand control; fear of violating uncertain Federal Drug Administration (FDA) regulations; and concerns about failing to spot and then disclose an adverse effect reported to an obscure blog, Twitter account, or Facebook page (and thus opening themselves to criminal and civil litigation).

At the same time, the FDA’s recent two-day discussion entitled “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media” drew well over 800 attendance requests. That suggests Big Pharma must know it’s missing a huge opportunity to communicate as long as it is on the digital sidelines.

The Internet-related issues that industry and regulators must sort through are as arcane as they are numerous. For example, there’s the questions of how best to ensure that Google Adwords campaigns articulate detailed disclaimer language (something that simply isn’t possible now, given a character limit that makes a Twitter post seem verbose). Even more fundamentally, how do we even define what actually constitutes “online advertising?”

To complicate matters, the industry likely won’t be receiving FDA guidance on what’s permissible in the online space until sometime in 2011. With innovations in digital communication coming fast and furious, the issues discussed today could be moot by the time word comes down from on high.

For the time being, Big Pharma’s cautious approach to digital and social media is appropriate, given the legal and reputational liabilities that could arise in an environment where no one knows what’s acceptable and what’s taboo. Right now, the best the industry can do is precisely what it has been doing – ensuring itself a seat at the table when the online rules are written and preparing for the day when it too can fully employ the world’s most powerful messaging vehicles without fear of regulatory ire.

]]> http://www.bulletproofblog.com/2009/11/17/big-pharma-stuck-on-the-sideline-of-the-digital-revolution/feed/ 0 http://www.bulletproofblog.com/2009/08/17/pharmaceutical-companies-and-a-google-adwords-dilemma/ http://www.bulletproofblog.com/2009/08/17/pharmaceutical-companies-and-a-google-adwords-dilemma/#comments Mon, 17 Aug 2009 17:28:08 +0000 David Bartlett http://www.bulletproofblog.com/?p=484 sent letters to 14 pharmaceutical companies warning them that failing to include risk information in Google adwords postings could lead to trouble. As anyone who' s ever googled "acid reflux," "high cholesterol," or "hypertension" probably knows, there is simply no way to fit that kind of detailed information into the 70-character space that Google provides - even if the fine print could be made even finer.

So, what is the pharmaceutical industry to do? It certainly can' t turn its back on search engine advertising. It can' t mess with FDA-approved disclaimer language. Expanding the size of Google adword postings is not an option.

A few creative solutions have emerged, such as the use of "redirect URLs" that hide the fact that viewers of a Google ad will be directed to a branded pharmaceutical site. Some Google drug ads even omit the name of the drug or the condition it is intended to treat. But these are likely to be just short terms solutions, as it is probably only a matter of time before a consumer-oriented FDA calls out those practices for lacking transparency as well.

The regulations that now govern direct-to-consumer drug advertising have evolved over many years and reflect many compromises between drug companies and regulators. Unfortunately for all concerned, the growing importance of online advertising is rapidly rendering those regulations out of place in the real world.

That being said, there is still no easy solution. Trying to enforce yesterday' s print and broadcast regulations in today' s online world is a waste of time. Ignoring the fact that Google ads are too brief to include the kind of wordy disclaimer that the FDA would prefer is plain silly. Abandoning oversight of online drug advertising could be dangerous.

In order to avoid a regulatory battle that would make regulators look foolish and leave drug companies without an increasingly valuable advertising vehicle, the two sides need to sit down and work out a reasonable and realistic compromise that reflects the realities of the digital age.

If regulators are willing to recognize that the world is changing, and if drug companies are willing to be reasonable in their dealings with their powerful FDA overseers, consumers will benefit. And that, after all, is what both sides should be most concerned about.

David Bartlett is a Senior Vice President at Levick Strategic Communications, an expert communications strategist and crisis manager, and a contributing author to Bulletproof Blog.]]> http://www.bulletproofblog.com/2009/08/17/pharmaceutical-companies-and-a-google-adwords-dilemma/feed/ 0 http://www.bulletproofblog.com/2009/08/17/what%e2%80%99s-next-the-bulletproof-interview-%e2%80%93-mike-rozembajgier-of-stericycle%e2%80%99s-expert-recall-team-on-a-new-era-of-recall-regulation/ http://www.bulletproofblog.com/2009/08/17/what%e2%80%99s-next-the-bulletproof-interview-%e2%80%93-mike-rozembajgier-of-stericycle%e2%80%99s-expert-recall-team-on-a-new-era-of-recall-regulation/#comments Mon, 17 Aug 2009 14:15:14 +0000 Larry Smith http://www.bulletproofblog.com/?p=482 exclusive interviews with thought leaders on issues of critical importance to companies and countries. This week, as a follow up to our discussion of the Consumer Product Safety Improvement Act (CPSIA) with former Consumer Product Safety Commission compliance chief David Schmeltzer, we check back in with Mike Rozembajgier of Stericyclce' s Expert RECALL team.

Mr. Rozembajgier has helped hundreds of companies navigate the complex logistical, compliance, and communications challenges of more than 1,400 product recalls. A nationally-recognized expert in product safety crises and how the CPSIA is now significantly impacting the regulatory landscape, he shared his insights with Bulletproofâ„¢:

With strict new CPSIA recall standards in effect, what must companies be doing now to ensure they' ll be in compliance should a recall situation arise?

Mike Rozembajgier: Preparation has always been paramount in conducting effective recalls. Now that the strict new standards set forth in the CPSIA have taken effect, having a solid plan in place before a recall situation arises is absolutely essential. Has your recall team been assembled and do the members know their responsibilities? Have they come together to build the organizational trust that fast action demands? Are systems in place to collect the retrieval and outreach data that regulators will now be demanding? Has your supply chain been audited backwards and forwards?

These are the questions that every consumer product company needed to start asking themselves from the moment that the CPSIA passed. Now, if the answer to any of them is no, then you' re really behind the eight ball.

How have the ways in which companies must communicate with consumers, regulators, legislators, shareholders, and other stakeholders changed as a result of the new CPSIA standards?

Mike Rozembajgier: Consumers, retailers, and supply chain members need to hear clear, concise messages about the problems that led to the recall, the remedies being taken to ensure that the public is protected, and what the company is doing to prevent a similar occurrence in the future.

When it comes to regulators and legislators, they are going to want to know that the recall itself has been effective. That means having ready access to the hard data that demonstrates results. From proving that all affected products came off the shelves quickly to showing that your outreach efforts kept the public informed, the numbers are your strongest ally. Again, that comes back to planning. It' s about being ready to collect information about the recall from the minute it begins.

What' s next with regard to recall regulation? Are there issues emerging that consumer product companies need to be aware of?

Mike Rozembajgier: First of all, don' t expect the government' s focus on consumer safety to lose intensity. With Congress already discussing further legislative action and the White House firmly behind those efforts, the hoops that companies must jump through to ensure compliance are only going to multiply.

And second, we' re probably going to see the plaintiffs' bar leveraging any perceived misstep into big-dollar cases. Again, this means companies are going to have to be armed with the data that proves they acted in a responsible manner.

Larry Smith is Senior Vice President of Levick Strategic Communications and a contributing author to Bulletproof Blog.]]> http://www.bulletproofblog.com/2009/08/17/what%e2%80%99s-next-the-bulletproof-interview-%e2%80%93-mike-rozembajgier-of-stericycle%e2%80%99s-expert-recall-team-on-a-new-era-of-recall-regulation/feed/ 0 http://www.bulletproofblog.com/2009/06/17/zicam-recall-shows-matrixx-cares/ http://www.bulletproofblog.com/2009/06/17/zicam-recall-shows-matrixx-cares/#comments Wed, 17 Jun 2009 21:20:27 +0000 David Bartlett http://www.bulletproofblog.com/?p=413 newly-energized agency is Zicam, an over-the-counter cold and allergy product that some users claim has damaged their sense of smell.

Unlike prescription drugs, over-the-counter remedies like Zicam don' t require FDA approval before they go on the market. But since 2007, companies have been required to report what are called "adverse events" related to their products. After the agency spotted the Zicam complaints in a routine review, it warned Matrixx that it was failing to follow the rules.

Then yesterday, with considerable fanfare, the FDA issued a warning that advised the public to stop using Zicam nasal swabs and gels. The agency doesn' t have the authority to order a recall, but within 24 hours of the warning, Matrixx voluntarily began pulling the product off the shelves, even though the company still disputes the FDA' s scientific findings.

Rather than pick a public fight with the FDA over the science that led the agency to issue its warning, however, Matrixx has wisely decided to make it clear that public safety comes first. A public fight with the FDA can wait for another day.

Brett Berty of Stericycle ExpertRECALL, the same company that managed the massive Vioxx withdrawal, sees this move as one that can transform a serious crisis into an opportunity for Matrixx. According to Berty, "Even with all the initial bad publicity, Matrixx still has a chance to position itself as part of the solution rather than part of the problem - just as Johnson and Johnson did when it decided to pull Tylenol off the shelves - something that wouldn' t have been possible without clearly demonstrating that safety comes first."

Whether the FDA' s concerns about Zicam will stand up to scientific scrutiny remains to be seen. But in the meantime, by moving to pull their product off the shelves, Matrixx is addressing a serious reputation management challenge the right way, by putting public health and safety ahead of the bottom line.

David Bartlett is a Senior Vice President at Levick Strategic Communications, an expert communications strategist and crisis manager, and a contributing author to Bulletproof Blog.]]> http://www.bulletproofblog.com/2009/06/17/zicam-recall-shows-matrixx-cares/feed/ 0 http://www.bulletproofblog.com/2009/03/19/in-zeal-to-reform-food-safety-don%e2%80%99t-create-a-cat-and-mouse-game/ http://www.bulletproofblog.com/2009/03/19/in-zeal-to-reform-food-safety-don%e2%80%99t-create-a-cat-and-mouse-game/#comments Thu, 19 Mar 2009 20:22:01 +0000 Gene Grabowski http://www.bulletproofblog.com/?p=321 The New York Times, President Obama is seeking to tear down and rebuild the U.S. food safety system. With consumer alarm at all-time highs over recent recalls of peanut products, tomatoes, spinach, and pet food, it' s no surprise the president has bipartisan support in Congress and an Agriculture Secretary who sees "a grand opportunity" to revamp food regulation in America.

With food contamination killing an estimated 5,000 people and sickening another 76 million each year, there' s broad consensus that something should be done to enhance government efforts to keep the U.S. food supply safe.

For example, the newly announced Food Safety Working Group - which includes the secretaries of Agriculture and Health - will likely push for increasing the number of on-site inspections at food processing plants. Other ideas under discussion are the imposition of food-safety inspection systems, mandatory federal recalls, and harsher financial and criminal penalties against branded food companies that fall short of standards.

Whatever the working group recommends, its members would do well to remember that when it comes to food safety, the public and private sectors work best when they work together. In fact, our public-private food inspection system is a big reason the United States still enjoys the safest, most affordable, and most abundant food supply in the world.

The current food-safety system, imperfect as it is, was designed to encourage cooperation between government and business so that costs to the taxpayers are controlled and companies are encouraged to comply with regulations. Ingeniously, the U.S. food-safety system is built on the premise that a food company has a powerful incentive to avoid contamination or risk damage to its most important possession - the brand name. It' s the FDA' s power of the press release - not fines or recalls imposed by bureaucrats - that serves as the primary deterrent in the U.S. system.

If food safety devolves into a cat-and-mouse game defined solely by stricter standards and harsher penalties for non-compliance, then the natural inclination of business will be to hide problems, rather than help eliminate them. We could end up in a regulatory environment in which the temptation to cover-up and obfuscate has been enhanced - and more Peanut Corporations of America try to cover their tracks rather than come clean.]]> http://www.bulletproofblog.com/2009/03/19/in-zeal-to-reform-food-safety-don%e2%80%99t-create-a-cat-and-mouse-game/feed/ 0 http://www.bulletproofblog.com/2009/02/12/business-beware-the-elimination-of-preemption/ http://www.bulletproofblog.com/2009/02/12/business-beware-the-elimination-of-preemption/#comments Thu, 12 Feb 2009 13:43:00 +0000 David Bartlett http://www.bulletproofblog.com/?p=290 Supreme Court decisions in many years could end in a draw, and that would be bad news for any business now regulated by the federal government.

Wyeth v. Levine involves a Vermont woman who lost her hand after an intravenous anti-nausea drug was improperly administered. She sued, and a state court awarded her damages, even though the company that makes the drug, Wyeth, argued that it wasn' t the drug, but rather the way it was improperly injected, that caused the injury.

The issue now before the Supreme Court is federal "preemption." Since the drug was approved by the FDA, Wyeth argued that federal law automatically takes precedence over any state court ruling. With state regulators, especially attorneys general, on the prowl for new causes to pursue, preemption is no small matter for any company whose products or services are regulated at the federal level.

State attorneys general have made no secret of the fact that they are on the lookout for the next billion dollar tobacco settlement. If the Vermont decision is allowed to stand and federal preemption is weakened or eliminated, look for a chaotic 50 state regulatory assault on companies in all sorts of regulated industries. Unfortunately, because of a completely unexpected development in this particular case, the Supreme Court may miss the opportunity to step in.

Since the Levine case was argued last fall, Wyeth has accepted a $68 billion buyout offer from Pfizer. And it turns out that Chief Justice John Roberts owns some Pfizer stock. Since the eventual outcome of the case could have an impact on Wyeth' s market value, this creates a potential conflict of interest. As a result, Roberts may choose not to take part in the Court' s decision. That could force a four-four tie, allowing the Vermont court ruling to stand.

Last year, Roberts did decide to sit out another case involving Pfizer, resulting in a tie vote.  Roberts has offered no hint of his intentions this time around, but if he decides not to take part in the Levine decision and his fellow justices again split 4-4, the Court will have missed an opportunity to clarify an important legal issue. But even worse, hungry state regulators will have a clear shot at a wide range of regulated businesses, an opportunity you can bet they will seize at the first chance they get.]]> http://www.bulletproofblog.com/2009/02/12/business-beware-the-elimination-of-preemption/feed/ 0 http://www.bulletproofblog.com/2009/01/21/peanut-butter-recall-part-ii/ http://www.bulletproofblog.com/2009/01/21/peanut-butter-recall-part-ii/#comments Wed, 21 Jan 2009 21:10:56 +0000 Gene Grabowski http://www.bulletproofblog.com/?p=271 Marler Clark has filed the first lawsuit tied to the current salmonella outbreak in certain suspected brands of peanut butter against a supplier to Kellogg Co. and McKee Foods. Those companies have voluntarily recalled several of their products in recent weeks. Another firm, PritzkerLaw, of Minneapolis, plans to file its own suit on behalf of a 72-year-old woman who died in a nursing home allegedly after eating peanut butter.

So far, six people have died and more than 470 have been sickened in 43 states. State and federal health authorities have traced the salmonella strain to peanut butter and paste that originated in a Georgia plant owned by the supplier, Peanut Corporation of America (PCA). As a result, the FDA has advised consumers not to eat cookies, cakes, ice cream and other foods that contain peanut butter or peanut butter paste.

Just as was the case with wholesale pet food supplier Menu Foods during the North American pet food recalls of 2007, brand-name food companies are suffering for the sins of suppliers to whom they have outsourced the production of ingredients. Unlike the supply chains of 40 years ago, food, drug and consumer product companies now seldom own or operate the plants where raw ingredients for their branded products are made. That makes it more difficult to control quality and especially hard to streamline a crisis response when a recall occurs.

In this case, for example, Kellogg, McKee Foods and even other branded food manufacturers were frustrated in their initial attempts to obtain clear information from PCA and translate that information into clearly defined messages to millions of confused consumers. Operating as a stand-alone (and largely anonymous) company, PCA had its own operation to protect, while branded food companies bore the brunt of publicity - and the attendant costs of recalls - in their efforts to prevent damage to brands familiar to consumers.

In today' s complex global marketplace, with supply chains often stretching around the world, brand-name companies must now take their suppliers into account when preparing crisis communications plans. In some cases, those companies will have to coordinate and approve crisis plans for their suppliers. In fact, the best-managed companies will integrate their suppliers into their crisis communications planning so that implementation is swift, seamless, and efficient. Most important, suppliers must be made to feel accountable for protecting the brands that reassure consumers and drive business growth.

After all, even a supply chain is only as strong as its weakest link.]]> http://www.bulletproofblog.com/2009/01/21/peanut-butter-recall-part-ii/feed/ 0